[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"European Organisation for Research and Treatment of Cancer - EORTC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":610},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,46,76,103,131,157,181,208,238,261,287,310,352,376,405,427,449,470,498,537,557,583],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100535001","phase-3-adjuvant-tebentafusp-in-high-risk-ocular-melanoma-100535001",false,"NCT06246149","Adjuvant Tebentafusp in High Risk Ocular Melanoma","Adjuvant Tebentafusp (IMCgp100) Versus Observation in HLA-A*02:01 Positive Patients Following Definitive Treatment of High-risk Uveal Melanoma: an EORTC Randomized Phase III Study (ATOM Trial)","ATOM","Inclusion Criteria:\n\n* Primary non-metastatic UM, except iris melanoma, after definitive treatment either by surgery or radiotherapy\n* Time from primary treatment smaller than 11 weeks (note that the maximum time between primary treatment and randomization is 12 weeks )\n* High-risk according to either 1) clinical criteria: TNM (AJCC8) stage III or 2) genetic criteria: monosomy 3 or GEP class 2. Prior to enrolment of the first patient, each site will declare which of the two genetic criteria it uses. Patients with stage I and stage II are only eligible if they meet the genetic criterion declared by the site.\n* ECOG performance status of 0 or 1\n* 18 years or older\n* HLA-A\\*02:01 positivity by local assessment\n* No evidence of UM recurrence, as evidenced by the required baseline imaging performed within 4 weeks prior to randomization\n* Adequate organ function\n* Time-interval between the end of primary treatment and the randomization less than or equal to 12 weeks\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for women of childbearing potential (WOCBP) within 3 days prior to randomization.\n* For patients of childbearing \u002F reproductive potential, agreement to use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n* For female subjects who are breast feeding, agreement to discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.\n* Written informed consent according to ICH\u002FGCP and local regulations\n\nExclusion Criteria:\n\n* Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n* Clinically significant and\u002For uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment\n* QTcF \\> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome based on at least 3 ECGs obtained over a brief time interval (i.e., within 30 minutes)\n* Acute myocardial infarction or unstable angina pectoris \\\u003C 6 months prior to screening\n* Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to randomization\n* Any evidence of severe or uncontrolled systemic disease or active infection including hepatitis B, hepatitis C and known active human immunodeficiency virus (HIV) defined as \\>200 copies of HIV per ml of blood, active bleeding diatheses or renal transplant. NOTE: testing for HIV, HBV, and HCV status prior to enrolment is not necessary unless clinically indicated.\n* Participant with history of HBV infection will be eligible if on stable anti-viral therapy for \\> 4 weeks prior to the planned first dose of study intervention and viral load confirmed as undetectable during Screening.\n* Participant with history of HBC infection will be eligible the participant has received curative treatment and viral load was confirmed as undetectable during Screening.\n* History of another primary malignancy except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and with the following exception. Patients with a history of another primary cancer treated with curative intent more than 3 years before study entry, who are not receiving any anti-cancer therapy, have a risk of disease recurrence lower than 10% as evaluated by the local Investigator, and who have no toxicity from previous treatment are eligible.\n* Participants with active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease (ulcerative colitis or Crohn's disease), within 2 years of screening. NOTE: The following exceptions are permitted:\n* Vitiligo\n* Alopecia\n* Managed hypothyroidism (on stable replacement doses)\n* Asymptomatic adrenal insufficiency (on stable replacement doses)\n* Psoriasis\n* Resolved childhood asthma\u002Fatopy\n* Well-controlled asthma\n* Type I diabetes mellitus\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.\n* Known contraindication to imaging tracer or any product of contrast media and MRI and\u002For CT contraindications","ALL","18 Years",{"count":20,"type":21},290,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","At least 50% of patients with high-risk primary uveal melanoma will develop a recurrence following treatment of the primary tumour. Observation is currently the standard of care in the non-metastatic setting. Tebentafusp is the first agent proven to improve overall survival in patients with metastatic uveal melanoma in a randomized trial. Based on the results in the advanced setting, it is hypothesized that treatment with tebentafusp may reduce the risk of development of disease recurrence.",[27],"Uveal Melanoma",[29,30,31,32],"Tebentafusp","Adjuvant setting","Randomized phase III study","non-metastatic uveal melanoma","RECRUITING","2026-06-29",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":37},"2024-11-11",{"date":41,"type":21},"2032-11",{"name":43,"class":44},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",15,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100273106","specta-screening-cancer-patients-for-efficient-clinical-trial-access-100273106","NCT02834884","SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access","SPECTA","* Patients with pathologically confirmed selected tumor types (at site or centrally);\n* Mandatory availability of adequate human biological material (HBM);\n* Centrally performed confirmation of HBM adequacy in terms of quality and quantity for SPECTA downstream project requirements;\n* Age ≥ 12 years;\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;\n* Written informed consent according to applicable legal and ethical requirements;","12 Years",{"count":55,"type":21},4975,"5 Years","OBSERVATIONAL","SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care.",[60],"All Tumor Types",[62,63,64,65,66],"rare cancer","biomarker","molecular screening","cancer","biobanking","2026-06-19",{"date":69,"type":37},"2026-06-24",{"date":71,"type":37},"2017-05-03",{"date":73,"type":21},"2031-10",{"name":43,"class":44},136,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100541156","phase-2-177lu-dotatate-for-recurrent-meningioma-100541156","NCT06326190","177Lu-DOTATATE for Recurrent Meningioma","177Lu-DOTATATE for Recurrent Meningioma: a Randomized Phase II Study","LUMEN-1","Inclusion Criteria:\n\n* Adult patient ≥ 18 years of age\n* Histologically confirmed diagnosis of meningioma (all grades, 1-3 per WHO CNS5, are eligible)\n* WHO performance status 0-2\n* Measurable disease (at least 10 x10 mm contrast enhancing lesion) on cranial MRI no more than two weeks prior to randomization\n* Radiologically documented progression of any existing tumour (growth \\> 25% in the last two years) or appearance of new lesions (including intra- and extracranial manifestations)\n* Somatostatin receptor (SSTR)-positive confirmed by PET imaging with scan performed within four weeks before randomization (baseline SSTR-PET is considered as positive when meningioma uptake intensity exceeds a SUVmax of 2.3).\n* At least one prior surgery and one line of external beam radiotherapy for meningioma\n* Adequate liver, renal and haematological function within four weeks prior to randomization (1) Neutrophils ≥ 1.5 x 109\u002FL, hemoglobin ≥ 9 g\u002FdL or hemoglobin ≥ 5.6 mmol\u002FL, platelets ≥ 100 x 109\u002FL, (2) Total Bilirubin ≤ 1 x ULN, SGPT\u002FALT and SGOT\u002FAST ≤ 2.5 x ULN, (3) Albumin ≥ 30 g\u002FL, (4) Serum creatinine ≤ 1.5 x ULN, (5) Creatinine clearance \\> 40 ml\u002Fmin as calculated by CKD-EPI 2021\n* Participants must have the following electrolyte values within normal limits or corrected to be within normal limits with supplements prior to first dose of study medication: (1) Potassium (potassium level of up to 6.0 mmol\u002FL is acceptable at study entry if associated with creatinine clearance within normal limits calculated using CKD-EPI formula). Mild decrease below lower limit of normal (LLN) is acceptable at study entry if considered not clinically significant by investigator, (2) Magnesium, with the exception of magnesium level \\> ULN - 3.0 mg\u002FdL (1.23 mmol\u002FL) associated with creatinine clearance within normal limits calculated using CKD-EPI formula. Mild decrease below LLN is acceptable at study entry if considered not clinically significant by Investigator, (3) Total calcium (corrected for serum albumin) level of up to 12.5 mg\u002FdL (3.1 mmol\u002FL) is acceptable at study entry if associated with creatinine clearance within normal limits calculated using CKD-EPI formula. Mild decrease below LLN is acceptable at study entry if considered not clinically significant by Investigator.\n* Patients who are receiving corticosteroid treatment with dexamethasone, must be treated with a dose of ≤4 mg\u002Fday (or other corticosteroids equivalent dose) for a minimum of 7 days initiation of study treatment.\n* Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to randomization. A positive urine pregnancy test result must immediately be confirmed using a serum test. A pregnancy test is to be reported within 7 days prior to the first dose of the study treatment. Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.\n* Patients of childbearing \u002F reproductive potential should use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include: (1) Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), (2) Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), (3) Intrauterine device (IUD), (4) Intrauterine hormone-releasing system (IUS), (5) Bilateral tubal occlusion, (6) Vasectomized partner, (7) Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)\n* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 7 months after the last study treatment.\n* Before patient 's enrolment, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Local therapy (surgery and \u002F or radiotherapy) indicated per local investigator. Note: in case of patients with multiple meningioma lesions, in whom resection and \u002F or radiotherapy of individual lesions is indicated, patients may be included after local therapy (with a 4-week gap between surgery \u002F end of radiotherapy and start of treatment), if at least one remaining lesion fulfils the inclusion criteria.\n* Any combined or any prior systemic treatment regardless the timing.\n* Life expectancy is less than nine weeks.\n* History of any other invasive malignancy within the last five years (except adequately treated non-melanoma skin cancer, clinically localized and very low-risk prostate cancer, and adequately treated cervical intraepithelial neoplasia)\n* Suspected pregnancy or when pregnancy has not been excluded\n* Contraindication to MRI, CT or PET\n* Unstable cardiac conditions (congestive heart failure, angina pectoris, myocardial infarction within one year before randomization, uncontrolled hypertension, clinically significant arrhythmias)\n* Psychological, familial, sociological, or geographical conditions potentially hamper compliance with the study protocol and follow-up schedule.\n* Known hypersensitivity to the active substance or to any excipients.",{"count":75,"type":21},[86],"PHASE2","Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine \"theranostic\" concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand.