[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oligometastatic-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oligometastatic-disease":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,44,69,101,129,154,180,205,233,259,283,315,341,367,393,418,440,463,490,515,545,582,608,642,677],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100499528","single-vs-multiple-fraction-trial-of-stereotactic-ablative-radiotherapy-for-comprehensive-treatment-of-oligometastasesprogression-100499528",false,"NCT05784428","Single vs. Multiple Fraction Trial of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastases\u002FProgression","Single vs. Multiple Fraction Non-Inferiority Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligo-metastases\u002FProgression: SIMPLIFY-SABR-COMET","Inclusion Criteria:\n\n* 1-5 current oligometastatic or oligo-progressive lesions\n* Age 18 years or older\n* Able to provide informed consent\n* Able to complete electronic entry of patient reported outcomes and questionnaires independently or with assistance from a caregiver\u002Ffamily\u002Ffriend\u002Fresearch staff using electronic methods after providing consent to email use.\n* Life expectancy \\> 6 months\n* Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Controlled primary tumor: defined as at least 3 months since original tumor treated radically, with no progression at primary site (can be considered controlled if no evidence of the primary tumour on imaging \\[e.g. primary unknown\\])\n* A history and physical examination, including ECOG performance status, performed within 6 weeks prior to enrollment\n* Patient has had a CT chest, abdomen and pelvis or PET-CT within 10 weeks prior to enrollment, and within 13 weeks prior to treatment\n* Patient has had a nuclear bone scan (if no positron emission tomography-computed tomography \\[PET-CT\\]) within 10 weeks prior to enrollment, and within 13 weeks prior to treatment\n* Patient has had CT or MRI brain imaging if primary has a propensity for central nervous system metastases (if deemed appropriate by the treating investigator) within 10 weeks prior to enrollment, and within 13 weeks prior to treatment.\n* For patients with known spine metastases, patient has had MRI spine imaging within 10 weeks prior to enrollment, and with 13 weeks prior to treatment.\n* If solitary lung nodule for which biopsy is unsuccessful or not possible, patient has had an FDG (fluorodeoxyglucose) PET scan or CT (chest, abdomen, pelvis) and bone scan within 10 weeks prior to enrollment, and within 13 weeks prior to treatment\n* If colorectal primary with rising Carcinoembryonic antigen (CEA), but equivocal imaging, patient has had an FDG PET scan within 10 weeks prior to enrollment, and within 13 weeks prior to treatment\n* Patient is judged able to:\n\n  * Maintain a stable position during therapy\n  * Tolerate immobilization device(s) that may be required to deliver SABR safely\n* Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date\n\nExclusion Criteria:\n\n* Uncontrolled concurrent malignant cancer\n* Lesion in femoral bone requiring surgical fixation\n* No chemotherapy agents (cytotoxic, or molecularly targeted agents) will be used within the period of time commencing 1 week prior to radiation, lasting until 1 week after the last fraction. See section 5.3.3 regarding this criterion.\n* Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, and connective tissue disorders such as lupus or scleroderma.\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 with radiation previously, similar biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases should be discussed with the local and study principal investigators (PIs).\n* Current malignant pleural effusion\n* Liver metastases located in the \"Biliary no fly zone\" defined for this trial as common biliary track, cystic duct and distal branches (1 cm) + 5 mm.\n* Inability to treat all sites of oligometastatic or oligoprogressive disease\n* Presence of brain metastases as the sole site of disease\n* Maximum size of 5 cm for lesions outside the brain, except:\n\n  * Bone metastases over 5 cm may be included, if in the opinion of the local PI it can be treated safely (e.g. rib, scapula, pelvis)\n* Any brain metastasis \\> 3.5 cm in size or a total volume of brain metastases greater than 30 cc is excluded\n* Clinical or radiologic evidence of spinal cord compression. Patients can be eligible if surgical resection has been performed\n* Patients with spine instability as judged by a Spinal Instability Neoplastic Score (SINS) of \\>12\n* Dominant brain metastasis requiring surgical decompression\n* Surgical resection of all metastases (i.e. no lesion available to be treated with SABR)\n* Complete response to systemic therapy, defined as the absence of visible disease on imaging\n* Pregnant or breast feeding","ALL","18 Years",{"count":20,"type":21},598,"ESTIMATED","INTERVENTIONAL",[24],"NA","Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques, while trying to avoid healthy tissues and organs. However, SABR treatment requires increased planning, treatment time, cost and potential for higher toxicity due to the higher dose. The purpose of this study is to compare single fraction (SF) SABR vs. multiple fraction (MF) SABR in regards to toxicities, progression-free survival, quality of life (QoL), and cost-effectiveness. In a subset of patients, we will also compare patient QoL, hospitalization rates, and cost-effectiveness between patients who complete QoL questionnaires, record symptoms and receive healthcare provider-guided intervention vs. patients who complete QoL questionnaires only.",[27,28,29,30],"Oligometastatic Disease","Oligoprogression","Toxicity Due to Radiotherapy","Quality of Life","RECRUITING","2026-06-23",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":35},"2025-04-16",{"date":39,"type":21},"2035-05-30",{"name":41,"class":42},"Robert Olson","OTHER",14,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100456454","phase-2-terps-trial-for-de-novo-oligometastic-prostate-cancer-100456454","NCT05223803","TERPS Trial for de Novo Oligometastic Prostate Cancer","Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial","Inclusion Criteria:\n\n1. Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are seen on imaging. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or PSMA PET-CT scan.\n\n   1. CT or MRI scan within 6 months of enrollment\n   2. Bone scan within 6 months of enrollment\n   3. Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months of enrollment (PET-CT scan is reasonable for study entry imaging as an alternative to CT\u002FMRI scan and bone scan)\n2. Histologic confirmation of malignancy (primary or metastatic tumor).\n3. Patient may have had prior systemic therapy and\u002For ADT associated with treatment within 9-months of enrollment.\n4. PSA \\> 0.5 but \\\u003C100.\n5. Patient must be ≥ 18 years of age.\n6. Patient must have a life expectancy ≥ 12 months.\n7. Patient must have an ECOG performance status ≤ 2.\n8. Patient must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n1. Castration-resistant prostate cancer (CRPC).\n2. Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy\n3. Spinal cord compression or impending spinal cord compression.\n4. Suspected pulmonary and\u002For liver metastases (greater \\>10 mm in largest axis).\n5. Patient receiving any other investigational agents.\n6. Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist .\n7. Unable to lie flat during or tolerate PET\u002FMRI, PET\u002FCT or SABR.\n8. No radiographical evidence of cranial metastasis.\n9. Refusal to sign informed consent.","MALE",{"count":53,"type":21},122,[55],"PHASE2","This research is being done to see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.",[58,27],"Prostate Cancer","2026-05-29",{"date":61,"type":35},"2026-06-03",{"date":63,"type":35},"2022-10-18",{"date":65,"type":21},"2029-07-31",{"name":67,"class":42},"University of Maryland, Baltimore",10,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100639502","phase-2-mri-guided-adaptive-radiotherapy-for-limited-peritoneal-metastases-maracas-trial-100639502","NCT07593261","MRI-Guided Adaptive Radiotherapy for Limited Peritoneal Metastases (MARACAS Trial).","MARACAS: A Phase II Trial of MRI-guided Adaptive Stereotactic RAdiotherapy in oligometastatiC Patients With Peritoneal Spread.","MARACAS","Inclusion Criteria:\n\n* Age ≥18 years\n* ECOG performance status 0-2\n* Life expectancy ≥6 months\n* Up to 5 MRI-visible peritoneal nodules\n* PCI ≤20\n* No prior radiotherapy in the same abdominal region within 6 months\n* Signed informed consent\n* History of prior CRS and\u002For HIPEC\n\nExclusion Criteria:\n\n* Diffuse peritoneal carcinomatosis\n* 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)\n* Significant comorbidities (such as: severe cardiac or coagulative disease, moderate or severe\n* restrictive\u002Fobsiructive lung deficit, severe cognitive impairment, moderate and severe renal and hepatic impairment.\n* Pregnancy or breastfeeding\n* MRI contraindications (e.g., pacemaker, severe claustrophobia)",{"count":78,"type":21},34,[55],"This prospective phase II study evaluates the efficacy and safety of MRI-guided stereotactic body radiotherapy (MRIgSBRT) in patients with oligometastatic peritoneal carcinomatosis from gastrointestinal or gynecological tumors. Eligible patients with up to 5 MRI-visible peritoneal lesions and PCI ≤20 will be treated with MRIgSBRT using a hybrid MRI-linear accelerator with online adaptive planning and real-time tumor tracking.\n\nThe primary endpoint is radiologic response rate according to RECIST 1.1 criteria. Secondary endpoints include overall survival, progression-free survival, local control, chemotherapy-free survival, and treatment-related toxicity. The study aims to assess MRIgSBRT as a safe and non-invasive treatment option for selected patients with limited peritoneal metastatic disease.",[82,27,83],"Peritoneal Carcinomatosis","Peritoneal Metastases",[85,86,87,88,89],"MRI-guided radiotherapy","Stereotactic body radiotherapy","Peritoneal carcinomatosis","Peritoneal metastases","Online adaptive radiotherapy","NOT_YET_RECRUITING","2026-05-12",{"date":93,"type":35},"2026-05-18",{"date":95,"type":21},"2026-07",{"date":97,"type":21},"2032-07",{"name":99,"class":42},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",1,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":100},"100544792","early-phase-1-real-time-atherosclerosis-activity-after-thoracic-radiotherapy-using-sodium-fluoride-positron-emission-tomography-100544792","NCT06373497","Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography","IT2023-08-ATKINS-ATHERO-RT: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography","Inclusion Criteria\n\n* Age ≥ 18 years.\n* Have clinical stage II-III or oligo-metastatic stage IV malignancy (any histology) planned to be treated with thoracic radiotherapy (≥30 Gy) where the heart is in the treatment field.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.\n* Planning to receive standard of care radiotherapy treatment.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n* Ability to read, write, and understand English\n\nExclusion Criteria\n\n* Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002Fm2 or serum creatinine ≥1.5 mg\u002FdL.\n* Patients with a known or previous allergy to iodinated contrast, gadolinium contrast, and\u002For 18F-NaF tracer.\n* Inability to receive PET tracer.\n* Inability to receive MRI, requiring sedation for MRI, or prohibitive implant and\u002For device, including ferromagnetic implants and ferromagnetic foreign bodies.\n* Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.\n* Subjects that are pregnant or breastfeeding.\n* Subjects unable to comply with visit instructions, including inability to lie still, hold breathe, or follow procedure instructions.\n* Allergy to animal dander or animal-instigated asthma.