\n\nThe rationale for the LUMEN-1 trial is based on the following: (a) high somatostatin receptor (SSTR) expression in meningiomas, (b) wide-spread availability of clinically established SSTR-PET imaging, (c) proven efficacy of SSTR-targeting radioligand therapy using \\[177Lu\\]Lu-DOTATATE in another tumor type (neuroendocrine tumors), and (d) promising experiences with \\[177Lu\\]Lu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas. LUMEN-1 is the first randomized clinical trial to investigate \\[177Lu\\]Lu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area.",[89],"Recurrent Meningioma",[91,92,89,93],"177Lu-DOTATATE","Meningioma","Phase II","2026-06-12",{"date":96,"type":37},"2026-06-15",{"date":98,"type":37},"2025-03-10",{"date":100,"type":21},"2028-12-22",{"name":43,"class":44},19,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100508722","phase-3-lomustine-with-and-without-reirradiation-for-first-progression-of-glioblastoma-a-randomized-phase-iii-study-100508722","NCT05904119","Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study","LEGATO","Inclusion Criteria:\n\n* Before patient's enrolment, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n* Patients with first progression or recurrent glioblastoma after standard chemoradiotherapy (any treatment other than use of nitroureas) having occurred at least 6 months after the end of prior radiotherapy\n* Measurable disease according to RANO criteria with a maximum tumour diameter of 5 cm (local investigator assessment)\n* In case of surgery for recurrence: fully recovered from surgery, confirmation of recurrence by histology, and patient fit for treatment as per local investigator assessment.\n* Histologically proven diagnosis of glioblastoma, IDH wildtype per WHO 2021 classification and local assessment of tissue from diagnosis or recurrence\n* Initial treatment of newly diagnosed glioblastoma by maximal safe resection and postsurgical concurrent conventionally fractionated or abbreviated (minimum 15 fractions) chemoradiotherapy with or without maintenance chemotherapy with temozolomide (patient must have received at least one dose)\n* Stable or decreasing dose of steroids for 7 days prior to enrolment\n* Age ≥ 18 years\n* WHO Performance status of 0-2\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment.\n* Patients of childbearing \u002F reproductive potential must agree to use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of study treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.\n* Non-sterile males must use contraception during treatment and for 6 months after the last dose.\n* Non-sterile males must avoid sperm donation for the duration of the study and for at least 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Any prior anticancer treatment for recurrent glioblastoma (except surgery)\n* Significant reduction in thrombocyte and\u002For leukocyte counts as well as severe renal impairment according to investigator's opinion\n* History or present acute leukaemia or any myeloid disease\n* Known hypersensitivity to the active components or excipients of lomustine\n* Known coeliac disease or wheat allergy\n* Live attenuated vaccine in the 3 months prior to lomustine initiation\n* Any serious or uncontrolled medical condition (e.g., infections, chronic alcoholism, drug addiction) or abnormality, in the judgment of the investigator that prohibits obtaining informed consent, safe participation and study completion\n* Known contraindication to imaging tracer or any product of contrast media and Magnetic Resonance Imaging (MRI) contraindications\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.",{"count":111,"type":21},411,[24],"Despite comprehensive multimodal treatment of newly diagnosed glioblastoma, almost all patients suffer from tumour relapse. Currently, no standard of care exists to treat these tumour relapses. Treatment options include repeated surgery (if feasible), systemic therapy (bevacizumab, lomustine, temozolomide re-challenge), reirradiation and best supportive care. Currently, the superiority of combined chemoradiation versus chemotherapy alone remains unproven. Given that lomustine is the standard chemotherapeutic agent for the treatment of recurrent glioblastoma in Europe and the unclear efficacy of reirradiation, we want to explore whether combining lomustine and reirradiation may be a better treatment than lomustine alone. The results of the prospective randomized trial proposed here should demonstrate a significant improvement in overall survival when lomustine is combined with reirradiation in patients with recurrent glioblastoma compared to lomustine alone without adversely affecting quality of survival. The trial will be stopped based on overall survival in a preplanned futility and efficacy interim analysis.",[115],"First Progression of Glioblastoma",[117,118,119,120,121],"First progression","Glioblastoma","Phase III","Lomustine","Reirradiation","2026-06-05",{"date":124,"type":37},"2026-06-08",{"date":126,"type":37},"2024-03-15",{"date":128,"type":21},"2028-02",{"name":43,"class":44},45,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100610999","phase-2-phase-ii-study-of-upfront-srt-plus-ivonescimabchemotherapy-vs-ivonescimabchemotherapy-in-nsclc-brain-mets-100610999","NCT07234877","Phase II Study of Upfront SRT Plus Ivonescimab\u002FChemotherapy vs Ivonescimab\u002FChemotherapy in NSCLC Brain Mets","A Randomized Phase II Study Evaluating Upfront SRT to All Brain Metastases Followed by Ivonescimab Plus Chemotherapy Versus Upfront Ivonescimab Plus Chemotherapy in Patients With Asymptomatic Active Brain Metastases From NSCLC","Inclusion Criteria:\n\n* Age 18 years or older\n* ECOG PS \\\u003C= 2\n* Patients with pathology proven metastatic NSCLC without an actionable genomic alteration for which there is first line targeted treatment approved by EMA and recommended by the ESMO guidelines.\n* Asymptomatic or clinically symptomatic brain metastases defined as requiring a dose of steroids of maximum 4 mg equivalent dexamethasone per day for the last 7 days to control neurological symptoms. With the clinically oligosymptomatic further defined as having no indication for immediate localized brain therapy, including neurosurgery or radiotherapy. Patients with controlled seizures can be enrolled.\n* Newly diagnosed brain metastasis with the following characteristics:\n\n  * 1-10 newly diagnosed and untreated (except resected) brain metastases Note: if the neuronavigation MRI in the upfront SRS\u002FFSRT arms shows \\> 10 metastases, but the MRI used for enrolment showed 1-10 metastases, the patient will be still considered eligible.\n  * At least one metastasis should be at least 5x5 mm. In case of doubt on the diagnosis of brain metastasis, the lesion should not be irradiated but followed up.\n  * The largest metastasis must be \\\u003C10 mL in volume and \\\u003C30 mm in longest diameter (resected lesions would not count).\n  * The maximum cumulative volume of brain metastases must be \\\u003C30 mL (resected lesions would not count)\n* Adequate Organ Function\n\nExclusion Criteria:\n\n* Patients with oligometastatic NSCLC who are scheduled to receive radical local treatment to extra-cranial sites.\n* Patients with contra-indications to brain MRI with gadolinium-based contrast agent.\n* Active auto-immune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n* Patients with \\>30 Gy of chest radiation therapy within 6 months prior to randomization; non-thoracic radiation therapy \\>30Gy within 4 weeks prior to randomization, or palliative radiation therapy of ≤30 Gy within 7 days prior to randomization.\n* Prior brain irradiation (including whole brain radiotherapy and SRS).\n* Prior systemic treatment for metastatic NSCLC. Patients having received adjuvant or neoadjuvant chemotherapy or curative-intent chemoradiotherapy with or without PD-1\u002FL1 inhibitors can be enrolled if the adjuvant\u002Fneoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease.\n* Major surgical procedures or serious trauma within 4 weeks prior to randomization or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to randomization.\n* History of coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to randomization\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* History of serious cardiovascular, gastronintestinal, thromboembolic, neurological, or pulmonary conditions before randomization.\n* History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization",{"count":139,"type":21},158,[86],"This is a randomized, two-arm, comparative Phase II clinical trial designed to evaluate the difference in intracranial progression-free survival (iPFS) between two treatment strategies, assessed locally.\n\nApproximately 158 patients will be randomized in a 1:1 ratio. Will be included patients with pathology proven metastatic NSCLC without an actionable genomic alteration for which there is first line targeted treatment available and active asymptomatic brain metastasis (newly diagnosed or progressive).\n\nThe primary objective is to compare iPFS between the two arms.",[143],"Non Small Cell Lung Cancer",[145,146],"Ivonescimab","Phase II study","NOT_YET_RECRUITING","2026-06-02",{"date":150,"type":37},"2026-06-04",{"date":152,"type":21},"2026-11",{"date":154,"type":21},"2032-04",{"name":43,"class":44},26,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},"100576288","phase-2-radiopharmaceutical-treatment-of-advanced-kidney-cancer-100576288","NCT06783348","Radiopharmaceutical Treatment of Advanced Kidney Cancer","Phase II Trial Evaluating the Efficacy of 177Lutetium-PSMA-617 Treatment in Patients With Metastatic Clear Cell Renal Carcinoma Cell With Progressive Disease on First-line or Second-line Systemic Treatment","RENALUT","Inclusion Criteria:\n\nPRE-SCREENING\n\n* Histologically proven ccRCC. Sarcomatoid component is allowed.\n* Adult patients ≥18 years old.\n* Has progressed on or after ≥1-line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-programmed death-1 (receptor) \\[PD-1\\]\u002Fprogrammed death-ligand 1 (PD-L1) therapy +\u002F- ipilimumab and a VEGFR-TKI.\n* Written pre-screening informed consent according to ICH\u002FGCP and local regulations.\n\nSCREENING\n\n* Patients with at least one PSMA-positive metastatic lesion, and no exclusionary PSMA-negative lesions, with positive lesions defined as those with a maximum standardized uptake value (SUVmax) greater than the mean standardized uptake value (SUVmean) of liver background.\n* Measurable disease by RECIST 1.1 criteria.\n* Patients with adequate blood tests (Absolute neutrophil count \\> 1.5 x 109\u002FL, haemoglobin \\> 9.0 g\u002FdL, platelet count \\> 100,000\u002FµL, estimated glomerular filtration rate (GFR) ≥ 40 ml\u002Fmin by CKD-EPI formula, total bilirubin ≤ 1.5 x ULN. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases).\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to registration. A positive urine pregnancy test result must immediately be confirmed using a serum test. A pregnancy test is to be reported within 7 days prior to the first dose of the study treatment.\n\nNote: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.\n\n* Patients of childbearing \u002F reproductive potential should use adequate birth control measures during the study treatment period and for at least 14 weeks after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include:\n\n  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)\n  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n  * Intrauterine device (IUD)\n  * Intrauterine hormone-releasing system (IUS)\n  * Bilateral tubal occlusion\n  * Vasectomized partner\n  * Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)\n  * Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 3 months after the last study treatment.\n* Before patient's enrolment, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations. This includes consent to comply to recommended radioprotection precautions during study.\n\nExclusion Criteria:\n\n* Patient with RCC in a single kidney.\n* Patients with PSMA-negative lesions (defined as PSMA uptake equal to or lower than that of liver parenchyma) in any lymph node with a short axis of at least 15 mm, in any metastatic solid-organ lesions with a short axis of at least 1.0 cm, or in any metastatic bone lesion with a soft-tissue component of at least 1.0 cm in the short axis. Patients with any PSMA-negative metastatic lesion meeting these criteria are ineligible.\n* Other malignancy that is expected to interfere with the treatment or results of this study, such as prostate cancer.\n* Patient with active uncontrolled or symptomatic central nervous system (CNS metastases).\n\nNote: patients treated previously with radiotherapy and\u002For surgery resulting in controlled\u002Fasymptomatic CNS disease are allowed.\n\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the in the trial.\n* Known contraindication to imaging tracer or any product of contrast media.","100 Years",{"count":167,"type":21},48,[86],"Background This study is for adults with advanced kidney cancer that has spread to other parts of the body and has continued to progress despite treatment with immunotherapy and targeted therapy. Unfortunately, treatment options at this stage of the disease are limited. The existing treatments' ability to work against cancer has not been fully looked into.