\n* Any other condition which, in the opinion of the investigator, may make the patient a poor candidate for participation in a clinical trial",{"count":68,"type":21},[110],"EARLY_PHASE1","The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to:\n\n1. To deploy first-in-kind application of fluorine 18-sodium fluoride (18F-NaF) PET (Positron Emission Tomography) \u002FMRI (Magnetic Resonance Imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure\n2. To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and\n3. To measure perturbations in the immune-modulatory and metabolic states following thoracic RT (Radiation Therapy) exposure in patients at high risk of cardiac dysfunction.\n\nEligible patients will be adults (≥18 years old) with Stage II-III or oligo-metastatic stage IV malignancy (any histology) at high risk for RT-associated cardiac toxicity (defined as receiving ≥30 Gy (Gray) RT where the heart is in the treatment field54). The study will enroll a total of 10 subjects, recruited from Cedars-Sinai Medical Center. The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points. Blood will be collected at baseline, end of RT, and 6-months post-RT.",[27],[114,115,116,117,118,119],"Thoracic Radiotherapy","PET Imaging","MRI Imaging","18 F-NaF","Clinical Stage II","Clinical Stage III","2026-05-01",{"date":122,"type":35},"2026-05-07",{"date":124,"type":35},"2025-06-19",{"date":126,"type":21},"2026-10",{"name":128,"class":42},"Katelyn Atkins",{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":137,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":43},"100529944","phase-2-niraparib-rechallenge-after-surgery-in-ovarian-cancer-patients-with-oligometastatic-progression-100529944","NCT06180356","Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression","Phase II Study to Assess the Efficacy of Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression (The ANALLISA Study)","ANALLISA","Inclusion Criteria:\n\n1. Written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female patients ≥ 18 years of age.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Patients must have a life expectancy ≥16 weeks.\n5. Histologically confirmed high grade serous or endometrioid OC who have an OMP during or after the first maintenance therapy with any PARPi.\n6. Oligometastatic progression defined as 1-5 lesions (according to European Society for Radiotherapy and Oncology \\[ESTRO\\] and American Society for Radiation Oncology \\[ASTRO\\] consensus).\n\n   Note: Metastatic lymph nodes located within the same anatomical lymph-node chain or station, as confirmed on surgical specimen, shall be counted collectively as one single metastatic lesion.\n7. Patients must have undergone secondary cytoreductive surgery with centrally confirmed no evidence of macroscopic residual tumor after surgery (complete resection).\n8. Patients with asymptomatic and treated brain metastases are allowed if:\n\n1\\. Neurosurgical resection ≥ 28 days prior to initiation of study treatment. 2. Not requiring radiotherapy. 3. Not receiving steroid therapy or anticonvulsant for at least 7 days before the first dose of study treatment.\n\n9\\. Documented breast cancer gene 1\u002F2 (BRCA1\u002F2) status and\u002For homologous recombination (HR) status.\n\nNote I: Patients with germline or somatic mutations in the BRCA1 or BRCA2 genes will be considered with the HR status known and classified as with homologous recombination deficiency (HRD).\n\nNote II: HR test must be performed before C1D1.\n\n10\\. Patients who have received prior PARPi monotherapy or PARPi together with bevacizumab as maintenance treatment.\n\n11\\. Patients should have had benefit of prior PARPi defined by treatment for ≥12 months from initiation of PARPi maintenance until the date of OMP or have experienced tumor progression after treatment completion. Tumor progression must have been confirmed by computed tomography (CT) and\u002For PET-CT scan.\n\n12\\. If prior treatment was niraparib, no significant toxicity that led to treatment discontinuation.\n\n13\\. Willingness to provide formalin fixed, paraffin embedded (FFPE) tumor tissue from primary, if available, and secondary surgeries and blood samples at the time of the inclusion, every 12 weeks, and at the end of treatment (EoT).\n\n14\\. Able to take oral medications. 15. Patients must start treatment 3 to 8 weeks from surgery, once recovered from surgery.\n\n16\\. Women of childbearing potential who engage in heterosexual intercourse must agree to use institution specified method(s) of contraception and must refrain from donating eggs in the time period specified in the study protocol. Women of childbearing potential must have a negative serum or a highly sensitive urine pregnancy test within 72 hours before study treatment initiation.\n\n17\\. Patient has adequate bone marrow, liver, and renal function:\n\n* Hematological: White blood cell (WBC) count \\> 3.0 x 109\u002FL, absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL, platelet count ≥ 100.0 x109\u002FL, and hemoglobin ≥ 9.0 g\u002FdL (≥ 5.6 mmol\u002FL).\n* Hepatic: total bilirubin ≤ institutional upper limit of normal (ULN) (except for Gilbert's syndrome); alkaline phosphatase (ALP) ≤ 2.5 times ULN; aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 times ULN. 11).\n* Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal.\n\n  18\\. Patients must be accessible for treatment follow-up.\n\nExclusion Criteria:\n\n1. Patients with symptomatic or systemic progressive disease not fulfilling OMP disease criteria.\n2. Patients with residual disease after secondary cytoreductive surgery.\n3. Patients with persistent toxicities (\\> Common Terminology Criteria for Adverse Events (CTCAE) grade 2) caused by previous cancer therapy.\n4. Patients unable to swallow oral medication or with any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of niraparib, or put the study outcomes at undue risk.\n5. Patients with clinically significant cardiovascular disease such as uncontrolled hypertension, uncontrolled or symptomatic arrythmias, congestive heart failure (CHF), or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification.\n6. Patients treated with previous PARPi therapy who have any known, persistent (\\>4 weeks), ≥Grade 3 anemia, neutrophil count decrease or platelet count decrease.\n7. Patients with known history of human immunodeficiency virus (HIV), or active hepatitis C Virus (HCV), or active hepatitis B Virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.\n8. Patients with known hypersensitivity or allergy to prior niraparib treatment or any of the excipients of the product.\n9. Patients who have received a transfusion of platelets or red blood cells, colony-stimulating factors or have any other laboratory abnormality within 2 weeks prior niraparib treatment that might confound or interfere with the study result.\n10. Participation in another clinical trial, interventional or observational, until the Study's safety visit.\n\n    Note: participation in retrospective studies or data analysis is allowed.\n11. Patients who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study treatment.\n12. Patients with myelodysplastic syndrome (MSD)\u002FAcute myeloid leukemia (AML), with history of MSD\u002FAML or with features suggestive of MDS\u002FAML.\n13. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n14. Other malignancy unless curatively treated with no evidence of disease ≥ 5 years prior to study enrollment. Note: Patients with adequately non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) and stage 1 low grade endometrial carcinoma are not excluded.\n15. Vaccination with any live virus vaccine within 28 days prior study treatment initiation.","FEMALE",{"count":139,"type":21},30,[55],"The ANALLISA study is a fast, proof-of-concept, phase II clinical trial which aims to assess the efficacy of niraparib rechallenge treatment after secondary cytoreductive surgery in ovarian cancer (OC) patients with oligometastatic progression (OMP) after first maintenance therapy with any PARP inhibitor. A total of 30 patients with OC and OMP will be enrolled and will receive treatment with niraparib 300 or 200 mg, according to body weight or platelet count. Patients will start treatment within 8 weeks after surgery and will receive it until progressive disease or treatment discontinuation. The main purpose of the study is to evaluate progression-free survival (PFS) of niraparib rechallenge in OC patients with OMP and no residual disease after secondary cytoreductive surgery.",[143,27,144],"Ovarian Cancer","Serous Ovarian Tumor","2026-04-17",{"date":147,"type":35},"2026-04-22",{"date":149,"type":35},"2024-12-03",{"date":151,"type":21},"2028-01",{"name":153,"class":42},"MedSIR",{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":100},"100599023","phase-1-trial-of-oligometastasis-sbrt-with-immediate-simulation-free-treatment-delivery-oligo-swift-100599023","NCT07079098","Trial of Oligometastasis SBRT With Immediate, Simulation-Free Treatment Delivery (OLIGO-SWIFT)","Pilot\u002FPhase I Trial of Oligometastasis SBRT With Immediate, Simulation-Free Treatment Delivery (OLIGO-SWIFT)","Inclusion Criteria:\n\n* Participants must have histologically, cytologically, or radiographically or confirmed cancer that is oligometastastatic (defined in this protocol as up to 5 active sites of disease at time of trial enrollment). Note that previous ablative therapy to the treatment site (excluding prior external beam radiation) is permitted, such as previous microwave ablation or radiofrequency ablation.\n* Age ≥18 years.\n* Performance status: Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2\n* Estimated life expectancy of at least 3 months\n* Participants must be considered a candidate for SBRT by the treating physician\n* Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 1 week prior to radiation therapy and renewed no sooner than 1 week following radiation therapy, with the exception of endocrine therapies, which can continue through radiation treatment.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Participants must have a diagnostic CT, MRI, or PET\u002FCT of the site(s) intended for treatment, with or without contrast, acquired no more than 30 days prior to study consent.\n\nExclusion Criteria:\n\n* Prior radiotherapy to any site overlapping with the projected site for protocol treatment.\n* Participants with isolated vertebral metastases except for sacral spine; participants with osseous spine disease can be treated upon this protocol, but those sites (cervical, thoracic, lumbar spine) are not permitted for treatment upon this study. Such participants could be enrolled for treatment to other, concurrent (e.g., visceral, or non-spine bone) disease on this study.\n* Pregnant or breastfeeding women are excluded from this study.\n* Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by the treating physician or protocol principal investigator (PI), documentation of this exception is sufficient in lieu of a pregnancy test.",{"count":162,"type":21},15,[164],"PHASE1","This study is for participants whose cancer is oligometastatic, meaning it has spread to up to five spots in their body and their doctor recommends that they have stereotactic body radiation therapy (SBRT) to treat these cancer sites. SBRT is a type of radiation therapy that may help people with oligometastatic disease live longer without cancer progression. SBRT is usually given in addition to other cancer treatments, like chemotherapy, immunotherapy, or hormone therapy.\n\nPreparing for SBRT can take up to a week or longer. This can make it harder for participants to receive SBRT and coordinate care. This can also mean a longer time until symptoms from cancer sites improve. Doctors would like to treat oligometastatic cancers more quickly by reducing the time it takes to plan for the SBRT.\n\nThe typical workflow for SBRT includes doctors doing a simulation which requires a CT (Computerized Tomography) scan. The CT scan is used to create a treatment plan. It can take time to schedule this CT scan and then it normally takes another 5-10 days to create a treatment plan.\n\nA way to reduce the planning time for SBRT is to use the CT scan (or other radiology scan types, like magnetic resonance imaging \\[MRI\\] or positron emission tomography \\[PET\\]) that participants had when their cancer was diagnosed to plan their SBRT. This eliminates the scheduling of an additional CT scan and the 5-10 day planning time. This is called CTsim-free (CT simulation-free) treatment planning.\n\nCT-sim-free radiation therapy planning has been shown to be effective in treating cancers that are causing pain in people with more advanced or widespread cancers. This study is being done to find out if it is safe and effective to use CTsim-free planning for SBRT to treat oligometastases.",[167,27],"Oligometastasis",[169,170],"Stereotactic Body Radiation Therapy","SBRT","2026-03-02",{"date":173,"type":35},"2026-03-03",{"date":175,"type":35},"2026-02-27",{"date":177,"type":21},"2027-02",{"name":179,"class":42},"Case Comprehensive Cancer Center",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":100},"100618594","phase-2-125i-seed-implantation-plus-systemic-therapy-for-oligoprogressive-nsclc-or-colorectal-cancer-100618594","NCT07333651","125I Seed Implantation Plus Systemic Therapy for Oligoprogressive NSCLC or Colorectal Cancer","Standard-of-Care Systemic Therapy With or Without Image-Guided 125I Seed Implantation in Patients With Oligoprogressive Metastatic Non-Small Cell Lung Cancer or Colorectal Cancer: An Open-Label, Randomized, Controlled Phase 2 Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed metastatic non-small cell lung cancer (NSCLC) or colorectal cancer (CRC).\n* Presence of metastatic disease with extracranial oligoprogression, defined as progression in up to five (≤5) individual lesions on CT or PET\u002FCT imaging, while other known disease sites remain stable or controlled.\n* Received at least one prior line of standard systemic anticancer therapy, including maintenance therapy, for metastatic disease.\n* All oligoprogressive lesions are technically feasible and considered safe for image-guided 125I seed implantation, as determined by the treating interventional team.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Adequate organ function to undergo interventional procedures and systemic therapy, per institutional standards.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Leptomeningeal disease or diffuse central nervous system involvement. Uncontrolled infection or serious medical comorbidities that, in the investigator's judgment, would preclude safe participation or interventional procedures.\n* Prior radiotherapy or brachytherapy requiring re-irradiation to the same tumor location planned for 125I seed implantation.\n* Known bleeding diathesis or uncorrectable coagulation disorders contraindicating interventional procedures.\n* Any other condition that, in the investigator's judgment, would make the patient unsuitable for the study.",{"count":188,"type":21},90,[55],"Most patients with metastatic cancer eventually develop resistance to systemic therapy. A subset of patients experience oligoprogression, characterized by progression at a limited number of lesions while other disease sites remain controlled by ongoing systemic therapy. This randomized phase 2 trial evaluates whether image-guided 125I seed implantation targeting all oligoprogressive extracranial lesions, combined with standard-of-care systemic therapy, improves progression-free survival compared with standard-of-care systemic therapy alone in patients with metastatic NSCLC or CRC.",[27],[193,28,194,195],"lodine-125 Seed Brachytherapy","Non-Small Cell Lung Cancer","Colorectal Cancer","2026-01-02",{"date":198,"type":35},"2026-01-12",{"date":200,"type":21},"2026-01",{"date":202,"type":21},"2028-01-01",{"name":204,"class":42},"Li Min",{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":212,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":100},"100586713","stereotactic-radiotherapy-versus-palliative-conventional-radiotherapy-for-oligoprogressive-metastatic-cancers-100586713","NCT06918951","Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers","Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers: A Double-Blind Randomized Phase III Trial","Inclusion Criteria:\n\n1. Age 19 or older\n2. Able to provide informed consent\n3. Histologically confirmed solid malignancy (excluding lymphoma or myeloma) with metastatic disease detected on imaging\n4. Biopsy of metastasis at some time prior to enrollment is preferred, but not required\n5. ECOG performance status 0-2\n6. Life expectancy ≥ 6 months\n7. Progression meeting RECIST criteria in up to 5 individual lesions. Progression may be defined as:\n\n   1. Progression of an individual metastasis according to RECIST 1.1 criteria (≥ 20% enlargement of the tumour vs. baseline or nadir, taking as reference the smallest diameter seen prior to starting or during systemic therapy, and associated with a 5 mm minimum increase in size) OR\n   2. Unambiguous development of a new metastatic lesion at least 5 mm in size OR\n   3. Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2-3 months apart with a minimum 5 mm increase in size from baseline.\n   4. A progressing primary tumor is eligible as per the criteria above\n8. If the participant is on systemic therapy at the time of oligoprogression:\n\n   The most recent systemic therapy agent must have been delivered for a total of at least 3 months, with an initial partial response (PR), complete response (CR) or stable disease (SD) prior to the development of oligoprogressive lesions\n9. If the participant is not on systemic therapy at the time of oligoprogression:\n\n   (i.e., \"oligorecurrence\"(1), however, included as \"oligoprogression\" for the purpose of this study protocol):\n10. There must be PR, CR or SD persisting for at least 3 months prior to the development of oligoprogressive lesions\n11. Participants who are not on systemic therapy at the time of oligoprogression must have other site(s) of disease (metastases or primary tumor) that are stable or resolved and have not received definitive treatment (inclusive of surgery, radical doses of radiotherapy including SABR, or ablation) and are not going to receive SABR.\n12. All sites of oligoprogression can be safely treated\n13. Restaging completed within 12 weeks prior to randomization (see section 5.1)\n14. Negative urine pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of radiotherapy start date.\n\nExclusion Criteria:\n\n1. Serious medical comorbidities precluding radiotherapy. These include ataxia-telangiectasia or scleroderma, Crohn's disease in participants where the gastrointestinal (GI) tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy.\n\n   a. For participants with oligoprogressive lesions in the lung or thorax, this includes interstitial lung disease.\n2. Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, provided that the composite plan meets dose constraints herein. For participants treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. A tissue recovery factor may be used in these calculations and if so, must be clearly documented, along with elapsed time from previous radiotherapy, and approved by the local principal investigator.\n3. Current malignant pleural effusion, malignant ascites, or leptomeningeal disease\n4. Inability to treat all sites of oligoprogressive disease\n5. Liver metastases requiring placement of fiducial markers for SABR, as this would compromise successful blinding. Liver metastases are eligible if: 1) they are treated at an institution that offers liver SABR without fiducial markers or 2) pre-existing markers such as surgical clips or calcifications would serve as fiducial markers\n6. Brain metastasis \\> 3.5 cm in size or a total volume of brain metastases greater than 30 cc.\n7. Clinical or radiologic evidence of spinal cord compression. Participants can be eligible if surgical resection has been performed.\n8. Participants with spine instability as judged by a Spinal Instability Neoplastic Score (SINS) of \\>12.\n9. Dominant brain metastasis requiring surgical decompression\n10. For participants with liver metastases; moderate\u002Fsevere liver dysfunction (Child Pugh B or C)\n11. Liver metastases located in the \"Biliary no fly zone\" defined for this trial as common biliary track, cystic duct and distal branches (1 cm) + 5 mm\n12. Surgical resection of all oligoprogression metastases (i.e. no lesion available to be treated with SABR)\n13. Pregnant or lactating individuals","19 Years",{"count":214,"type":21},194,[24],"STOP-2 is a phase III multi-institutional double-blind randomized trial. 194 participants will be enrolled in this trial. Participants will be randomized in a 1:1 ratio between the Control Arm vs. the Experimental Arm.\n\nParticipants, enrolling oncologists, and the statistician will be blinded to trial arm assignment.\n\nIn the control arm, radiotherapy will consist of 8 Gy in 1 fraction to all sites of oligoprogression, and the experimental arm will consist of SABR treatment to all sites of oligoprogression.\n\nPrimary Objectives\n\n* To assess the impact of SABR, compared to palliative conventional radiotherapy, on Progression-free survival on next line systemic therapy (PFS-NEST), oncologic outcomes, and Quality of Life (QOL) in participants with 1-5 oligoprogressing lesions.\n* To assess the feasibility of the clinical trial in terms of accrual and success of double-blinding.\n\nSecondary Objectives\n\n* To evaluate and compare the impact of SABR and palliative radiation therapy on the overall survival (OS), progression free survival (PFS), polymetastatic progression-free survival (PPFS);\n* To assess and compare the proportion of participants receiving additional radiation therapy and other metastasis-directed interventions during follow-up between both arms;\n* To compare the impact of SABR and palliative radiation therapy on the time to initiation of the next line of systemic therapy;\n* To identify and compare the anatomic sites of disease progression between the experimental (SABR) and control (palliative radiation) arms;\n* To compare the treatment related toxicity among participants in each arm;\n* To evaluate and compare the quality of life among participants in each arm;\n* To assess the cost-effectiveness of the experimental arm compared to the control arm.",[28,27,218],"OligoProgressive Metastatic Disease",[220,221,222,223],"SABR","Radiotherapy","Quality of life","Metastatic Cancer","2025-12-08",{"date":226,"type":35},"2025-12-15",{"date":228,"type":35},"2025-12-04",{"date":230,"type":21},"2033-06-01",{"name":232,"class":42},"British Columbia Cancer Agency",{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":100},"100453325","mr-linac-guided-ultra-hypofractionated-rt-for-prostate-cancer-smart-p01-and-smart-p02-100453325","NCT05183074","MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02)","Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized (SAMRT-P01) and Oligo-metastatic (SMART-P02) Prostate Cancer","SMART-P01\u002F02","Inclusion Criteria:\n\n* Age≥18 years。\n* Histology confirmed prostate cancer.\n* Risk stratification, localised disease including patients with low-risk(cT1-T2a，PSA \\\u003C10ng\u002FmL，Gleason score≤6) who refuse active surveillance, favorable or unfavorable intermediate-risk and selected high-risk(cT2b-T3a or minimally T3b，PSA 10-40ng\u002FmL，Gleason score 7-8) disease.\n* Oligo-metastatic disease including patients with prostate in-situ and oligometastatic disease (no limit to mets number and organs, with all metastatic foci can be safely treated by radical SBRT dose)\n* ECOG 0-2\n* Postate gland volume ≤100cc\n* IPSS score of \\\u003C18\n* Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed\n\nExclusion Criteria:\n\n* Contraindications to MRI.