\n\nRationale The goal of this study is to examine if a new drug treatment called 177Lutetium-PSMA-617, hereafter referred as 177Lu-PSMA-617, which holds the active ingredient 177Lutetium-PSMA and has been used as a standard treatment for advanced prostate cancer since December 2022, can also help treat advanced kidney cancer.\n\nThe drug 177Lu-PSMA-617 is being tested as an experimental treatment that targets a specific protein on cancer cells. This protein, known as prostate-specific membrane antigen (PSMA), is present on the surface of kidney cancer cells. Therefore, before the treatment begins, participants will undergo a PET (positron-emission tomography) scan to check if their kidney cancer cells express high levels of PSMA. This scan uses a small amount of radioactive material (in the form of 177Lutetium) to visualize the presence of PSMA on the cancer cells. Only participants who test positive for PSMA can take part in the study. In this approach, PSMA serves two purposes. First, it helps assess whether the cancer expresses this protein and allows 177Lu-PSMA-617 to specifically target and attach to the cancer cells. Second, 177Lu-PSMA-617 delivers a small amount of radiation directly to the tumour, which helps kill cancer cells while minimizing damage to normal cells. This type of treatment is known as a radiopharmaceutical.\n\nObjective The primary aims are to find out if 177Lu-PSMA-617 is useful against kidney cancer and to assess its safety. Throughout the study, participants will undergo several imaging assessments to check their disease and response to treatment.\n\nThe study also includes the collection of tissue samples. Together with the information collected from the imaging assessments, this will allow further research into markers that may lead to earlier detection of tumour spread or help identify individuals who may benefit more from treatment with 177Lu-PSMA-617.\n\nTreatment All participants will receive 177Lu-PSMA-617 through an intravenous injection at a standard dose of 7,400 MBq (megabecquerel: a measure of radioactivity). Treatments will be administered approximately every six weeks, for a maximum of six times.\n\nBlood tests are done before and during treatment to check the participant's health and to detect any early side effects from the treatment. Different types of scans are performed before, during, and after 177Lu-PSMA-617 administration to check how well the treatment is working. After treatment ends, follow-up visits will be scheduled every six weeks during the first year. In the second year, your doctor will decide how often you need to come in for visits. These appointments are important for monitoring how the body continues to respond to the treatment. The entire study period will last approximately two years from the time of study entry.\n\nParticipants\n\nThe study will include approximately 56 participants who will be tested for PSMA expression, to obtain a minimum of 48 participants expressing PSMA entering the study. To qualify, participants must:\n\n* Be diagnosed with advanced kidney cancer previously treated with immunotherapy and targeted therapy.\n* Test positive for PSMA on a PET scan.\n* Be generally healthy and able to perform daily activities.\n* Be at least 18 years of age.\n\nBenefit-risk analysis The drug 177Lu-PSMA-617 has proven to work well in treating advanced prostate cancer and could be a promising new treatment possibility for kidney cancer, although this has not yet been shown. By joining this study, participants will contribute to valuable research to better understand kidney cancer and improve treatment options for future patients. Participating in this study offers a chance to try a new treatment, which might help people with advanced kidney cancer live longer and prevent the disease from getting worse, especially for those who have limited treatment options left after immunotherapy and targeted therapy.\n\nWith all new treatments, there are possible risks and side effects associated with them. Side effects of the drug 177Lu-PSMA-617 may include feeling tired, nausea, dry mouth, loss of appetite, and changes in blood cells. While not all side effects are known yet, the study team will carefully follow participants for any side effects during and after treatment. It is important to understand that while the study is being done to provide new information, there are still some questions on the treatment's safety and how well it will work.",[171],"Metastatic Clear Cell Renal Cell Carcinoma",[173],"renal cancer",{"date":150,"type":37},{"date":176,"type":37},"2026-04-07",{"date":178,"type":21},"2029-01-01",{"name":43,"class":44},2,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},"100501951","phase-3-pembrolizumab-and-radiotherapy-for-oligometastatic-head-and-neck-cancer-100501951","NCT05815927","Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer","Pembrolizumab and Radiotherapy for OLigometastatic Squamous Cell Carcinoma of the Head and Neck: a Randomized Phase III Study","PROLoNg","Main inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent\n* Histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx, larynx or cervical primary occult and histologically or radiologically confirmed oligometastatic disease. Histological characterization of one metastatic lesion is strongly recommended.\n* Patients with synchronous or metachronous oligometastatic disease according to the ESTRO\u002FEORTC consensus (1-5 metastatic lesions, with or without primary\u002Frecurrent primary tumour and\u002For regional disease).\n* Amenable to first-line systemic treatment for R\u002FM SCCHN.\n* For patients with oropharyngeal cancer: HPV status using p16 IHC evaluated locally.\n* PD-L1 CPS of at least 1 as evaluated locally.\n* Staging not older than 12 weeks before enrolment.\n* All the 1-5 metastases must be amenable to SABR.\n* Eligible for treatment with pembrolizumab.\n* Have measurable disease based on RECIST 1.1.\n* ECOG performance status of 0 to 1.\n* Participants must have recovered from all treatment-related toxicities to baseline or grade ≤1, such as from previous radiotherapy, systemic treatment or surgery, and not requiring corticosteroids for managing treatment-related side effects.\n* Adequate Organ Function Laboratory Values.\n* Before patient registration\u002Fenrolment, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nMain exclusion Criteria:\n\n* Nasopharynx, sino-nasal, and salivary gland cancers are excluded.\n* In-field progression in \\\u003C 6 months after curative intended locoregional irradiation of the head and neck.\n* Lesions larger than 6 cm in the largest dimension as measured in the diagnostic CT or MRI scan for lesions outside the brain. Note: bone metastases over 6 cm may be included if in the opinion of the local radiation oncologist they can be treated safely and no inner organ is affected.\n* Brain metastases only.\n* Has received any previous radiotherapy to any of the 1-5 metastases that would be subject to SABR in the experimental arm unless the investigator agrees to treat only after discussion with the RTQA team.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Previously treated brain metastases that are radiologically non-stable. Patients with previously treated brain metastases, i.e., without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention, can participate.\n* Known contraindication to imaging tracer or any product of contrast media and MRI contraindications.",{"count":190,"type":21},200,[24],"This is a randomized open-label multicentre phase III superiority study of the effect of adding SABR to the standard of care treatment pembrolizumab on progression free survival in patients with oligometastases of a squamous cell carcinoma of the head and neck (SCCHN), histological confirmation of the primary disease at first diagnosis, and PD-L1 CPS ≥1. After eligibility check and signing informed consent, all patients will be prospectively enrolled in a 1:1 ratio between current standard of care treatment (pembrolizumab, Arm 1) vs. SABR + standard of care treatment (Arm 2) to oligometastases.\n\nAny radical treatment to the synchronous primary\u002F recurrent primary tumor and\u002For involved cervical nodes (surgery or radiotherapy), as decided by the local tumor board\u002F treating physicians, should be completed prior to enrolment.Surgical removal of metastases is allowed for diagnostic purposes or for brain metastases, as long as these metastases count toward the total number of 5 and at least one metastasis is left for treatment with SABR. Such surgical procedures should be performed prior to enrolment.",[194],"Oligometastatic Squamous Cell Carcinoma of the Head and Neck",[196,197,198],"Pembrolizumab","Stereotactic ablative radiotherapy","oligometastatic HNSCC","2026-05-27",{"date":201,"type":37},"2026-05-28",{"date":203,"type":37},"2025-05-23",{"date":205,"type":21},"2030-03-30",{"name":43,"class":44},30,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},"100578286","phase-3-vorasidenib-maintenance-for-idh-mutant-astrocytoma-100578286","NCT06809322","Vorasidenib Maintenance for IDH Mutant Astrocytoma","Vorasidenib as Maintenance Treatment After First-line Chemoradiotherapy in IDH-mutant Grade 2 or 3 Astrocytoma: a Placebo-controlled, Triple-blind, Randomized Phase III Study (VIGOR)","VIGOR","Inclusion Criteria:\n\n* Before participant's enrolment, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n* Age ≥ 18 years\n* Integrated diagnosis of astrocytoma, IDH-mutant, WHO CNS5 grade 2 or 3, per local assessment\n* Documented IDH1 or IDH2 mutation based on local testing of tumour tissue\n* At least 1 prior surgery for glioma (biopsy, partial resection, gross-total resection)\n* Completed first-line standard of care radiotherapy (minimum 50.4 Gy, photons or protons allowed) followed by SoC adjuvant chemotherapy (i.e., either 4-12 cycles of temozolomide or 2-6 cycles of PCV).\n* Adequate bone marrow function: absolute neutrophil counts ≥ 1.5 x 109\u002FL, haemoglobin ≥ 9 g\u002FdL, platelets 100 x 109\u002F L.\n* Adequate renal function: serum creatinine ≤ 2.0 x ULN, or creatine clearance \\> 40 mL\u002Fmin, as calculated based on CKD-EPI 2021 formula.\n* Adequate hepatic function:\n\n  * Total bilirubin ≤ 1.5 × ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \\> 3.0 × ULN or direct bilirubin ≥1.5 × ULN)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 x ULN.\n  * Alkaline phosphatase (ALP) ≤ 2.5 x ULN.\n* Recovered from any clinically relevant toxicity of the previous chemoradiotherapy cycle unless stable and manageable per investigator´s judgement\n* WHO performance status 0-2\n* Stable or decreasing corticosteroid dose, or no use of corticoids, for at least 7 days prior to enrollment.\n* Baseline brain MRI available, as defined in the schedule of assessments\n* Available FFPE tumour tissue from prior neurosurgery for central biobanking and translational research\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within two weeks prior to enrolment.\n* Participants of childbearing \u002F reproductive potential should use two adequate methods of birth control, including a highly effective method and a barrier method during the study treatment period and for at least 90 days after the last dose of treatment.\n\nExclusion Criteria:\n\n* Presence of 1p19q co-deletion, per local assessment.\n* Tumour recurrence or progression per RANO 2.0 criteria between first day of radiotherapy and enrolment, per local assessment\n* Last chemotherapy dose of first line chemoradiotherapy less than 6 weeks or more than 12 weeks before enrolment\n* Prior therapy with an IDH inhibitor or IDH vaccine\n* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n* Integrated diagnosis of astrocytoma, IDH-mutated, CNS5 WHO grade 4\n* Pregnancy or breastfeeding\n* Significant known active cardiac disease within 6 months before enrollment, including New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, and\u002For stroke.\n* Known hypersensitivity to any of the components of vorasidenib.\n* Ongoing use of medications that are CYP2C8, CYP2C9, CYP2C19, or CYP3A substrates with a narrow therapeutic index. Participants must be transferred to other medications before receiving the first dose of study drug.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, known positive human immunodeficiency virus antibody results, or AIDS-related illness.