\n* TURP within the past 6 months\n* Ulcerative colitis, Crohn's Disease, ataxia telangiectasia, or systemic lupus erythematosus\n* Previous pelvic irradiation\n* Refuse contraception",{"count":242,"type":21},50,[24],"1. To investigate the tolerability of MR-linac based stereotactic ablative radiotherapy (MRL-SBRT)for patients with localized prostate cancer\n2. To assess the acute and late toxicities, efficacy and quality of life for patients treated by MRL-SBRT\n3. To simulate the dose planning and assess the feasibility of simultaneous-boost for MR-prominent foci\n4. To investigate the relationship between the changes of blood and tissue biomarkers and manifestations on mp-MRI pre-\u002Fpost-MRL-SBRT, to further ascertain the predictive factors of local persisting and\u002For relapse disease",[58,246,247,248,249,250,27],"Radiotherapy Side Effect","Magnetic Resonance-linac","Stereotactic Ablative RT","Adaptive Radiotherapy","Localised Disease",{"date":252,"type":35},"2025-12-11",{"date":254,"type":35},"2021-02-01",{"date":256,"type":21},"2027-12-31",{"name":258,"class":42},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100549886","phase-1-lymphocyte-support-to-sbrt-in-patients-with-oligo-metastatic-solid-cancer-100549886","NCT06439888","Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer","Pan-lesions SBRT Combined With Lymphocyte Support Through ATRA-driven Blockade of MDSC in Patients With Oligo-metastatic Solid Cancer","LySATRA","Inclusion Criteria:\n\nParticipants are eligible for enrolment in the study only if ALL of the following criteria apply:\n\nI1. Adult male or female patients (≥ 18 years of age at inclusion);\n\nI2. Histologically or cytologically proven solid cancer at the oligometastatic stage and\u002For oligoprogressive amenable to pan-lesion SBRT, as defined by:\n\n1. \\[1-5\\] active tumor lesions with a largest diameter comprised between \\[1-5\\] cm,\n2. The disease can be either genuinely oligometastatic, oligoprogressive, or an induced oligometastatic disease\n3. All active tumor lesions (progressive and\u002For hypermetabolic) that match criterion I2a must be eligible to SBRT in terms of location and radiotherapy constraints. 'Active lesion' is defined as either: hypermetabolic on PET-scan, recent increase of \\>20% of its largest diameter on CT-scan, and\u002For any new lesion of ≥ 1cm on the most recent CT-scan\n4. SBRT to all active lesions must be feasible over a two-week period,\n5. Whatever the primary tumor type I3. Patients must agree to comply with biopsy and blood sampling for research purpose;\n\nI4. Minimal wash-out periods from last administration of treatments to the first day of SBRT must be:\n\n1. Systemic chemotherapy including cytotoxic, immunotherapy, targeted therapy, hormone therapy, any investigational agent \\> 4 weeks,\n2. Immunosuppressive medication \\> 4 weeks, with the exceptions of intranasal, topical, and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceeding 10 mg\u002Fday of prednisone, or an equivalent corticosteroid,\n3. Live attenuated vaccination \\> 4 weeks,\n4. Major surgery \\> 4 weeks; I5. WHO 0-1 and ECOG Performance Status 0-1;\n\nI6. Patients must have adequate organ function defined as follows:\n\n1. White blood cell count of ≥ 1,500\u002Fmm3,\n2. Lymphocyte count of ≥ 800\u002Fmm3,\n3. Platelet count of ≥ 100,000\u002Fmm3,\n4. Hemoglobin \\> 9 g\u002FdL, Serum ALT and AST ≤2.5 ULN (or if liver metastases are present must be ≤ 5x ULN)\n\nf. Serum creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance; I7. Female patients must either be of non-reproductive potential or must have a negative serum pregnancy test within 3 days prior to the initiation of the study drug and\u002For perform a urine test in addition to the serum test before the first dose of ATRA, if the result of the serum test cannot be obtained within 3 days. Fertile men with a female partner of childbearing potential must agree to use male condom plus spermicide and childbearing potential women must have agreed to use at least one highly effective contraceptive method during treatment on this trial and for up to 1 month after the last dose of ATRA; Pregnancy testing and contraception counseling should be repeated monthly throughout the period of ATRA treatment.\n\nI8. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol; I9. Patients must be affiliated to a social security system or beneficiary of the same 4.2. Non-inclusion criteria\n\nParticipants are not eligible for enrolment in the study if ANY of the following criteria applies:\n\nE1. Evidence of disease rapidly progressing at the time of screening according to the two last best-fitted imaging modalities (CT-scans, MRI, PET-scan), at the discretion of the investigator and the multidisciplinary board (RCP); E2. Any evidence of brain metastasis; E3. Any situation where irradiation of the target site(s) would imply re-irradiation of a formerly irradiated tumor site; E4. Bone metastasis located in a femoral bone if risk of pending fracture is high; E5. Liver metastasis adjacent to the stomach or small bowel and liver metastasis that leads to a volume of uninvolved liver \\\u003C 700 cc; E6. Patients with any concurrent severe condition (grade 3 or beyond according to CTCAE V5.0) and\u002For uncontrolled medical condition that could compromise participation in the study; E7. Any psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent; E8. Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Sponsor. Examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen. Patients with a completely treated prior malignancy who are no longer treated (including maintenance therapy) and no evidence of disease for ≥ 2 years are eligible; E9. Chronic treatment with systemic corticosteroids or another immunosuppressant including, but not limited to systemic corticosteroids at doses exceeding 10 mg\u002Fday of prednisone or equivalent, methotrexate, azathioprine, and TNF-α blockers. Use of immunosuppressive medications for the management of investigational product-related AEs or in subjects with contrast allergies is acceptable. The use of topical, inhaled and intranasal corticosteroids is permitted; E10. Patients with tumor(s) that invade major vessels, as shown unequivocally by imaging studies; E11. Patients with central lung metastasis (i.e within 2 cm from hilum) that are cavitary as shown unequivocally by imaging studies; E12. Persisting significant toxicities related to prior treatments i.e. ≥ Grade 2 adverse event according to CTCAE V5.0 criteria, except for alopecia and biological values defined in inclusion criteria I6; E13. Known allergy or hypersensitivity to the study drug. The study drug is contraindicated in patients with soy or peanut allergy; E14. Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); E15. Patients at risk of QT prolongation (including patients with hypokaliemia, baseline QT\u002FQTc interval \\> 470 ms (for women) and \\> 450 ms (for men)); E16. Pregnant or breastfeeding women; E17. Persons deprived of their freedom or under guardianship, or for whom it would be impossible to undergo the medical follow-up required by the trial, for geographic, social or psychological reasons.\n\nWomen of childbearing potential must have a negative serum β-HCG pregnancy test within 3 days prior to the administration of the first study treatment (and\u002For a urine test).\n\nSexually active women of childbearing potential must agree to use a highly effective method of contraception, or to abstain from sexual activity during the study and for at least 1 months after the last study treatment administration.\n\nSexually active male patients must agree to use condom during the study and for at least 1 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.\n\nOf note:\n\nA woman is considered of childbearing potential following menarche and until becoming post-menopausal (≥ 12 months of non-therapy-induced amenorrhea) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral oophorectomy and bilateral salpingectomy.\n\nA highly effective birth control method is a one which can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include: combined (estrogen and progestogen containing) hormonal contraception; progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence during the entire period of risk associated with study treatment. To prevent the risk of interaction between the study drug and hormonal contraceptives, hormonal contraceptives should be supplemented with a barrier method (preferably male condom). Following methods are considered as unacceptable methods (non-exhaustive list): periodic abstinence (calendar, symptothermal, post-ovulation methods) and withdrawal (coitus interruptus).",{"count":268,"type":21},58,[164,55],"The goal of this clinical trial is to assess safety of pan-metastases directed SBRT combined with ATRA and the lympho-protective efficacy of ATRA upon radiation-induced lymphopenia.\n\nThis is a French bicentric, open label, phase I\u002FII clinical study that will comprise two parts. Part I will evaluate the safety of the combination based on a single-arm safety run design, while Part II will be randomized (ratio 1:1) and will study SBRT with or without ATRA.\n\nPatients enrolled will be treated with:\n\n* SBRT to all lesions more than 1cm, on week days (from Monday to Friday), over a maximum of 2 weeks,\n* With or without (for part II patients randomized in the control arm) ATRA therapy: ATRA 150 mg\u002Fm\\^2\u002Fday for 3 days every 3 weeks for a maximum of 4 cycles (about 3 months), starting on the first day of radiation therapy.\n\nThe expected rate of patients who will have lymphopenia of grade 2 or higher in the control arm at 6 weeks post-radiotherapy is 50%.\n\nAt a one-sided level of statistical significance of 0.07, the randomization of 52 patients (26 patients in each arm) will provide 85% power to detect a decrease in this rate to 15% in the SBRT+ATRA arm, using Fisher's exact test.",[27,272],"Solid Tumor, Adult","2025-11-24",{"date":275,"type":35},"2025-12-01",{"date":277,"type":35},"2024-07-11",{"date":279,"type":21},"2027-01",{"name":281,"class":42},"Gustave Roussy, Cancer Campus, Grand Paris",2,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":291,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":295,"conditions":296,"keywords":299,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":100},"100460608","phase-2-local-consolidative-radiation-therapy-plus-tki-versus-tki-alone-in-driver-mutated-om-nsclc-100460608","NCT05277844","Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC","A Phase II Randomized Controlled Trial of TKI Alone Versus TKI and Local Consolidative Radiation Therapy in Oncogene Driver Mutated Oligo Metastatic Non Small Cell Lung Cancer Patients","TARGET-01","Inclusion Criteria:\n\n1. Patients with pathologically proven diagnosis of NSCLC\n2. Patients with positive oncogene driver mutation (EGFR or ALK\u002FROS)\n3. Patients who have received at least 2-4 months of TKI therapy without progression\n4. Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)\n5. Patients suitable for local consolidative therapy\n6. Adequate end-organ function CBC\u002Fdifferential obtained within 15 days prior to registration on study, with adequate bone marrow function defined as follows:\n\n   * Absolute neutrophil count (ANC) ≥ 500 cells\u002Fmm3;\n   * Platelets ≥ 50,000 cells\u002Fmm3;\n   * Hemoglobin ≥ 8.0 g\u002Fdl (Use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable);\n7. Patients with ECOG performance status of 0-2\n8. Age \\> 18 years\n9. For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration\n\nExclusion Criteria:\n\n1. Patients with progressive disease after 2-3 months of initial TKI therapy\n2. Patients with negative oncogene driver mutations (EGFR\u002FALK\u002FROS)\n3. Patients not suitable for local consolidative radiation therapy\n4. Patients who are not suitable for further continuation of TKI therapy due to toxicity\n5. Severe, active co-morbidity defined as follows:\n\n   * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months;\n   * Transmural myocardial infarction within the last 6 months;\n   * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;\n6. Patients with prior history of radiation therapy to thorax\n7. Patients with second malignancy (Synchronous or Metachronous)\n8. Pregnancy","99 Years",{"count":293,"type":21},106,[55],"A Phase II randomized controlled trial of TKI Alone versus TKI and Local Consolidative Radiation Therapy in oncogene driver mutated oligo metastatic Non-small cell lung cancer patients.",[27,297,298],"Non-small Cell Lung Cancer","Driver Mutation",[300,301,302,303,220,304],"Oligometastatic NSCLC","Driver mutation","TKI","Local consolidative therapy","Oligometastases","2025-09-03",{"date":307,"type":35},"2025-09-10",{"date":309,"type":35},"2019-11-11",{"date":311,"type":21},"2027-11-11",{"name":313,"class":314},"Tata Memorial Hospital","OTHER_GOV",{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":291,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":327,"conditions":328,"keywords":330,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":100},"100460624","phase-3-standard-maintenance-therapy-smt-vs-local-consolidative-radiation-therapy-and-smt-in-om-nsclc-100460624","NCT05278052","Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC","Standard Maintenance Therapy Versus Local Consolidative Radiation Therapy and Standard Maintenance Therapy in 1-5 Sites of Oligometastatic Non-small Cell Lung Cancer (NSCLC): A Phase III Randomized Controlled Trial","TARGET-02","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Patients with ECOG performance status of 0-2\n3. Patients with pathologically proven diagnosis of NSCLC\n4. Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than or equal to 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)\n5. Patients who have received standard duration of systemic therapy (4 - 6 cycles) without progression of the disease\n6. Patients suitable for definitive therapy to the primary disease\n7. All the Oligometastases lesions should be radiologically visible and suitable for ablative doses of radiation in accordance with the dose fractionation regimens specified in the protocol.\n8. Patients who have received ablative radiation therapy or surgery or RFA for metastatic sites at presentation or during systemic therapy will be eligible provided the total number of oligometastatic sites at the time of study entry (treated site included) is less than or equal to five.\n9. Patients who have received palliative RT for symptomatic bony metastases or RFA will also be eligible provided the treated site is under control on imaging. If not controlled, could be eligible for study if further ablative doses of radiation can be delivered according to the treating physician.\n10. Patients who underwent surgical decompression, or stabilization followed by palliative radiation therapy for bony metastases will be eligible in the study provided the treated site is under control on imaging and patient has less than 5 sites of metastases at the time of study entry.\n11. Adequate end organ function CBC\u002Fdifferential obtained within 15 days prior to registration on study, with adequate bone marrow function defined as follows:\n\n    * Absolute neutrophil count (ANC) ≥ 500 cells\u002Fmm3;\n    * Platelets ≥ 50,000 cells\u002Fmm3;\n    * Hemoglobin ≥ 8.0 g\u002Fdl (Use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable);\n12. For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration;\n13. Patients willing for written informed consent and must be willing to comply with the specified follow up schedule\n\nExclusion Criteria:\n\n1. Patients with progressive disease after initial standard systemic therapy\n2. Patients with oncogene driver mutations\n3. Patients with more than 5 sites of oligo metastases\n4. Patients with metastatic lesion size of more than 5 cm\n5. Patients with more than three metastatic lesion in one organ\n6. Patients not suitable for definitive radiation therapy to primary disease\n7. Patients not suitable for ablative radiation therapy to metastatic sites\n8. Patients with malignant peritoneal disease\n9. Patients with malignant pleural effusion\n10. Leptomeningeal disease\n11. Brain metastases in the brain stem\n12. Clinical or radiological evidence of spinal cord compression or metastases within 2 mm of spinal cord on MRI\n13. Severe, active co-morbidity defined as follows:\n\n    * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months;\n    * Transmural myocardial infarction within the last 6 months;\n    * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;\n14. Patients with prior history of radiation therapy to thorax\n15. Patients with previous history of malignancy within last 3 years from the date of diagnosis\n16. Pregnancy",{"count":324,"type":21},190,[326],"PHASE3","Standard Maintenance Therapy versus Local Consolidative Radiation Therapy and standard maintenance therapy in 1-5 sites of OligoMetastatic Non-small cell lung cancer (NSCLC): A Phase III Randomized Controlled Trial",[27,329],"Metastatic Non Small Cell Lung Cancer",[331,332,333,334,220],"Local Consolidative Radiation Therapy","Oligometastatic disease","NSCLC","Maintenance therapy",{"date":307,"type":35},{"date":337,"type":35},"2020-04-20",{"date":339,"type":21},"2028-04-20",{"name":313,"class":314},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":162},"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":349,"type":21},302,[24],"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.",[353,58,333,195,27],"Breast Cancer",[355,170,356],"radiotherapy","TwiCs","2025-07-30",{"date":359,"type":35},"2025-08-01",{"date":361,"type":35},"2025-04-15",{"date":363,"type":21},"2029-02-15",{"name":365,"class":366},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":379,"conditions":380,"keywords":381,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":100},"100491461","ablative-radiosurgery-vs-stereotactic-rt-in-5-fractions-with-sib-for-oligometastatic-bone-lesions-100491461","NCT05679427","Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions","A Randomised, Prospective, Monoinstitutional Study of Ablative Radiosurgery vs Stereotactic Radiotherapy in 5 Fractions, With Simultaneous Integrated Boost, for the Treatment of Bone Lesions in Oligometastatic Disease","ONES","Inclusion Criteria:\n\n* Performance status ECOG ≤2\n* Life expectancy \\> 6 months according to Mizumoto criteria\\*\n* Oligometastatic disease (Total number of metastases from 1 to 5: both synchronous and metachronous with maximum involvement of three organs in total - lymph nodes, bones, lungs, liver, adrenal gland, brain- with known histology\n* At least one bone metastasis treatable with SABR or SRS\n* Each secondary localization (synchronous, metachronous or oligoprogressive) must be treated with radical intent.\n* Patients may have received other anticancer treatments (surgery for initial site of disease or other metastases, chemotherapy, radiotherapy for other metastatic sites)\n\nExclusion Criteria:\n\n* Sites of disease not eligible for stereotactic radiotherapy\n* Serious medical comorbidities that preclude RT\n* Overlap with a previously treated volume of radiotherapy\n* Dimension greater than 5 cm for extra-cranial lesions.\n* Size greater than 3 cm for brain lesions\n* More than 1 brain metastases\n* Clinical or radiological evidence of spinal cord compression or epidural tumor within 2mm of the spinal cord\n* Radiological evidence of vertebral body fracture or involvement of more than 40% of the vertebral body\n* Radiological evidence of cortical involvement in long bones\n* Pregnant or breastfeeding women","85 Years",{"count":377,"type":21},307,[24],"This is a randomised prospective monoinstitutional study comparing radiosurgery at a total dose up to 24 Gy to five fraction stereotactic radiotherapy with simultaneous integrated boost (SIB) up to 50 Gy for the treatment of bone metastases in oligometastatic cancer treated with radical intent. At the end of the first 12 months from the start of the study an interim analysis will be performed taking into account all major endpoints for an initial evaluation of the study , with only an observational purpose, without subsequent protocol changes.",[27],[170,382,27,383],"Simultaneous Integrated Boost","Bone Metastases","2025-06-06",{"date":386,"type":35},"2025-06-11",{"date":388,"type":35},"2022-11-07",{"date":390,"type":21},"2027-12-07",{"name":392,"class":42},"IRCCS San Raffaele",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":100},"100567458","chemoimmunotherapy-followed-by-surgery-for-oligometastatic-esophagogastric-cancer-toro-protocol-100567458","NCT06668454","Chemoimmunotherapy Followed by Surgery for Oligometastatic Esophagogastric Cancer: (TORO Protocol)","Chemoimmunotherapy Followed by Surgery for Oligometastatic Esophageal and Gastric Cancer: A Phase II Clinical Trial (TORO Protocol)","TORO","Inclusion Criteria:\n\n* Histologically-proven cT1-4aN0-3M1 adenocarcinoma or squamous cell carcinoma of the esophagus, or EGJ according to the 8th edition of the Union for International Cancer Control (UICC) TNM classification for Esophageal Cancer;\n* Oligometastatic disease, which is defined as a maximum of five metastatic lesions, that is treatable by surgical resection or radiation. These five lesions can be present in a maximum of two organs (eg, liver, lung or adrenal gland). Lymph nodes are not counted as an organ. If metastatic retroperitoneal or supraclavicular lymph nodes are present, this lymph node site counts as one metastatic lesion, and together with the possible metastases in organs cannot exceed the number of five lesions.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;\n* Adequate cardiac and respiratory function by standard electrocardiogram and additional diagnostics in case of cardiopulmonary complaints or comorbidity (i.e. lung function test, or echocardiography)\n* Adequate blood work parameters for systemic therapy as per treating medical oncologist in terms of ANC, platelet count and hemoglobin.\n* Adequate renal function (glomerular filtration rate \\>50 mL\u002Fmin or serum creatinine ≤1.5x upper level of normal (ULN)) and adequate liver function (total bilirubin \\\u003C 2.5x ULN and alanine transaminase (ALT) \\\u003C 3x ULN);\n* A negative serum pregnancy test in women of child-bearing potential during screening period.\n* Age \\>18 and \\\u003C80 years old\n\nExclusion Criteria:\n\n* Patients with overt peritoneal or pleural dissemination, as detected on PET-CT or regular CT-scan. In patients in whom a diagnostic laparoscopy is indicated (to assess gastric involvement and the possibility to perform gastric tube reconstruction or to exclude peritoneal disease), tumor-positive cytology peritoneal fluid is also an exclusion criteria. Of note, positive microscopic peritoneal cytology which converts to negative after treatment is not an exclusion criteria (i.e. peritoneal or pleural fluid cytology must be negative at the time of enrollment, with no gross disease identified initially).\n* Multiple bone or brain metastases - up to one solitary bone met and\u002Fone solitary brain met is allowable as a metastatic site, if curative ablative radiotherapy can be given at the discretion of the treating physicians. Patients with multiple brain metastases or multiple bone metastases will be excluded.\n* Any other condition that, in the opinion of the investigator, would make the patient unsuitable for the study; particularly any condition that would make the patient unfit for surgery, radiation, chemotherapy or a combination thereof.\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma\u002Fatopy. Replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered a form of systemic treatment and is allowed. Use of non-systemic steroids is permitted.