\n\nParticipants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV that is adequately suppressed by institutional practice will be permitted.\n\n• Known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition that limits the gastrointestinal absorption of drugs administered orally.\n\nGastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential).\n\n* Inability or known contraindication to undergo contrast media MRI.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.",{"count":217,"type":21},468,[24],"The main goal of VIGOR is to demonstrate that vorasidenib maintenance therapy improves locally assessed progression-free survival (PFS) from enrolment compared to placebo in patients with IDH-mutant, CNS5 WHO Grade 2 or 3 astrocytoma following the completion of first-line chemoradiotherapy.\n\nThe primary endpoint is Progression-free survival (PFS), as assessed locally from the date of enrolment using the RANO 2.0 criteria.\n\nIn this a comparative, randomized (1:1), triple blinded, multicentre phase III superiority trial with one stopping rule for efficacy and futility after end of enrolment, participants in the experimental arm will receive vorasidenib orally once daily at a dose of 40 mg in continuous 28-day cycles while participants in the control arm will receive a matched oral placebo once daily in continuous 28-day cycles",[221],"IDH-mutant Grade 2 or 3 Astrocytoma",[223,224,225,226,227,228],"Astrocytoma","IDH-mutant grade 2 or 3","Vorasidenib","Placebo- controlled","Triple-blinded","Phase III study","2026-05-20",{"date":231,"type":37},"2026-05-22",{"date":233,"type":37},"2026-01-16",{"date":235,"type":21},"2037-05-31",{"name":43,"class":44},33,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":22,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100364933","phase-3-surgery-with-or-without-neoadjuvant-chemotherapy-in-high-risk-retroperitoneal-sarcoma-100364933","NCT04031677","Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma","A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)","STRASS2","1. STRASS 2\n\n   Inclusion Criteria:\n   * Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.\n   * LMS:\n\n     * Any grade LMS can be included\n     * Minimum size of LMS tumor should be 5 cm\n   * LPS:\n\n     * Diagnosis should be confirmed based on MDM2 (Mouse double minute 2 homolog) and CDK4 (Cyclin-dependent kinase 4) expression on IHC (immunohistochemistry), while proof of MDM2 amplification is highly recommended.\n     * All grade 3 DDLPS can be included.\n     * DDLPS with confirmed grade 2 on biopsy can be included when:\n\n       * The grade 2 DDLPS has an FNCLCC score=5 (Fédération Nationale des Centres de Lutte Contre Le Cancer), and clear necrosis on imaging (whether or not present on the biopsy).\n       * The tumors carry a high risk gene profile as determined by the Complexity INdex in SARComas (CINSARC-high)\n     * Unifocal tumour\n     * Resectable tumour: resectability is based on pre-operative imaging (CT-abdomen, potentially also with MRI) and has to be defined by the local treating sarcoma team. A patient is not considered resectable when the expectation is that only an R2 resection is feasible.\n     * Criteria for non-resectability are:\n     * Involvement of the superior mesenteric artery, aorta, coeliac trunk and\u002For portal vein\n     * Involvement of bone\n     * Growth into the spinal canal\n     * Progression of retro-hepatic inferior vena cava leiomyosarcoma towards the right atrium\n     * Infiltration of multiple major organs like liver, pancreas and or major vessels\n     * Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by imaging. CT thorax abdomen pelvis with IV contrast is the preferred imaging modality. In case of any contra-indications (medical or regulatory), it is allowed to perform a non-contrast CT thorax + MRI abdomen \\& pelvis\n     * Collection of tumour tissue for central pathology review is mandatory.\n     * For patients with LMS: if there is not enough tissue for assessing the grading, this is acceptable.\n     * If tumour tissue is not available for the central pathology review, patient will not be eligible.\n     * If the biopsy was not done or the FFPE of the biopsy not available but at least 10 unstained slides or one pathological block are available for the central review, that will be considered as acceptable.\n     * For the biopsy if fine needle aspiration (FNA) is performed instead of core needle biopsy (CNB) recommended by the standard guidelines, please contact the EORTC medical monitors for further evaluation.\n     * Collection of tumour tissue and blood samples for translational research is mandatory.\n     * In case there is not enough tissue for TR, a new biopsy is not required and if the patient fulfils all other eligibility criteria, he\u002Fshe will be eligible.\n     * If the blood samples are not collected, patient will not be eligible.\n     * If the patient refuses the collection of biomaterial for TR, patient will not be eligible even if he\u002Fshe fulfils all other eligibility criteria\n     * ≥ 18 years old (no upper age limit)\n     * WHO performance status ≤ 2\n     * Adequate haematological and organ function\n     * American Society of Anaesthesiologist (ASA) score \\\u003C 3\n     * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization.\n\n   Note: a woman is considered of childbearing potential, i.e., fertile, if she is following menarche. She remains of childbearing potential until she becomes post-menopausal or permanently sterile.Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n\n   A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 consecutive months without menses, a single FSH measurement is insufficient.\n   * WOCBP in both arms should use highly effective birth control measures, during the study treatment period and for at least 6 months after the last dose of chemotherapy or date of surgery (except for women receiving chemotherapy with ifosfamide who should continue contraception until 1 year after last day of treatment). A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n   * For men in the experimental arm: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.\n   * Female subjects who are breast feeding should discontinue nursing prior to the first day of study treatment and until 6months after the last study treatment.\n   * Before patient randomization, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\n   Exclusion criteria:\n   * Sarcoma originating from bone structure, abdominal or gynecological viscera\n   * Extension through the sciatic notch or across the diaphragm\n   * Metastatic disease\n   * Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour\n   * Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients\n   * Congestive heart failure\n   * Angina pectoris\n   * Myocardial infarction within 1 year before randomization\n   * Uncontrolled arterial hypertension defined as blood pressure ≥ 150\u002F100 mm Hg despite optimal medical therapy.\n\n   Note: in case of high blood pressure: 1) initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; 2) blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP \u002F DBP values from each blood pressure assessment must be ≤ 150\u002F90mmHg in order for a patient to be eligible for the study.\n   * Uncontrolled cardiac arrhythmia\n   * Previous treatment with maximum cumulative doses (450mg\u002Fm² Doxorubicin or equivalent 900mg\u002Fm² Epirubicin) of doxorubicin, daunorubicin, epirubicin, idarubicin, and\u002For other anthracyclines and anthracenediones\n   * Active and uncontrolled infections\n   * Vaccination with live vaccines within 30 days prior to study entry\n   * Inflammation of the urinary bladder (interstitial cystitis) and\u002For obstructions of the urine flow.\n   * Other invasive malignancy within 5 years, with the exception of adequately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason ≤ 6prostate cancer.\n   * Uncontrolled severe illness, infection, medical condition (including uncontrolled diabetes), other than the primary LPS or LMS of the retroperitoneum.\n   * Female patients who are pregnant or breastfeeding or female and male patients of reproductive potential who are not willing to employ effective birth control method.\n   * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial\n   * Known contraindication to imaging tracer and to MRI\n2. Selection criteria for STREXIT 2\n\n   * Patients with histologically proven primary resectable localized high-risk DDLPS or LMS of retroperitoneal space or infra-peritoneal spaces of pelvis (as described in the inclusion criteria of STRASS 2) and amenable to receive chemotherapy but for whom the list of eligibility criteria for the study is too restrictive (tumour grading not available, inadequate organ function, concomitant diseases)\n   * Patients who meet all eligibility criteria of STRASS 2 but do not consent to randomization or are not enrolled for any other reason.\n   * Patients enrolled in a Registry collecting data on primary RPS patients in the centres participating in STRASS 2 (e.g., RESAR) and who satisfy the above criteria.\n3. Selection criteria for preferences for neoadjuvant chemotherapy in STRASS 2 substudy\n\nAll patients recruited to STRASS 2 in participating centres (Australia +\u002F- international sites) that are able to read, comprehend and write in English at a sufficient level to complete study materials.",{"count":247,"type":21},250,[24],"This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.\n\nAfter confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.",[251,252,253],"Retroperitoneal Sarcoma","Liposarcoma","Leiomyosarcoma",{"date":231,"type":37},{"date":256,"type":37},"2021-01-20",{"date":258,"type":21},"2028-04-21",{"name":43,"class":44},169,{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"100478622","phase-3-elacestrant-for-treating-erher2--breast-cancer-patients-with-ctdna-relapse-treat-ctdna-100478622","NCT05512364","Elacestrant for Treating ER+\u002FHER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)","Elacestrant for Treating ER+\u002FHER2- Breast Cancer Patients With ctDNA Relapse","TREAT ctDNA","Inclusion Criteria:\n\n1. ctDNA screening phase:\n\n   Main inclusion criteria:\n\n   • Female (both pre- and postmenopausal) or male patients with histologically confirmed ER positive (regardless of PR),\n\n   HER2 negative breast cancer, according to local pathologist:\n   * ER-positive defined as ≥ 10% of cells staining positive for ER or Allred proportion score ≥3\n   * HER2-negative defined as a score of 0, 1+ by immunohistochemistry (IHC) or a negative in situ hybridization (ISH) based on single-probe average HER2 copy number, as per American Society of Clinical Oncology guidelines\n   * Intermediate to high risk of recurrence after definitive treatment for early breast cancer, defined as:\n\n   FOR PATIENTS TREATED WITH PRIMARY SURGERY:\n   * Any patient with ≥ 4 positive axillary lymph nodes (stage pN2-3).\n   * 1-3 positive axillary lymph nodes (stage pN1) and either:\n   * Tumour size ≥ 5 cm or\u002Fand\n   * Histologic grade 3 or\u002Fand\n   * Ki67≥20% or\u002Fand\n   * High genomic risk defined as Oncotype Dx Recurrence Score \\>=26, Mammaprint high risk, Prosigna score \\>40 or EPclin risk score \\>=4.0.\n   * Negative axillary lymph nodes (stage pN0) and tumour size ≥ 2 cm and either\n   * Histologic grade 3 a or\u002Fand\n   * Ki67≥20% and\u002For\n   * High genomic risk defined as Oncotype Dx Recurrence Score \\>=26, Mammaprint high risk, Prosigna score \\>60 or EPclin risk score \\>=4.0. FOR PATIENTS TREATED WITH NEOADJUVANT\n\n   SYSTEMIC TREATMENT FOLLOWED BY SURGERY:\n   * Patient may have received neoadjuvant endocrine therapy or neoadjuvant chemotherapy provided that:\n   * The initial tumour and\u002For the tumour after surgery meet the criteria above defined for patients treated with primary surgery or the initial tumour was staged as cT4anyN and\n   * There is no pathological complete response, defined as no invasive disease in the breast and axilla (ypT0\u002Fis ypN0).\n   * Age ≥18 years\n   * Patients must have received at least 1 year and up to 7.5 years of ET and planned to continue adjuvant ET during ctDNA screening phase\n   * Previous adjuvant CDK4\u002F6 inhibitor or PARP-inhibitor treatment is allowed provided it is completed\n   * Invasive multicentric \u002F multifocal disease is allowed provided that all the tested foci are ER+ HER2-. A sample from the highest-risk one, according to the investigator decision based on the size and grade, should be sent to Natera to build the patient ctDNA assay.