\n* Patients with active pregnancy, or lactation.","80 Years",{"count":403,"type":21},72,[24],"Esophageal cancer and cancers of the gastroesophageal junction (GEJ) are among the most common malignancies worldwide. The outcome for these patients remains very poor. Patients with limited spread of their cancer (oligometastatic disease) have a better prognosis than those with widespread disease. Recent advances in treatment therapies, including use of pre-operative immunotherapy, surgery and\u002For targeted radiation (SBRT) may help to prolong lifespan in patients with oligometastatic disease. Patients will undergo treatment for their oligometastatic esophageal or gastric cancer with pre-operative chemoimmunotherapy followed by surgery and possibly SBRT to evaluate the value of adding surgery and possibly SBRT to their treatment.",[407,408,27],"Esophageal Cancer","Gastric Cancer","2025-05-13",{"date":411,"type":35},"2025-05-16",{"date":413,"type":35},"2025-05-09",{"date":415,"type":21},"2035-05-09",{"name":417,"class":42},"University Health Network, Toronto",{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":428,"phases":4,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":100},"100508656","prospective-observational-basket-study-of-stereotactic-body-radiation-therapy-for-oligometastatic-patients-from-rare-tumors-100508656","NCT05903261","Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors","Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors: the PROMPT Study","PROMPT","Inclusion Criteria:\n\n* ECOG PS 0 - 2\n* histologically confirmed diagnosis of rare solid tumors including melanoma, soft tissue sarcoma, head-neck tumors, gynaecological tumors, Merkel cell carcinoma, thymic carcinoma, gastrointestinal stromal tumors (GIST) and urothelial tumors\n* No limit to the number of metastases treated with SBRT but all active lesions must be treated with radical intent (primary tumor and metastases)\n* Synchronous and metachronous oligometastases, as well as oligorecurrent and oligoprogressive disease are allowed\n* Ablative dose intended as a minimum dose of 50Gy EQD2\u002F10 in a maximum of 10 fractions\n* No restrictions to prior or on-going systemic therapies\n\nExclusion Criteria:\n\n* prior treatment with radiation to the same metastatic site\n* inability to provide informed consent\n* contraindications to SBRT",{"count":427,"type":21},200,"OBSERVATIONAL","This prospective observational study aims to investigate the effectiveness and safety of SBRT in the management of oligometastases from rare tumors. In addition, the study aims to identify potential differences in treatment efficacy and toxicity between different types of cancer and to provide valuable information on the use of SBRT in these contexts, potentially leading to better treatment options and outcomes for these patients.",[27],"2025-04-22",{"date":433,"type":35},"2025-04-25",{"date":435,"type":35},"2023-06-09",{"date":437,"type":21},"2026-06",{"name":439,"class":42},"Istituto Clinico Humanitas",{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":100},"100580801","feasibility-trial-of-darwin-oncotreat-and-oncotarget-precision-medicine-testing-100580801","NCT06842030","Feasibility Trial of Darwin OncoTreat and OncoTarget Precision Medicine Testing","Feasibility Trial of Darwin OncoTreat and OncoTarget Precision Medicine Testing to Improve Outcomes for Patients With Limited Metastatic Disease That Failed First-Line Systemic Therapy","Inclusion Criteria:\n\n* Patients age ≥18 years with metastatic solid tumor who are candidates for comprehensive involved site radiotherapy to all areas of disease seen on whole body imaging.\n* Patients with brain metastases are eligible provided they qualify as oligometastases (up to 10 lesions based on the SABR-COMET-10 trial) and are treatable with radiotherapy to all areas of visible disease.\n* Patients with adequate bone marrow (absolute neutrophil ≥1000, hemoglobin ≥ 9 g\u002Fdl, platelets ≥100,000), kidney (creatinine ≤1.5 times upper limit of normal) and liver (bilirubin ≤1.5 times upper limit of normal).\n* Patients being treated by radiation oncology at Good Samaritan University Hospital.\n\nExclusion Criteria:\n\n* Patients with an estimated median survival of less than 6 months using the published and validated NEAT methodology.\n* Patients who are pregnant and\u002For breast feeding or those with severe uncontrolled cardiac, pulmonary, infectious or organic brain disease.",{"count":448,"type":21},20,[24],"This is a feasibility trial to assess use of OncoTarget and OncoTreat testing in a basket design of patients with oligmetastasis across various solid tumor histology. Eligible oligometastatic patients that are receiving radiation therapy (n=20) will undergo mandatory tumor biopsy prior to precision medicine testing. Formalin fixed paraffin embedded tissue with \\>50% tumor will be sent to the Laboratory of Personalized Genomic Medicine at Columbia University Medical Center for Darwin OncoTarget and OncoTreat testing. This will be supplementing routine clinical care with the goal of improving outcomes. The treating oncologist will decide to administer standard of care systemic therapy or proceed with treatment recommended by precision medicine testing. Feasibility outcomes include the ability to have the OncoTarget and OncoTreat test performed based on tumor type and pathology, ability to procure agents, change in medication use, and identification of unknown barriers. This study is assessing the use of precision medicine in a population has documented poor outcomes with implications aimed at improving these outcomes.",[452,27,453],"Personalized Medicine","Feasibility","2025-02-18",{"date":456,"type":35},"2025-02-24",{"date":458,"type":21},"2025-03-10",{"date":460,"type":21},"2027-04-10",{"name":462,"class":42},"Good Samaritan Hospital Medical Center, New York",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":401,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":472,"briefSummary":473,"conditions":474,"keywords":477,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":282},"100566195","radiotherapy-combined-with-systemic-therapy-versus-systemic-therapy-for-oligometastatic-utucs-100566195","NCT06652022","Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic UTUCs","Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic Upper Tract Urothelial Carcinoma: a Prospective Randomised Controlled Trial","Inclusion Criteria:\n\n* Patients with metastatic uroepithelial cancer with histologically confirmed diagnosis (pathologically confirmed primary focus or one of the metastatic foci is sufficient) (metastasis after total cystectomy, metastasis after full-length nephroureteral resection, or metastatic uroepithelial cancer of the pelvic-ureteral bladder at the first diagnosis of inoperable metastatic uroepithelial cancer).\n* Oligometastases were defined as ≤3 organs, and the number and size of metastatic lesions were not restricted to the extent that full-coverage radiotherapy could be met. If regional lymph node recurrence was present, all positive regional lymph nodes were collectively referred to as one lesion. Non-regional lymph node metastases are counted as metastases by lymph node subregion.\n* Willing and able to provide written informed consent\u002Fassent for the trial; age ≥18 years on the date of signing the informed consent form and patient age ≤80 years.\n* Expected survival time ≥ 6 months;\n* Eastern Collaborative Oncology Group (ECOG) Physical Status (PS) score of 0 to 1;\n* Normal major organ function, i.e., the following criteria are met: routine blood tests: a) Haemoglobin ≥ 90 g\u002FL; b) Total bilirubin ≤ 2 x upper limit of normal (ULN); c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 2.5 x ULN in the absence of liver metastases, and ALT, AST and ALP ≤ 5 x ULN in the presence of liver metastases; d) Creatinine clearance (CrCl) ≥30 mL\u002Fmin;\n\nExclusion Criteria:\n\n* Pathological type non-urothelial carcinoma;\n* Patients with brain metastases and \\>3 liver metastases; patients with spinal bone metastases at risk of spinal cord compression; patients with pericardial, pleural or abdominopelvic fluid;\n* Patients who are intolerant to or have had a reduction in systemic therapy; patients with tumour progression assessed after 2 cycles of systemic therapy.",{"count":471,"type":21},102,[24],"This study was a prospective, open-label, phase II randomised controlled clinical study, enrolling patients with primary oligometastatic uroepithelial carcinoma, oligometastasis was defined as ≤3 organs, and the number of metastatic lesions and size of metastases were not restricted to be able to satisfy the definition of full-coverage radiotherapy, with the exception of patients with brain metastases and more than 3 liver metastases.\n\nIf regional lymph node recurrence was present, all positive regional lymph nodes were collectively referred to as one lesion. Non-regional lymph node metastases were counted as the number of metastases by lymph node subregion.\n\nPatients were divided into two groups according to whether they received radiotherapy or not: 1) systemic therapy group; 2) systemic therapy + radiotherapy group. Systemic drug therapy can be chosen from chemotherapy or immune checkpoint inhibitor therapy, or combination therapy.",[27,475,476],"Ureter Cancer","Renal Pelvic Carcinoma",[27,478,479,355,480],"Upper tract urothelial carcinoma","systematic","Randomized control trial","2024-10-20",{"date":483,"type":35},"2024-10-22",{"date":485,"type":35},"2022-01-01",{"date":487,"type":21},"2029-12-30",{"name":489,"class":42},"Peking University First Hospital",{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":499,"briefSummary":500,"conditions":501,"keywords":502,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":100},"100558855","phase-2-stereotactic-radiotherapy-for-oligometastasis-1-5-in-various-tumor-sites-vs-palliative-care-100558855","NCT06556550","Stereotactic Radiotherapy for Oligometastasis (1-5) in Various Tumor Sites vs. Palliative Care","Stereotactic Radiation Therapy for Oligometastasis (1-5) in Various Tumor Sites in Comparison to Palliative Care of Oligometastatic Tumors.","Inclusion Criteria:\n\n1. Histologically confirmed malignant formation (ICD 10-11 codes С18, С19, С20, С34, С50, С61, С64).\n2. 0-2 points on the WHO\u002FECOG scale of assessment of the general condition of the patient.\n3. The absence of disease progression after the current line of chemotherapeutic treatment.\n4. The number of oligometastases is not more than 3 in one organ, in the presence of a multi-organ lesion.\n5. The total number of distant metastases is no more than 5.\n6. Life expectancy of more than 6 months for brain metastases (GPA-score)\n7. The possibility of SBRT for all distant metastases, in accordance with the criteria specified in the study design.\n8. Making decisions on the inclusion of a patient in the study protocol based on the results of an interdisciplinary consultation consisting of an oncologist, a chemotherapist and a radiotherapist.\n9. Signed informed consent\n\nExclusion Criteria:\n\n1. 3-4 points on the WHO\u002FECOG scale of assessment of the general condition of the patient\n2. The complete response of all foci to the chemotherapy.\n3. Distant metastases only in the brain, without damage to bones and other organs.\n4. Brain metastasis of more than 3 cm in one dimension, requiring surgical treatment.\n5. Distant metastasis in the brain stem and spinal cord.\n6. The size of at least one distant metastasis is more than 5 cm.\n7. Previously performed radiation therapy on one of the metastatic foci.\n8. Metastatic lesion of the pleura, membranes of the brain or peritoneum.\n9. The impossibility of CTT for all distant metastases, in accordance with the criteria specified in the study design.\n10. Invasion into great vessels (aorta, carotid arteries, pulmonary arteries, etc.), organs of the digestive tract (esophagus, stomach, intestines), skin.\n11. Compression of the spinal cord by distant metastasis according to instrumental studies.",{"count":498,"type":21},100,[55,326],"Currently, the usual standard of palliative treatment used in patients with diagnosed oligometastatic cancer in accordance with the local clinical recommendations is chemotherapy and\u002For a symptomatic course of radiation therapy in doses less than ablative ones The aim of the study is to increase the effectiveness of treatment of patients with tumors of various localizations with oligometastases in the bones and internal organs with the help of stereotactic radiation therapy.\n\nThe method of stereotactic radiation therapy will be applied in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy treatment T1-4, N0-3, M0-1, over 18 years of age at the start of treatment, compared with standard methods of palliative therapy in those same patient models.",[27],[503,504,505,27],"stereotactic radiation therapy","stereotactic body radiation therapy","stereotactic ablative radiation therapy","2024-08-13",{"date":508,"type":35},"2024-08-16",{"date":510,"type":35},"2024-05-31",{"date":512,"type":21},"2029-12-31",{"name":514,"class":42},"National Medical Research Radiological Centre of the Ministry of Health of Russia",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":525,"briefSummary":526,"conditions":527,"keywords":531,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":100},"100466318","phase-3-metastasis-directed-therapy-for-oligorecurrent-prostate-cancer-100466318","NCT05352178","Metastasis-directed Therapy for Oligorecurrent Prostate Cancer","a New Spark in Treating Oligorecurrent Prostate Cancer: Adding Systemic Treatment to Stereotactic Body Radiotherapy or Metastasectomy: Key to Long-lasting Event-free Survival?","SPARKLE","Inclusion Criteria:\n\n* Histologically proven initial diagnosis of prostate adenocarcinoma\n* Priory treated and controlled primary tumor\n* Biochemical recurrence defined by prostate-specific antigen (PSA) values \\>0,2 ng\u002Fml (i.e., two consecutive increases) following radical prostatectomy + postoperative radiotherapy and a PSA value of 2 ng\u002Fml above the nadir after high-dose RT.\n* Oligorecurrent disease defined as a maximum of 5 extracranial metastases in any organ, diagnosed on PSMA PET-CT or PSMA PET-MRI reported according to the E-PSMA consensus guidelines for interpretation of PSMA-PET (26). Nodal (N1) disease can be included only when accompanied by M1a-c disease, provided that the total number of spots does not exceed 5.\n* Serum testosterone level within normal range.\n* WHO performance 0-2\n* Age \\>= 18 years old\n* Absence of psychological, sociological or geographical condition potentially hampering compliance with study protocol.\n* Patients must be presented at the multidisciplinary board meeting and the inclusion in the trial needs approval by this board.\n* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n* 2\\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n\nExclusion Criteria:\n\n* Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol\n* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial\n* Participation in an interventional Trial with an investigational medicinal product (IMP) or device\n* Serum testosterone level at castration level.\n* PSA rise while on active treatment (LHRH-agonist, LHRH antagonist, anti-androgen, maximal androgen blockade, oestrogen)\n* Presence of poly-metastatic disease, defined as more than 5 metastatic lesions.\n* Active malignancy other than prostate cancer that could potentially interfere with the interpretation of this trial.\n* Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible.\n* Contra indications for intake of enzalutamide (seizure or any condition that may predispose to seizure; significant cardiovascular disease within the last three months including myocardial infarction, unstable angina, congestive heart failure, ongoing arrythmias of grade \\> 2 or a thromboembolic event).\n* Not able to understand the treatment protocol or sign informed consent.",{"count":524,"type":21},873,[326],"The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and\u002For metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.",[58,528,529,223,27,167,530],"Prostate Cancer Recurrent","Prostate Cancer Metastatic","Hormone Sensitive Prostate Cancer",[532,533,534,535],"Androgen deprivation therapy","Androgen receptor targeted agent","Stereotactic body radiation therapy","Metastasis-directed therapy","2024-07-01",{"date":538,"type":35},"2024-07-03",{"date":540,"type":35},"2022-04-20",{"date":542,"type":21},"2032-04-25",{"name":544,"class":42},"Universitaire Ziekenhuizen KU Leuven",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":401,"enrollmentInfo":552,"targetDuration":554,"studyType":428,"phases":4,"briefSummary":555,"conditions":556,"keywords":559,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":578,"leadSponsor":580,"locationsCount":4},"100549161","outcomes-of-local-treatment-for-oligometastatic-prostate-cancer-diagnosed-using-psma-pet-imaging-oligomet-study-100549161","NCT06430411","Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study","OLIGOMET","Inclusion Criteria:\n\n* Oligometastatic prostate cancer diagnosed using PSMA PET defined as cM1a and\u002For cM1b with ≤5 osseous metastases and\u002For M1c with ≤3 lung lesions, with or without cN positivity.\n* Oligometastatic prostate cancer treated with primary local therapy such as radical prostatectomy or radiation therapy.\n* Any Gleason Score, any cT stage, any PSA\n\nExclusion Criteria:\n\n* Visceral metastases (apart from lungs).\n* Neoadjuvant therapy prior to first PSMA PET.\n* Non-metastatic prostate cancer.\n* Patients who did not undergo imaging before local treatment.",{"count":553,"type":21},500,"5 Years","PSMA-PET\u002FCT or PSMA-PET\u002FMRI are more accurate imaging modalities compared to CT\u002FBS; in approximately 10-20% of high-risk patients diagnosed using conventional imaging PSMA-PET up-stages the disease. Therefore a substantial proportion of high-risk patients previously considered as non-metastatic are expected to be diagnosed with oligometastatic disease. While standard treatment pathways exist for patients with non-metastatic or oligometastatic disease confirmed using conventional imaging, less is known about the optimal management of patients with oligometastatic prostate cancer on PSMA-PET.\n\nCurrently, data on the safety, effectiveness and oncologic outcomes of local therapies in oligometastatic patients diagnosed using PSMA-PET have been poorly reported so far. Thus, there is a need for a prospectively maintained database to collect real-world clinical data to produce high-quality research on the optimal management in oligometastatic prostate cancer who underwent PSMA-PET for primary staging and subsequent local therapy. This database will allow centers to retro- and prospectively collect data to facilitate analysis and assessment of the outcomes of oligometastatic patients managed with local therapy.",[529,557,58,558,27,167],"Prostate Cancer Metastatic to Bone","Prostate Neoplasm",[560,561,562,563,564,565,566,567,568,569,570,571,572,573],"prostate","oligometastatic","oligometastasis","oligomet","prostatectomy","irradiation","abiraterone","enzalutamide","darolutamide","apalutamide","androgen deprivation therapy","ADT","docetaxel","PSMA PET","2024-05-24",{"date":576,"type":35},"2024-05-28",{"date":510,"type":21},{"date":579,"type":21},"2031-12-31",{"name":581,"class":42},"Medical University of Vienna",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":592,"conditions":593,"keywords":595,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":100},"100530745","phase-3-local-therapy-for-oligometastatic-escc-patients-treated-with-pd-1-inhibitor-100530745","NCT06190782","Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor","Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* 1\\. ≥18 years old; 2. ECOG 0-1; 3. Esophageal squamous cell carcinoma 4. ASTRO\u002FESTRO defined genuine oligometastatic disease and consistent with: i. ≤4 distant metastases, ii. ≤3 metastatic lesions within a single organ, iii. maximum diameter of each metastatic lesion ≤5cm; 5. ≥1 pathologically diagnosed metastases\n\nExclusion Criteria:\n\n* 1\\. History of disseminated metastases or ASTRO\u002FESTRO defined induced oligometastatic disease 2.Esophageal perforation\u002Fhemorrhage 3.Progression disease after PD-1 inhibitor treatment 4.In-field recurrence 5.Intolerance to chemotherapy or immunotherapy 6.lung V20\\>25%",{"count":590,"type":21},354,[326],"Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +\u002F- chemotherapy combined with local therapy or PD-1 inhibitor +\u002F- chemotherapy alone.\n\nThe primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.",[594,27,221],"Esophageal Squamous Cell Carcinoma",[596,597,221,598],"esophageal squamous cell carcinom","Oligometastatic","pd-1 inhibitor","2024-04-30",{"date":601,"type":35},"2024-05-02",{"date":603,"type":35},"2022-09-27",{"date":605,"type":21},"2027-09-27",{"name":607,"class":42},"Fudan University",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":614,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":22,"phases":618,"briefSummary":619,"conditions":620,"keywords":625,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":637,"leadSponsor":639,"locationsCount":641},"100543508","longitudinal-study-of-local-ablative-therapy-in-oligometastatic-disease-100543508","NCT06356779","Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease","A National Longitudinal Study of Metastases-directed Local Ablative Therapy for Patients With Oligometastatic Disease - a Combined Interventional and Observational Trial","OLIGO-DK","Inclusion Criteria:\n\n* Histology or cytology proven non-haematological cancer\n* Stage IV disease\n* ECOG performance status ≤ 2\n* Life expectancy \\> 6 months\n* A baseline scan within 42 days of inclusion (PET-CT or CT or MRI scan) is required, preferably within 28 days for optimal prospective evaluation\n* Primary tumor must be controlled, defined by the radiographical response of the primary tumor by systemic or local treatment. If progressing, it is planned to be treated with local ablative therapy (LAT)\n* Oligometastatic disease according to the ESTRO-EORTC classification, both de-novo and induced, including oligoprogression\n* A maximum of five oligometastases or oligopersistent\u002Foligoprogressive lesions. More than five metastases are allowed in the following cases, 1) location in a defined anatomical entity or 2) location in immediate proximity and as such, cannot be treated separately\n* All oligometastatic lesions must be planned for definitive LAT. If all visible\u002Fprogressive\u002Fpersistent disease is not treated, the patient cannot be included\n* Local ablative therapy must be deemed clinically relevant for the individual patient by the treating team of physicians, or a multidisciplinary team and discussion must be documented in the patient chart\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Pregnancy\n* Diffuse cancer disease, which cannot be locally ablated, i.e., leptomeningeal carcinomatosis, malignant pleural effusions, lymphangitic carcinomatosis, or peritoneal carcinomatosis\n* If LAT is deemed unsafe by the MDT (e.g., tumor perforation of hollow organs)\n\nIn addition, the patients receiving SBRT to oligometastatic sites should comply with the following criteria.\n\n* The size of the target is limited by the ability to safely deliver locally ablative doses to the metastatic lesions. Generally, an upper limit of 5 cm is recommended\n* If the patient has received previous radiotherapy, the combined dose at the radiation site must not exceed the dose constraints according to Appendix 2 - Radiotherapy Recommendations",{"count":617,"type":21},1200,[24],"This prospective national multicenter observational and interventional study aims to assess the longitudinal disease trajectory of patients with oligometastatic disease (OMD) who receive local metastasis-directed therapy. Patients with any category of OMD from any non-hematological cancer are eligible for inclusion. Local ablative therapy (LAT) includes surgical metastasectomy, radiotherapy, thermal ablation, and electroporations.\n\nThe primary objective is to assess the time to failure of LAT strategy in patients with OMD from any primary cancer treated with all LAT modalities.",[27,621,622,221,623,624],"Metastases","Ablation Techniques","Stereotactic Radiation","Surgery",[626,627,628,629,630,631,632],"oligometastatic disease","metastases-directed therapy","metastasectomy","thermal ablation","stereotactic ablative radiotherapy","stereotactic radiosurgery","endpoints","2024-04-15",{"date":635,"type":35},"2024-04-16",{"date":633,"type":35},{"date":638,"type":21},"2035-12-31",{"name":640,"class":42},"Gitte Fredberg Persson MD PhD",11,{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":648,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":650,"enrollmentInfo":651,"targetDuration":4,"studyType":22,"phases":653,"briefSummary":654,"conditions":655,"keywords":663,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":676,"locationsCount":100},"100525435","phase-2-radiotherapy--chemoimmunotherapy-followed-by-surgery-in-patients-with-limited-metastatic-gastric-or-gej-cancer-100525435","NCT06121700","Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer","Radiotherapy, Chemotherapy and Anti-PD-1 Immunotherapy Followed by Surgical Resection in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Single Arm, Phase II Trial","Miracle-G","Inclusion Criteria:\n\n1. Histopathologically confirmed adenocarcinoma of stomach (G) or gastroesophageal junction (GEJ) (excluding Siewert type I).\n2. Limited metastatic status of disease.\n3. At least one evaluable lesion in CT\u002FMRI according to RESIST 1.1 is required.\n4. The status of HER2 is clear.\n5. pMMR\u002FMSS confirmed by immunohistochemistry or gene test.