\n   * Available tumour sample from resected or biopsied tissue, with a tumour content of ≥20% (30% preferred) either before or after macro dissection (if performed) and a cell viability of a minimum 100 cells.\n   * Core Needle Biopsies (CNB): recommended minimum of four (4) cores per block\n   * Fine Needle Aspirates (FNA) are not accepted\n   * The following sample types are acceptable:\n   * 6-10 unstained slides (charged and unbaked) of 10μm each (or 12-19 unstained slides at 5 μm each), PLUS one contiguous H\\&E slide. Minimum total tissue thickness must be 60μm OR\n   * FFPE tissue block with 25mm2 minimum surface area\n   * Written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\n   Main exclusion criteria:\n   * Suspected recurrent disease or known conflicts with the inclusion and exclusion criteria for the randomised trial\n   * Prior treatment with any SERD or investigational ER antagonist\n   * Previous history of invasive breast cancer\n   * Previous history of any other malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n   * Previous history of bone marrow and\u002For organ transplant\n   * Bilateral invasive breast cancer\n   * Participation in another clinical study, with the exception of the SURVIVE study and observational (non-interventional) and non-drug intervention clinical studies. Note: patients participating in interventional studies may participate once they enter the follow-up period of the study\n   * Blood transfusion within 3 months prior to registration or during the screening.\n2. Randomised trial:\n\nMain inclusion criteria:\n\n* ctDNA positive according to the Signatera ctDNA assay (main study ctDNA test) or other ctDNA assay approved for diagnostic purposes.\n* Patients must meet the eligibility criteria for the screening phase, with the exception of the tissue sample requirements.\n* Patients must receive adjuvant ET at the time of the ctDNA positive test\n* Absence of locoregional and\u002For metastatic disease and\u002For new malignancy, as investigated by:\n* Mammogram (unilateral in case of mastectomy; not required in patients having undergone bilateral mastectomy) NOTE: if local investigator plans to use MRIs instead of mammograms during the study, MRI will have to be performed at baseline.\n* CT thorax and abdomen\u002Fpelvis with IV contrast. In case of any contra-indications (medical or regulatory): CT thorax without contrast + MRI abdomen\u002Fpelvis.\n* Technetium-99m bone scintigraphy\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate organ function\n* Women of childbearing potential (WOCBP) must have a negative highly sensitive serum or urine pregnancy test within 7 days prior to randomisation.\n\nMain exclusion criteria:\n\n* Any unresolved toxic effect of prior therapies or surgical procedures of Grade ≥ 2 according to Common Terminology Criteria of Adverse Events (CTCAE) v5.0, with the exception of alopecia, peripheral neuropathy and other toxicities not considered a safety risk for the participant at investigator's discretion\n* Unable or unwilling to avoid over-the-counter medications, dietary\u002Fherbal supplements, and\u002For foods that are moderate\u002Fstrong inhibitors or inducers of CYP3A4 activity\n* Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications\n* Any of the following cardiovascular disorders within 3 months before enrolment:\n* myocardial infarction\n* stroke\n* severe\u002Funstable angina\n* symptomatic cardiac arrhythmia\n* prolonged QTcF ≥ Grade 3 (i.e., \\> 500 msec)\n* heart failure ≥ Class III as defined by the New York Heart Association (NYHA) guidelines\n* CTCAE version 5.0 grade 3 or 4 dyslipidemia at the time of screening, defined as cholesterol\\>400 mg\u002FdL or \\>10.34 mmol\u002FL and\u002For triglycerides\\>500 mg\u002FdL or \\>5.7 mmol\u002FL.\n* Child-Pugh Score greater than Class A\n* Uncontrolled significant active infections (≥ grade 3 according to CTCAE version 5), including active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency Virus (HIV)\n* Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism",{"count":270,"type":21},220,[24],"This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+\u002FHER2- breast cancer and ctDNA relapse.\n\nDuring the ctDNA screening phase, patients will be tested at different timepoints to detect the presence of ctDNA in their blood.\n\nPatients who are found to be ctDNA-positive and have no evidence of distant metastasis, will be randomised 1:1 between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.",[274,275,276,277],"ER-positive Breast Cancer","HER2-negative Breast Cancer","Stage IIB Breast Cancer","Stage III Breast Cancer","2026-05-13",{"date":280,"type":37},"2026-05-15",{"date":282,"type":37},"2023-12-15",{"date":284,"type":21},"2035-11-01",{"name":43,"class":44},109,{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":295,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":4},"100625682","phase-2-flt3-itd-targeted-therapy-in-fit-aml-patients-100625682","NCT07425808","FLT3-ITD Targeted Therapy in Fit AML Patients","Gilteritinib in Combination With Azacitidine and Venetoclax Compared to Induction Chemotherapy \"7+3\" in Combination With a FLT3-inhibitor in Fit, Newly Diagnosed, FLT3-ITD Mutated Adult AML Patients: a Randomized Trial of the EORTC Leukemia Group and GIMEMA.","FIT-AML","Inclusion Criteria:\n\n* Newly diagnosed AML cytopathologically confirmed according to the 5th WHO classification\n* Age between 18 and 75 years\n* FLT3-ITD mutation as per local IVDR-compliant testing. Positivity is defined as a FLT3-ITD \u002F FLT3-wild type (WT) ratio of ≥ 0.05 (5%))\n* Eligibility for standard induction chemotherapy\n* ECOG PS ≤ 2\n* WBC ≤25 x 10\\^9\u002FL (hydroxyurea, leukapheresis or cytarabine in specific clinical circumstances, are allowed to meet this criterion. Please refer to Section 4.1.1 - Inclusion Criteria).\n* Adequate hepatic function (as indicated by total serum bilirubin level ≤2.5 x the institutional upper limit of normal range (UNL), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the investigator; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤3 x UNL)\n* Adequate renal function as defined by an eGFR ≥ 30 mL\u002Fmin according to the 2021 CKD-EPI equation\n\nMain Exclusion Criteria:\n\n* Acute promyelocytic leukemia (APL)\n* BCR-ABL positive leukemia or Ph1-positive chronic myeloid leukemia\n* History of myeloproliferative neoplasm (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera\n* Active central nervous system involvement by AML\n* Active, uncontrolled infection (viral, bacterial or fungal): an infection controlled with an approved or closely monitored antibiotic\u002Fantifungal treatment is allowed.\n* HIV, HBV or HCV active infection\n* Grade \\>3 CTCAE (v. 6) clinically relevant (as per local investigator) adverse events at the time of enrolment\n* Prior treatment for myelodysplastic syndrome (MDS) with Venetoclax or hypomethylating agents (decitabine, azacitidine).\n* Any prior AML therapies (except for emergency treatment with hydroxyurea or cytarabine for hyperleukocytosis) Note: Subjects who undergo diagnostic workup for APL and treatment with all-trans retinoic acid, but who are found not to have APL, are eligible (treatment with all-trans retinoic acid must be discontinued before starting induction chemotherapy).\n* Any prior treatment with a FLT3 inhibitor\n* Serious organ dysfunction as left ventricular ejection fraction \\\u003C40%, FEV1, FVC, DLCO (diffusion capacity) \\\u003C40% of predicted\n* Cardiovascular disability status of New York Heart Association class ≥ 2\n* Congenital long QT syndrome or QT Interval Corrected Using Fridericia's Formula (QTcF) \\>450 msec Note: repeat electrocardiograms after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria. In cases where QTcF \\>450 msec is considered to be falsely increased due to inaccurate automated reading and not clinically significant (e.g. due to bundle branch block), patients are still eligible if cardiologist reviews and documents that QTcF is ≤ 450 msec when manually measured.\n* Participant with a prior or concurrent malignancy or autoimmune disease requiring immunosuppressive therapy.\n\nNote: diseases whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the 2467 medical monitor and the study coordinator.\n\n* Consumed strong or moderate inducers of Cytochrome P450, family 3, subfamily A (CYP3A) or p-glycoprotein within 14 days of study enrolment or requiring treatment with such a medication during the trial.\n* Inability to swallow and\u002For any gastrointestinal disorders, malabsorption or other abnormalities that would interfere with absorption of the oral study drug.\n* Other life-threatening concurrent disease.","75 Years",{"count":297,"type":21},230,[86,24],"This international, multicenter, randomized (1:1), open-label phase II\u002FIII trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard \"7+3\" induction plus a FLT3inhibitor (quizartinib or midostaurin) (control arm) in newly diagnosed FLT3-ITD mutated AML patients eligible for intensive chemotherapy.",[301],"AML (Acute Myeloid Leukemia)","2026-02-20",{"date":304,"type":37},"2026-02-23",{"date":306,"type":21},"2026-12-01",{"date":308,"type":21},"2032-02-01",{"name":43,"class":44},{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":317,"targetDuration":319,"studyType":57,"phases":4,"briefSummary":320,"conditions":321,"keywords":335,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},"100459206","observational-study-for-assessing-treatment-and-outcome-of-patients-with-primary-brain-tumours-using-cimpact-now-and-2021-who-classification-100459206","NCT05259605","Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification","Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Diagnosed According to cIMPACT-NOW Recommendations and the 2021 WHO Classification","* Age ≥ legal age of consent\n* Newly diagnosed or recurrent primary brain tumours within one of the 17 cohorts of interest\n* Archival tumour tissue from primary tumour available at the site. Representative tissue from first surgery is preferred, but tissue from surgery for recurrence is allowed. Exception: only tissue from first surgery is allowed for Cohort 16.\n* Available MRI\u002FCT scans from primary brain tumour at initial diagnosis\n* Patient's consent\n\nDeceased patient:\n\nThe clinical data and\u002For biological material and\u002For CT\u002FMRI\u002FPET images can be accessed and used if at least one of the following three conditions is met:\n\n* The patient agreed beforehand in his\u002Fher lifetime to a further use of his\u002Fher data and\u002For biological material and\u002For CT\u002FMRI\u002FPET images, or,\n* There is consent of a relative to use data and\u002For biological material and\u002For CT\u002FMRI\u002FPET images of the deceased patient, or,\n* There is a reference to a corresponding legal declaration covering the exemption in case of the impossibility or disproportion of getting access to an informed consent (e.g., causing strain on relatives of deceased patients).\n\nAdditionally, in all cases the following three points need to be fulfilled:\n\n* No documentation of previous objection of the patient to the (re-)use of their data, biological material, CT\u002FMR\u002FPET images for research purposes\n* A notification to an ethics committee for the re-use of these data, biological material and CT\u002FMRI\u002FPET images\n* Any other national requirements are fulfilled, if applicable",{"count":318,"type":21},1650,"10 Years","Every new classification depends on its prognostic power and on the type of treatment given. With the rapid evolution of diagnostic methods and the advance in new treatments, there is much less reliable information available on how patients with newly defined brain tumour entities should be treated and what to expect from the current treatments.