\n6. Male or female. Patient age ≥ 18 years and ≤ 75 years.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.\n8. Physical state or organ function can tolerate the planned treatment of the study protocol, including systematic chemotherapy, immunotherapy with anti-PD-1 monoclonal antibody (mAb), primary lesion radiotherapy, metastatic lesion radiotherapy, and surgical resection of primary and\u002For metastatic lesions.\n9. No previous surgery or antitumor therapies, including chemotherapy, radiotherapy, or immunotherapy, were administered.\n10. Adequate hematological function: absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; platelet count ≥ 100×109\u002FL; hemoglobin level ≥ 90 g\u002FL.\n11. Adequate hepatic function: total bilirubin ≤ 1.5×upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \\\u003C 2.5 × ULN in the absence of liver metastases, or \\\u003C 5 × ULN in case of liver metastases; ALP ≤ 2.5×ULN; ALB ≥ 30 g\u002FL.\n12. Adequate renal function: serum creatinine ≤ 1.5×ULN; creatinine clearance rate ≥ 60 ml\u002Fmin.\n13. Adequate coagulation function: INR\u002FPT ≤ 1.5×ULN; APTT ≤ 1.5×ULN.\n14. TSH is within the normal range; if TSH is out of the normal range, FT3 and FT4 should be investigated. If the test results of FT3\u002FFT4 cannot be obtained, T3 and T4 can be accepted. 13. If the level of T3\u002FT4 is normal, the patients can be selected.\n15. Urine test: urine protein\\\u003C2+; if the urine protein≥2+, the 24-hour urine protein quantification must be≤1g.\n16. There is no serious concomitant disease, and the patient's life expectancy is more than 6 months.\n17. Patients agree to sign written informed consent before recruitment.\n18. Patients are willing and able to follow the protocol during the study, including receiving treatment and scheduled follow-up and examination.\n19. Patients are willing to provide samples of blood and tissue.\n20. Female patients should not be pregnant or breast feeding.\n21. Female patients agree to take contraceptive measures during treatment and within 120 days after the last dose of anti-PD-1 mAb or 180 days after the last use of chemotherapy or radiotherapy.\n\nDefinition of the limited metastatic disease:\n\n1. Retroperitoneal lymph node metastases (RPLM) only or at maximum one organ involved with or without RPLM.\n2. There is no peritoneal seeding on diagnostic laparoscopy (P0).\n3. The definition of RPLM includes but is not limited to para-aortal, intra-aorto-caval, parapancreatic or mesenteric lymph nodes. If the duodenum is invaded, retropancreatic nodes are not regarded as M1.\n4. The definition of single organ metastasis in the study is as follows: a) Liver: maximum of 5 metastatic lesions that are potentially resectable and the metastases should be limited to one lobe and not involve important blood vessels or bile ducts. b) Lung: unilateral involvement, potentially resectable. c) Ovary: uni- or bilateral Krukenberg tumors in the absence of macroscopic peritoneal carcinomatosis. d) Adrenal gland: uni- or bilateral metastases. e) Extra-abdominal lymph node metastases, such as supraclavicular or cervical lymph node involvement. f) Bone: localized bone involvement (defined as being within one radiation field).\n5. Other metastatic disease locations are considered, limited by the investigator and confirmed by the multidisciplinary team (MDT).\n\nExclusion Criteria:\n\n1. Patients who have previously received surgery, chemotherapy, radiotherapy or immunotherapy for gastric cancer.\n2. Patients have a history of cancer in the five years before enrollment except for squamous or basal cell carcinoma of the skin that was effectively treated and superficial bladder cancer, cervical carcinoma in situ and breast cancer in situ that was treated by operation.\n3. Pregnant or lactating females or females planning to become pregnant or lactating. Women of childbearing age with a positive pregnancy test or without a pregnancy test in the baseline period. Menopausal women must have stopped menstruating for at least 12 months before being considered to have no chance of pregnancy.\n4. Patients who had sexual activity (with the possibility of childbirth) and were unwilling to use contraception during the study period.\n5. Patients with a history of allergies to any drugs that may be used in this study, including chemotherapy drugs.\n6. History of allogeneic stem cell transplantation or organ transplantation.\n7. Vaccinated with live vaccine within 28 days before recruitment.\n8. Immunotherapy (interleukin, interferon, thymine) or other experimental treatment was given 28 days before enrollment.\n9. History of anti-PD-1, PD-L1, PD-L2 or any other specific T-cell costimulation or checkpoint pathway targeted therapy.\n10. History of using steroids (dose \\> 10 mg\u002Fd prednisone) or other systemic immunosuppressive therapy within 14 days before recruitment, except for patients treated with the following regimen: steroids used for hormone replacement (dose \\> 10 mg\u002Fd prednisone); local application of steroids with little systemic absorption; short-term (≤ 7 days) use of steroids to prevent allergy or vomiting.\n11. Patients with weight loss of more than 20% within 2 months before recruitment.\n12. Uncontrolled systemic diseases, including diabetes, hypertension, etc.\n13. Uncontrollable pleural effusion, pericardial effusion, or ascites occurred within two weeks before recruitment.\n14. Failure of important organs (heart, lung, liver, kidney, etc.).\n15. Moderate or severe renal injury \\[creatinine clearance ≤ 50 ml\u002Fmin (according to Cockcroft \\& Gault equation)\\], or SCR \\> ULN.\n16. Dipyrimidine dehydrogenase (DPD) deficiency.\n17. Patients with central nervous system (CNS) disorders or tumors, including brain metastases, peripheral nervous system disorders or psychiatric diseases.\n18. Cerebrovascular accidents occurred within 6 months before recruitment.\n19. Patients with peripheral neuropathy of NCI-CTCAE grade 1, except for those with disappearance of the deep tendon reflex.\n20. Patients with a known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, congestive heart failure, cardiac infarction or cardiac insufficiency within 6 months prior to study recruitment.\n21. Pulmonary embolism occurred within 28 days before enrollment.\n22. Patients who had the following history of pulmonary diseases: interstitial lung disease, noninfectious pneumonia, pulmonary fibrosis, or acute lung disease.\n23. Patients with gastrointestinal bleeding or a high risk of bleeding within the first 2 weeks of enrollment.\n24. Patients who experienced gastrointestinal perforation or fistula within 6 months prior to enrollment.\n25. Upper gastrointestinal obstruction, dysfunction or malabsorption syndrome may affect the absorption of oral chemotherapy drugs.\n26. Patients who cannot swallow or take medication orally.\n27. Patients with a history of active autoimmune disease or refractory autoimmune disease.\n28. Severe chronic or active infections requiring systemic antibiotics, antifungal or antiviral therapy, including tuberculosis and AIDS.\n29. Known history of human immunodeficiency virus (HIV) infection.\n30. Patients with untreated chronic hepatitis B or HBV-DNA exceeding 500 IU\u002Fml or HCV-RNA positive.\n31. Alcohol\u002Fdrug abuse and medical, psychological or social conditions may interfere with patients' participation in the study or have an impact on the evaluation of the study results.","75 Years",{"count":652,"type":21},55,[55],"The goal of this clinical trial is to evaluate the efficacy and safety of radiotherapy combined with chemotherapy and anti-PD-1 immunotherapy followed by surgery for the primary and metastatic lesions in patients with limited metastatic gastric or gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies will improve the survival of this group of patients. 2) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies can be performed safely in this group of patients.\n\nParticipants will receive short course hypofractionated radiotherapy (HFRT) for the primary lesion, HFRT or stereotactic body radiotherapy (SBRT) for metastatic lesions, combined with systemic chemotherapy and anti-PD-1 immunotherapy. For patients with HER2-positive cancer (defined as IHC 3+ or 2+\u002FISH+), trastuzumab is used along with chemotherapy and anti-PD-1 antibody. Then, surgical resections of primary and metastatic lesions are performed as much as possible. For patients who need a widely invasive surgical approach or are inoperable, local ablative therapies such as radiofrequency ablation (RFA) and microwave ablation (MVA) can be alternatives. For patients undergoing surgical resections, postoperative treatment includes chemotherapy, which is determined by the researcher, and PD-1 antibody, which will be maintained until one year after surgery.",[656,657,658,27,223,659,660,661,662],"Adenocarcinoma","Stomach Neoplasm","Gastroesophageal-junction Cancer","Metastatic Gastric Cancer","Adenocarcinoma of the Stomach","Gastroesophageal Junction Adenocarcinoma","Metastatic Adenocarcinoma",[664,665,562,666,667,668,669,628],"gastric cancer","GEJ Cancer","limited metastatic","hypofractionated radiotherapy","immunotherapy","gastrectomy","2023-11-07",{"date":672,"type":35},"2023-11-08",{"date":674,"type":35},"2023-01-01",{"date":256,"type":21},{"name":607,"class":42},{"id":678,"slug":679,"hasResults":12,"nctId":680,"briefTitle":681,"officialTitle":682,"acronym":4,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":684,"targetDuration":4,"studyType":22,"phases":686,"briefSummary":687,"conditions":688,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":100},"100509745","phase-2-phase-2-study-of-sbrt-plus-tislelizumab-and-regorafenib-in-unresectable-or-oligometastatic-hcc-100509745","NCT05917431","Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC","Phase 2 Study of Stereotactic Body Radiation Therapy Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic Hepatocellular Carcinoma","Inclusion Criteria:\n\n* age ≥ 18 years\n* Eastern Cooperative Oncology Group performance status of 0-1\n* clinical or pathological diagnosis of HCC\n* with unresectable locally advanced or oligometastatic HCC (metastatic lesions ≤ 5, metastatic organs ≤ 3, may involve extrahepatic lymph nodes or distant organs apart from brain)\n* at least one measurable lesion according to mRECIST criteria\n* all lesions could be included in radiation target volume\n* Child-Pugh A or B (7 scores) liver function\n* patients are allowed to receive systemic therapy previously other than tislelizumab plus regorafenib\n* adequate hematological and renal function\n* life expectancy ≥ 3 months；\n* willing to participate in the study and give written informed consent\n\nExclusion Criteria:\n\n* a history of liver transplantation\n* with severe cirrhosis complications, including a history of esophagogastric variceal bleeding, hepatic encephalopathy, and massive ascites\n* with active autoimmune diseases or a history of autoimmune disease\n* with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)\n* allergic to the ingredient of tislelizumab or regorafenib\n* with recurrent lesions treated with radiotherapy previously\n* prescribed radiation does could not be delivered due to dose limits to organs at risk (OAR)\n* intolerable to radiation or systemic treatment because of cardiac insufficiency, uncontrolled high blood pressure\n* a history of other malignancies, except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix",{"count":685,"type":21},39,[55],"The goal of this phase 2 prospective clinical trial is to learn about the efficacy and safety of stereotactic body radiation therapy (SBRT) plus immunotherapy and targeted therapy in patients with unresectable or oligometastatic hepatocellular carcinoma (HCC).\n\nThe main question to answer is: Whether combing SBRT with immunotherapy and targeted therapy could prolong PFS. Participants will receive SBRT to all visible lesions and concurrent systemic immunotherapy and targeted therapy.",[689,27],"Unresectable Hepatocellular Carcinoma","2023-06-15",{"date":692,"type":35},"2023-06-23",{"date":694,"type":21},"2023-06",{"date":696,"type":21},"2026-12-30",{"name":698,"class":42},"Peking University Cancer Hospital & Institute"]