\n\nThe goal is to determine whether the new 2021 WHO classification, based on cIMPACT-NOW recommendations, results in more homogeneous patient groups than the old 2016 classification. Furthermore, it will help derive provisional guidelines on how patients with these newly defined tumour entities are best treated. These recommendations will be based on the experience of EORTC investigators with chosen treatments and their experience as reported in this data collection report.",[322,323,324,325,326,327,328,329,330,331,332,333,334],"Glioma","Glioneuronal Tumor","Choroid Plexus Tumor","Pineal Tumors","Germ Cell Tumor","Tumor of the Sellar Region","Diffuse Midline Glioma, H3 K27M-Mutant","Ependymoma","Embryonal Tumor","Pineal Tumor","Hemangiopericytoma","Hemangioblastoma","Melanocytic Tumor of CNS",[336,337,338,339,340,341,342],"Rare primary brain tumor","2021 WHO Classification","molecular diagnosis","Gliomas","Choroid plexus tumors","Embryonal tumors","Pineal tumors","2025-12-11",{"date":345,"type":37},"2025-12-17",{"date":347,"type":37},"2023-03-21",{"date":349,"type":21},"2038-07-29",{"name":43,"class":44},42,{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":359,"minAge":18,"maxAge":165,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":372,"leadSponsor":374,"locationsCount":375},"100514152","phase-3-intermittent-androgen-deprivation-therapy-in-the-era-of-ar-pathway-inhibitors-100514152","NCT05974774","Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors","Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors; a Phase 3 Pragmatic Randomized Trial.","Inclusion Criteria:\n\n* Patient treated with ADT and an ARPI for mHNPC for 6-12 months and presenting with a PSA ≤ 0.2 ng\u002FmL Note: Patient may have received docetaxel and radiotherapy of the prostate and metastases Note: Patients with synchronous or metachronous metastases, high volume\u002Frisk or low volume\u002Frisk who fulfil the criteria can be included.\n* Before patient 's enrolment, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* Patients with M1a on modern imaging technique (PET-Choline or -PSMA or Whole Body MRI) for whom radiation therapy and 2-3 years of hormone therapy is planned\n* Patients who underwent or will undergo a bilateral orchiectomy\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment for this trial\n* Patients who have received a systemic anti-prostate cancer treatment not approved by EMA together with MAB or a radical prostatectomy for M1 disease\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial","MALE",{"count":361,"type":21},1600,[24],"This study addresses the global topic of treatment optimization, i.e. achieving similar benefit while reducing the duration of treatment, hence hoping to decrease the burden of side-effects, improve quality-of life and reduce resource utilization.\n\nThe primary goal of de-escalation is to investigate whether using an intermittent regime results in a similar OS to continuous treatment.",[365],"Prostate Cancer",[367],"Metastatic hormone-naïve prostate cancer","2025-09-15",{"date":370,"type":37},"2025-09-19",{"date":203,"type":37},{"date":373,"type":21},"2039-06-01",{"name":43,"class":44},9,{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":387,"conditions":388,"keywords":393,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":45},"100551659","oligocare-twics-trials-within-cohorts-trial-comparing-acute-toxicity-in-single-fraction-vs-multiple-fraction-sbrt-for-metastasis-directed-treatment-sprint-100551659","NCT06462963","OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)","SPRINT","Inclusion Criteria:\n\n* Patient is part of the RP1822-OligoCare. As in OligoCare, ALL active cancer lesions (loco-regional primary and all oligometastases) were or will be treated with radical intent (surgery or radiotherapy).\n* All lesions that will be treated with radical radiotherapy have to be amenable to single-fraction SBRT. Concurrent systemic treatment is allowed.\n* Written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations. Patients will be consented in a step-wise approach.\n\nStep 1 \\[both control and experimental arms\\]: patients will need to consent to be included and evaluated in E²-RADIatE (that includes the non-interventional OligoCare prospective registry cohort) and to potentially be randomized to future sub-studies for which they are eligible; no further consent will be sought if they are randomized to the SoC (control) arm; Step 2 \\[experimental arm only\\]: if eligible for the current sub-study and randomized to receive single-fraction SBRT, patients will need to consent to receiving the experimental treatment.\n\nExclusion Criteria:\n\nAll targeted lesion judged by the treating physician to be associated with risks for severe toxicity following single-fraction SBRT. The following lesions are systematically excluded:\n\n* Pulmonary metastases within 1 cm of proximal bronchial tree, esophagus or brachial plexus\n* Metastases within \\\u003C 5 mm of any hollow GI structure: esophagus, stomach, small bowel, large bowel\n* Metastases within \\\u003C 5 mm of the spinal cord, the cauda equina or the brachial plexus\n* Metastases \\> 5 cm in largest diameter.",{"count":384,"type":21},302,[386],"NA","The goal of this clinical trial is to evaluate single-fraction metastases-directed SBRT in the broader radiation oncology community and to compare its safety and efficacy profile with the current Standard of Care (SoC) of multiple-fraction SBRT in patients with oligometastatic disease of primary breast, prostate, NSCLC and colorectal cancer having all lesions that will be treated with radical radiotherapy amenable to single-fraction SBRT.\n\nThe main question\u002Fhypothesis this clinical trial aims to answer is:\n\n\\- Single-fraction SBRT has comparable outcomes as those obtained with multiple fraction SBRT, both in terms of safety and efficacy.\n\nPatients from the OligoCare cohort will be randomized to receive either single-fraction SBRT or the current SoC of multiple-fraction SBRT.",[389,365,390,391,392],"Breast Cancer","NSCLC","Colorectal Cancer","Oligometastatic Disease",[394,395,396],"radiotherapy","SBRT","TwiCs","2025-07-30",{"date":399,"type":37},"2025-08-01",{"date":401,"type":37},"2025-04-15",{"date":403,"type":21},"2029-02-15",{"name":43,"class":44},{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":424,"leadSponsor":426,"locationsCount":4},"100591256","phase-1-peri-operative-treatment-of-resectable-gastroesophageal-cancer-using-bemarituzumab-bema-plus-perioperative-treatment-100591256","NCT06978062","Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment","An Open-label, Multi-centre, Phase 1b Safety and Feasibility Study for the Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment (NeoBEMA)","NeoBEMA","Inclusion Criteria:\n\n* Signed screening informed consent\n* Age ≥ 18 years\n* Availability of a diagnostic tumour sample for central evaluation (FFPE block or minimum 10 slides).\n* Histologically proven, previously untreated, locally advanced, resectable gastric\u002FGEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0. Note: if the results of the staging laparoscopy are pending at this stage it is acceptable to include the patients in this step, in the interest of patient time-to-treatment.\n* Planned peri-operative treatment with FLOT chemotherapy and surgically assessed feasible R0 resection\n* Centrally confirmed FGFR2b overexpression as defined by ≥10% tumour cells with 2+\u002F3+ FGFR2b staining by immunohistochemistry (IHC)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Previously untreated, locally advanced, histologically confirmed, resectable gastric\u002FGEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0 by radiological and surgical staging\n* Adequate hematologic and organ function\n\nExclusion Criteria:\n\n* Prior anticancer treatment for the disease under investigation\n* History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmologic corticosteroids\n* Evidence of any ongoing ophthalmologic abnormalities or symptoms that are recent (within 4weeks) or actively progressing\n* Unwillingness to avoid the use of contact lenses during study treatment and follow-up period of at least 100 days after end of treatment.\n* Evidence of, or recent (within 6 months) history of, corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer. Recent (within 6 months) corneal surgery or ophthalmologic laser treatment\n* History of solid organ transplantation\n* History of interstitial lung disease\n* Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study\n* Patients on immunosuppressive therapy or having immune system disorders, including auto-immune diseases. Concurrent steroid use of not more than an equivalent of 10 mg\u002Fday prednisolone is allowed. Inhaled, intranasal, intraocular, and\u002For joint injections of corticosteroids are allowed.",{"count":414,"type":21},27,[416],"PHASE1","This is an open-label,multi-centre, phase 1b safety and feasibility study aiming to assess the safey and feasibility of bemarituzumab plus chemiotherapy (FLOT) for the peri-operative treatment of resectable gastroesophageal cancer. Following this neo-adjuvant part, patients should undergo surgery. Following surgery, patients will receive FLOT chemotherapy in combination with bemarituzumab. Imaging will be performed every 3 months for the first 2 years and thereafter every 6 months as per standard of care.",[419],"GastroEsophageal Cancer","2025-06-02",{"date":422,"type":37},"2025-06-05",{"date":302,"type":21},{"date":425,"type":21},"2029-09-28",{"name":43,"class":44},{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":22,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":4},"100592179","radiotherapy-for-bcg-unresponsive-non-muscle-invasive-carcinoma-in-situ-cis-bladder-cancer-an-open-label-single-arm-multicentre-phase-2-study-100592179","NCT06990061","Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, Multicentre, Phase 2 Study","Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer","BRACE","Inclusion Criteria:\n\n* Histologically confirmed, BCG-unresponsive, high-risk non-muscle-invasive bladder cancer (according to EAU guidelines \\[2\\] (see table 1)) °of predominantly (\\>50%) urothelial histology who were ineligible for or declined to undergo radical cystectomy.\n\n  * Patients with carcinoma in situ with or without high-grade Ta or T1 are allowed if patients with concomitant Ta and T1 tumors have undergone complete TURBT, defined as per standard of care as a visually complete resection. A second TURBT is recommended but not required for patients with T1 tumor.\n  * The most recent cystoscopy or TURBT must have been done within 12 weeks before study enrolment.\n  * Eastern Cooperative Oncology Group performance status of 0-2\n  * Adequate organ function (at minimum WBC \\> 4.0 × 109\u002FL; platelets \\> 100 × 109\u002FL; GFR \\> 25mL\u002Fmin)\n  * 18 years or older\n  * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hrs prior to the first day of radiation.\n  * Patients of childbearing \u002F reproductive potential should use adequate birth control measures during the study treatment period and for at least 4 weeks after the last day of radiation. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include:\n  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)\n  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n  * Intrauterine device (IUD)\n  * Intrauterine hormone-releasing system (IUS)\n  * Bilateral tubal occlusion\n  * Vasectomized partner\n  * Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)\n  * Before patient 's enrolment, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Evidence of muscle invasive or metastatic urothelial carcinoma\n* Evidence of upper urinary tract carcinoma\n* Poor bladder function (IPSS \\>16)\n* Hydronephrosis due to tumour in the presence of T1 disease\n* Patients on current systemic therapy for bladder cancer\n* Patients who have received pelvic external beam radiotherapy within the previous 5 years\n* Any known contraindications or allergies to the use of local standard of care radiosensitiser, if applicable",{"count":436,"type":21},50,[386],"Standard treatment for patients with high-risk NMIBC (high-grade Ta, CIS, or any T1) consists of intravesical Bacillus Calmette-Guerin (BCG) immunotherapy. However, BCG, even administered optimally, does not provide absolute protection and BCG failure is generally considered recurrence or progression during therapy.\n\nPatients who are BCG-unresponsive have a 20-40% risk for progression to muscle-invasive bladder cancer within 5 years, and a 50% risk of developing metastatic disease. For these patients, radical cystectomy with pelvic lymph node dissection and urinary diversion is the standard of care. However, many patients are unable to undergo radical cystectomy because of poor performance status and co-morbidities or decline to undergo surgery.\n\nAlthough, several phase II studies have shown promising results, none of the drugs are presently available in Europe. An alternative approach is to investigate a possible role for radiotherapy in good prognosis bladder cancer patients. As there is little existing data in NMIBC, the example of bladder preservation in MIBC will be used for guidance.\n\nWe aim to evaluate the use of radiotherapy in patients with high-grade non-muscle-invasive bladder cancer who have BCG failure in a single-arm design as per FDA guidelines for this setting. The primary objective is to demonstrate that complete response to treatment 6 months post radiotherapy is seen in more than 30% of patients with BCG-unresponsive, non-muscle invasive carcinoma in situ bladder cancer, unfit or unwilling to undergo radical cystectomy.\n\nPatients with BCG unresponsive non-muscle-invasive bladder cancer according to the EAU guidelines will be treated 20 fractions of 2.75 Gy over 4 weeks with the use of radiosensitisers as per local guidelines. Cystoscopy and urine cytology assessments will be performed at 3 and 6 months from the start of radiotherapy. If either assessment is positive, bladder biopsies or TURBT are required. At the 6-month timepoint, biopsy or TURBT is mandatory. Disease assessments beyond 6 months will be at the treating urologist's discretion.",[440],"Non-Muscle Invasive Bladder Cancer","2025-05-19",{"date":443,"type":37},"2025-05-25",{"date":445,"type":21},"2025-12-01",{"date":447,"type":21},"2031-09-18",{"name":43,"class":44},{"id":450,"slug":451,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":456,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":469},"100348569","e-radiate-eortc-estro-radiotherapy-infrastructure-for-europe-100348569","NCT03818503","E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe","E²-RADIatE","Inclusion Criteria:\n\n* Pathologically confirmed cancer.\n* Written informed consent for E²-RADIatE according to applicable legal and ethical requirements\n* Planned use of radiotherapy\n* Eligibility of the patient confirmed for at least one cohort confirmed\n* Patients of 12 years and older",{"count":457,"type":21},2000,"The primary objective is the collection of real-world data of cancer patients treated with radiotherapy, to support radiotherapy research and to provide evidence of the role of radiation oncology in a multidisciplinary approach. This is an open ended prospective non-interventional non-therapeutic multi-cohort study.",[460],"Cancer","2025-03-20",{"date":463,"type":37},"2025-03-21",{"date":465,"type":37},"2019-06-24",{"date":467,"type":21},"2026-04-30",{"name":43,"class":44},77,{"id":471,"slug":472,"hasResults":11,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":479,"briefSummary":480,"conditions":481,"keywords":488,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":4},"100547394","phase-3-improvement-of-quality-of-life-through-supportive-treatments-for-hormone-therapy---related-symptoms-in-patients-with-early-breast-cancer-100547394","NCT06407401","Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer","Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer; A Pragmatic Randomized Controlled Trial","Inclusion criteria:\n\n* Female (both pre- and postmenopausal) or male patients\n* Age ≥18 years\n* Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI ) for ER positive HER2 negative breast cancer stages I-III\n* Patients must have received at least 3 months and up to 3 years of ET and planned to continue ET during the study conduction\n* Present endocrine therapy related MSK pain (arthralgia and\u002For bone pain and\u002For myalgias), evaluated by the treating clinician as at least grade 2 CTCAE V5.0 for, at least, 4 weeks before enrolment, at the time of the clinic visit:\n\n  * Grade 2: moderate pain; limiting instrumental activities daily living (ADL)\n  * Grade 3: severe pain; limiting activities self-care ADL\n* Previous chemotherapy is allowed if completed at least 3 months before enrolment\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Adequate organ function\n* Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module)\n* Before patient registration, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the first dose of study treatment.\n\nNote: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, except for those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.\n\n* Patients of childbearing \u002F reproductive potential must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation.\n* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment.\n\nExclusion criteria:\n\n* Current history of moderate\u002Fsevere depression and\u002For anxiety, both defined as grade≥2 CTCAE V5.0\n* History of suicide-related events\n* Current use of diuretics, antidepressants and\u002For phytoestrogens\n* Current use of prescribed or natural medicines with known interactions with furosemide and\u002For duloxetine\n* Contraindications to duloxetine:\n\n  * Severe renal impairment (creatinine clearance \\< 30 mL\u002Fmin)\n  * Uncontrolled hypertension\n  * Hepatic impairment Child Pugh Class B or C\n* Contraindications to furosemide:\n\n  * Symptomatic hypotension, hypovolemia, or dehydration\n  * Severe renal impairment (creatinine clearance \\< 30 mL\u002Fmin)\n  * Severe hypokalaemia and\u002For severe hyponatremia\n  * Addison's disease\n  * Porphyria\n* Uncontrolled intercurrent illness, including psychiatric conditions, chronic alcoholism, and drug addiction, that would, in the judgment of the investigator, limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.\n* Participation in another interventional study with drugs.",{"count":478,"type":21},399,[24],"This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+\u002FHER2- early breast cancer with joint, muscle and\u002For bone pain caused by the endocrine therapy.\n\nThe purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and\u002For bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).",[482,275,483,484,485,486,487],"ER+ Breast Cancer","Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III","Drug-Related Side Effects and Adverse Reactions","Musculoskeletal Pain",[489],"Quality of Life","2024-11-04",{"date":492,"type":37},"2024-11-05",{"date":494,"type":21},"2024-12",{"date":496,"type":21},"2028-11-30",{"name":43,"class":44},{"id":499,"slug":500,"hasResults":11,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":22,"phases":507,"briefSummary":508,"conditions":509,"keywords":525,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":536},"100400786","stereotactic-body-radiotherapy-in-patients-with-rare-oligometastatic-cancers-oligorare-100400786","NCT04498767","Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)","Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial","OligoRARE","Inclusion Criteria:\n\n* Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.\n* Controlled primary tumour, defined as:\n* at least 3 months since original tumour treated definitively, with no progression at primary site\n* Total number of oligometastases of 1-5 including:\n* Brain metastases amenable to radiosurgery or fractionated stereotactic radiotherapy patient who had neurosurgical resection before trial inclusion are allowed and resected brain metastases count to the total number of oligometastases\n* All sites of disease can be safely treated based on the judgement of an experienced radiation oncologist\n* ECOG score 0-2\n* Life expectancy \\> 6 months\n* Age 18 or older\n* Before patient randomization, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Primary cancer of prostate, breast, lung or colorectal\n* Serious medical comorbidities precluding radiotherapy:\n* These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.\n* For patients with liver metastases, moderate\u002Fsevere liver dysfunction (Child Pugh B or C)\n* Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated previously with radiation, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in the RTQA Guidelines. All such cases should be discussed with one of the study coordinators\n* Brain metastases only, without extra-cerebral metastases\n* Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal carcinomatosis\n* Maximum size of 6 cm for lesions outside the brain, except:\n* Bone metastases over 5 cm may be included, if in the opinion of the local radiation oncologist it can be treated safely (e.g. rib, scapula, pelvis)\n* Clinical or radiologic evidence of symptomatic spinal cord compression. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 3 metastases.\n* Metastatic disease that invades any of the following: GI tract (including oesophagus, stomach, small or large bowel), mesenteric lymph nodes, or disseminated skin metastases and lymphangiosis\n* Pregnant or breast feeding women\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial",{"count":190,"type":21},[386],"This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers.\n\nPatients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease.\n\nThe primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.",[510,511,512,513,514,515,516,517,518,519,520,521,522,523,524],"Gynecologic Cancer","Skin Cancer","Head and Neck Cancer","Sarcoma","Renal Cancer","Bladder Cancer","Upper Urinary Tract Carcinoma","Pancreatic Cancer","Hepatobiliary Cancer","Gastric Cancer","Small Bowel Cancer","Esophageal Cancer","Melanoma","Colon Cancer","Oligometastasis",[526,527,395],"oligometastatic cancer","Stereotactic body radiotherapy","2024-08-23",{"date":530,"type":37},"2024-08-26",{"date":532,"type":37},"2021-06-10",{"date":534,"type":21},"2030-02-01",{"name":43,"class":44},13,{"id":538,"slug":539,"hasResults":11,"nctId":540,"briefTitle":432,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":11,"sex":359,"minAge":18,"maxAge":165,"enrollmentInfo":543,"targetDuration":4,"studyType":22,"phases":544,"briefSummary":545,"conditions":546,"keywords":547,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":4},"100539940","phase-2-radiotherapy-for-bcg-unresponsive-non-muscle-invasive-carcinoma-in-situ-cis-bladder-cancer-100539940","NCT06310369","Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, Multicenter, Phase 2 Study","Inclusion Criteria:\n\n* 18 years or older with histologically confirmed, BCG-unresponsive, high-risk non-muscle-invasive bladder cancer of predominantly (\\>50%) urothelial histology who were ineligible for or declined to undergo radical cystectomy\n* Patients with carcinoma in situ with or without high-grade Ta or T1\n* Eastern Cooperative Oncology Group performance status of 0-2, and adequate organ function\n* Patients with concomitant Ta and T1 tumours must have undergone complete TURBT, defined as per standard of care as a visually complete resection (residual carcinoma in situ, which is traditionally not amenable to complete transurethral resection is acceptable), and the most recent cystoscopy or TURBT must have been done within 12 weeks before study initiation. Presence of detrusor muscle on pathology samples is required to ensure sample adequacy. A second TURBT is recommended but not required for patients with T1 tumours. The use of either white-light cystoscopy or blue-light cystoscopy is permitted, but the same technique has to be used in a patient throughout the trial\n* Definition of BCG unresponsive non-muscle-invasive bladder cancer according to the European Association of Urology (EAU) guidelines\n\nExclusion Criteria:\n\n* Evidence of upper urinary tract carcinoma\n* Hydronephrosis due to tumour in the presence of T1 disease\n* Patients on current systemic therapy for bladder cancer\n* Patients who have received pelvic external beam radiotherapy within the previous 5 years",{"count":436,"type":21},[86],"The investigators aim to investigate a possible role for radiotherapy in good prognosis bladder cancer patients has been identified as a possible alternative to cystectomy, especially for patients non-eligible for surgery but has yet to be fully explored.",[515],[548],"NMIBC","2024-07-18",{"date":551,"type":37},"2024-07-22",{"date":553,"type":21},"2025-03-01",{"date":555,"type":21},"2030-03-01",{"name":43,"class":44},{"id":558,"slug":559,"hasResults":11,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":567,"briefSummary":568,"conditions":569,"keywords":571,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":536},"100372336","phase-2-anti-ccr4-monoclonal-antibody-mogamulizumab-and-total-skin-electron-beam-therapy-tseb-in-patients-with-stage-ib-iib-cutaneous-t-cell-lymphoma-100372336","NCT04128072","Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma","MOGAT: Open-Label, Phase II, Multi-Centre, Study of Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma","MOGAT","Inclusion Criteria:\n\n* Diagnosis of MF stage IB, IIA or IIB at registration, and MF stage should have never met criteria for stage IIIA or higher.\n* Subjects who have failed (refractory or relapsed) at least one prior course of systemic therapy.\n* All clinically significant toxic effects of prior cancer therapy to grade ≤ 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE, v.5.0), excluding the specifications required in the criteria 'Adequate haematological and organ function' below\n* Males and female subjects ≥ 18 years\n* WHO performance status 0-1\n* Adequate haematological and organ function:\n* absolute neutrophil count (ANC) ≥ 1.0 × 109\u002FL\n* platelets ≥ 75 × 109\u002FL (≥ 75,000\u002Fmm3)\n* bilirubin ≤ 1.5 × upper limit of normal (ULN) except for subjects with Gilbert's syndrome;\n* aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN\n* serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance \\> 50 mL\u002Fmin using the Cockcroft-Gault formula\n* Subjects previously treated with anti-CD4 antibody or alemtuzumab are eligible provided a washout period ≥ 3 months and CD4+ cell counts ≥ 200\u002Fmm3\n* Clinically normal cardiac function based on 12-lead ECG and above the institutional lower limit of normal for left ventricular ejection fraction assessed either by multi-gated acquisition scan or cardiac ultrasound\n* Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to the first dose of study treatment\n* WOCBP must agree to use effective contraception, defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice through abstinence from sexual intercourse during the study and for 6 months after the last dose.\n* Male subjects and their female partners of child bearing potential must be willing to use an appropriate method of contraception defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice through abstinence from sexual intercourse (periodic abstinence, e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) during the study and for 6 months after the last dose.\n* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment\n* Before patient registration, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* Prior treatment with mogamulizumab, or any other anti-CCR4\n* Prior TSEB\n* Patients who received localised radiotherapy within 2 weeks prior to registration\n* Patients who received any systemic therapy for MF within 4 weeks prior to registration.\n\nNote: In case of rapid progression, if patient has recovered from all toxicities AND last dose occurred more than 5 half lives of the drug\u002Ftreatment used, patient could be allowed to start earlier after consultation with medical monitor\n\n* History of other malignancy in the past 5 years with the exception of treated carcinoma in situ of the cervix, localized prostate cancer with PSA \\\u003C0.1, in-situ melanoma, and non-melanoma skin cancer\n* History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins\n* Known hypersensitivity to CHO cell products or any component of the mogamulizumab formulation (see section 6.1.1)\n* Significant uncontrolled intercurrent illness including, but not limited to:\n* uncontrolled infection requiring antibiotics;\n* clinically significant cardiac disease (class III or IV of the New York Heart Association \\[NYHA\\] classification);\n* unstable angina pectoris;\n* angioplasty, stenting, or myocardial infarction within 6 months;\n* clinically significant cardiac arrhythmia\n* Have active sign of herpes zoster\n* Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.\n* Patients with eczema, psoriasis, lichen simplex chronicus, with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n* Rash must cover \\\u003C10% of body surface area\n* Disease is well controlled at baseline and requires stable use of low to mild potency topical corticosteroids for at least 4 weeks.\n* No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 4 months.\n* Immunomodulatory drugs or high-dose systemic steroids for concomitant or intercurrent conditions other than T-cell lymphoma within 7 days of registration.\n\nHowever, stable dose of a low dose systemic systemic corticosteroid (≤10 mg prednisone equivalent per day) or stable dose of a low potency topical corticosteroid for at least 4 weeks prior to the registration is permitted. Subjects may receive intra-articular, intraocular, inhalation or nasal corticosteroids. Initiation of treatment with corticosteroids or increase in dose while on study is not permitted except for the treatment of adverse events.\n\n* Patients who are planned to receive stem cell transplantation\n* Has a known history of Human T-lymphotropic virus 1 (HTLV-1), or human immunodeficiency virus (HIV) (test to be performed within 21 days of registration if allowed by local legislation)\n* Has known active Hepatitis B or Hepatitis C\n* Note: patient will be eligible if:\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening . The HBV DNA test will be performed only for patients who have a positive total HBcAb test.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial",{"count":566,"type":21},43,[86],"Cutaneous T-Cell Lymphoma (CTCL) has a chronic, relapsing course with patients undergoing multiple, consecutive therapies. Treatment aims at the clearance of skin disease, minimization of recurrence, prevention of disease progression and preservation of quality of life.\n\nThe treatment of CTCL is primarily determined by the disease extent. Prolonged complete remissions have been obtained with skin-directed therapies in early stage Mycosis fungoides (MF) (IA-IIA), whereas advanced stages CTCL (IIB-IVB) are often refractory to treatment and, thus, have an unfavorable prognosis.\n\nCurrently, there is no standard treatment option for CTCL, especially for advanced stages, and the optimal treatment sequence is still debated with a large variability in the therapeutic approach across countries. Patients with advanced-stage disease or refractory cutaneous CTCL should be treated with systemic therapies and, whenever possible, should be offered to participate in clinical trials. Currently, there is a urgent call for new treatments in CTCL with higher response rate and prolonged time to progression;\n\nIn this study, we propose a very innovative treatment schedule in which mogamulizumab is used before Total Skin Electron Beam therapy (TSEB) for systemic disease control and as a maintenance treatment after skin-directed therapy. We hypothesize that our regimen will show a more manageable toxicity profile than a combination treatment and allow for a long-term mogamulizumab administration.",[570],"Stage IB-IIB Cutaneous T-Cell Lymphoma",[572,573,574],"Cutaneous T-Cell Lymphoma","Mogamulizumab","Total Skin Electron Beam therapy","2024-04-04",{"date":577,"type":37},"2024-04-05",{"date":579,"type":37},"2023-03-07",{"date":581,"type":21},"2027-01",{"name":43,"class":44},{"id":584,"slug":585,"hasResults":11,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":22,"phases":592,"briefSummary":593,"conditions":594,"keywords":597,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":609},"100423161","prophylactic-cerebral-irradiation-or-active-magnetic-resonance-imaging-surveillance-in-small-cell-lung-cancer-patients-primalung-study-100423161","NCT04790253","PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)","PRIMALung","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically\u002Fcytologically proven diagnosis of SCLC\n* Limited and extensive stage\n* LS SCLC: Stage I-III (T any, N any, M0, according to UICC TNM staging v8.0) that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumour\u002Fnodal volume that is too large to be encompassed in a tolerable radiation plan.\n* ES SCLC: Stage IV (T any, N any, M 1a\u002Fb), or T3-4 due to multiple lung nodules that are too extensive or have tumour\u002Fnodal volume that is too large to be encompassed in a tolerable radiation plan.\n* Completed standard therapy prior to randomization:\n* For patients with LS-SCLC, this includes a combination of 4-6 cycles of platinum-based doublet chemotherapy and either definitive thoracic radiotherapy (including SBRT for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician, but is not mandated.\n* For patients with ES-SCLC, this includes 4-6 cycles of platinum-based doublet chemotherapy either with or without thoracic radiotherapy\n\n  o Immunotherapy concurrent with and\u002For adjuvant to standard therapy is allowed at the discretion of the treating physician.\n* Absence of progressive disease after completed standard therapy on systemic imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of Chest\u002FAbdomen\u002FPelvis and brain MRI), 28 days before randomization.\n* Absence of brain metastases or leptomeningeal disease after completed standard therapy on systemic imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of Chest\u002FAbdomen\u002FPelvis and brain MRI), within 28 days before randomization.\n* Interval from day 1 of last cycle of chemotherapy to randomization of ≤8 weeks\n* ECOG PS ≤ 2\n* Estimated creatinine clearance ≥ 30 mL\u002Fmin as calculated using the MDRD formula\n* Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization.\n\nNote: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression or other reasons.\n\n* Patients Women of childbearing \u002F reproductive potential should use adequate birth control measures, as defined by the investigator, during the entire period of the radiotherapy treatment study participation and for at least 30 days after the last dose of radiotherapy. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:\n* Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)\n* Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n* Intrauterine device (IUD)\n* Intrauterine hormone-releasing system (IUS)\n* Bilateral tubal occlusion\n* Vasectomized partner\n* Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)\n* Female subjects who are breast feeding should discontinue nursing prior to the first dose of radiotherapy and during the entire period of the radiotherapy treatmentuntil 30 days after the administration of the last dose of radiotherapy.\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Before patient registration\u002Frandomization, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Prior radiotherapy to the brain or whole brain radiotherapy. Note: Patients who have undergone prior stereotactic radiosurgery for benign tumours or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis. Discussion with EORTC Headquarters is mandatory, before the randomization.\n* Known contraindication to imaging tracer or any product of contrast media, such as allergy or insufficient renal function. Known contraindication to MRI, such as implanted metal devices or foreign bodies.\n* Other active hematologic or solid tumour malignancy requiring current active treatment.\n* Any unresolved toxicities from prior therapy (e.g., chemotherapy, radiotherapy) greater than CTCAE grade 2 (according to CTCAE v5.0) at the time of randomization.\n* Patient with severe active comorbidities, defined as follows:\n* Unstable angina and\u002For congestive heart failure requiring hospitalization within 6 months prior to randomization\n* Transmural myocardial infarction within 6 months prior to randomization\n* Acute infection requiring treatment at the time of randomization\n* Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization\n* Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease\n* HIV positive with CD4 count \\\u003C 200 cells\u002Fmicroliter. Note: patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells\u002Fmicroliter within 16 weeks prior to randomization.\n* Any severe comorbidity that in the opinion of the Investigator might hamper the participation to the study and\u002For the treatment administration.\n* Severe neurological (including dementia and epilepsy) or psychiatric disorder requiring active treatment.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial",{"count":591,"type":21},600,[386],"In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.",[595,596],"Limited Stage Small Cell Lung Cancer","Extensive-stage Small-cell Lung Cancer",[598,599,600],"Prophylactic cerebral Irradiation","small cell lung cancer","PCI","2023-11-02",{"date":603,"type":37},"2023-11-03",{"date":605,"type":37},"2022-10-27",{"date":607,"type":21},"2028-04",{"name":43,"class":44},41,""]