[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centre Antoine Lacassagne\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":359},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,45,68,86,109,139,165,184,208,229,258,282,304,332],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100643662","phase-4-pharmacokinetic-study-of-pembrolizumab-and-its-impact-on-immunity-and-the-tumor-microenvironment-which-may-explain-the-efficacy-of-post-immunotherapy-chemotherapy-100643662",false,"NCT07633613","Pharmacokinetic Study of Pembrolizumab and Its Impact on Immunity and the Tumor Microenvironment, Which May Explain the Efficacy of Post-immunotherapy Chemotherapy.","CPI","Inclusion Criteria:\n\n\\- Patients over 18 years of age\n\n\\- Patients diagnosed with :\n\n1. Non-small cell lung cancer (NSCLC), including adenocarcinoma and squamous cell carcinoma.\n2. Head and neck squamous cell carcinoma, p16-negative for oropharyngeal tumors.\n\n   * Recurrent and\u002For metastatic tumor not amenable to curative locoregional treatment.\n   * Disease progression under Pembrolizumab immunotherapy, administered at the standard dose of 200 mg every 3 weeks, as first-line treatment for metastatic disease, regardless of the number of cycles received, either as monotherapy or in combination with chemotherapy, as defined below:\n\n     • For pulmonary adenocarcinomas: i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin or Cisplatin) and Pemetrexed\n\n   ii. Maintenance therapy with Pembrolizumab, with or without Pemetrexed.\n\n   • For pulmonary squamous cell carcinomas: i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin) and Paclitaxel\n\n   +\u002F- ii. Maintenance therapy with Pembrolizumab alone.\n\n   • For head and neck squamous cell carcinomas : i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin or Cisplatin) ± 5-Fluorouracil (5-FU) or Paclitaxel\n\n   +\u002F- ii. Maintenance therapy with Pembrolizumab alone.\n   * Eligibility for salvage chemotherapy within standard care:\n\n     • For pulmonary adenocarcinomas: weekly Paclitaxel, with or without Bevacizumab.\n     * For pulmonary squamous cell carcinomas: Gemcitabine monotherapy.\n     * For head and neck squamous cell carcinomas: weekly Paclitaxel and\u002For Cetuximab. Standard salvage chemotherapy may be initiated between Day 18 and Day 35 following the last Pembrolizumab injection, at standard doses.\n   * Measurable disease according to RECIST 1.1 criteria.\n   * Performance status (PS) 0 to 2.\n   * Baseline laboratory results meeting the usual criteria permitting initiation of salvage chemotherapy.\n   * Patients who has voluntarily agreed to participate in the study (including additional blood sampling) and has signed the informed consent form.\n   * For the subpopulation with accessible tissue biopsy:\n\n     * Patient agrees to undergo biopsy,\n     * INR \\\u003C 1.5, Platelets \\> 50000\u002FμL.\n   * Patients covered by a social security health insurance scheme.\n\n   Exclusion Criteria:\n   * History of cancer, except for cancers in complete remission for more than 3 years, fully resected cutaneous basal cell carcinomas, or treated carcinoma in situ or cervical intraepithelial neoplasia (in situ cervical epithelioma),\n   * Patients participating in another clinical trial for which an exclusion period is specified,\n   * Minor patients,\n   * For the subpopulation with accessible tissue biopsy, patients receiving:\n\n     • Clopidogrel (hydrogen sulfate) or Prasugrel (hydrochloride) or Ticlopidine (hydrochloride) without the possibility of discontinuation for 5 days,\n\n     • Low-molecular-weight heparin (LMWH) without the possibility of dose suspension prior to the procedure,\n\n     • Or Fondaparinux without the possibility of discontinuation,\n\n     • Or Abciximab without the possibility of discontinuation for 24 hours and aPTT \\\u003C 50s and ACT \\\u003C 150s,\n\n     • Or Eptifibatide or Tirofiban hydrochloride monohydrate or Argatroban without the possibility of discontinuation 4 hours before the procedure,\n     * Or Bivalirudin without the possibility of discontinuation 2-3 hours before the procedure if CrCL \\> 50 mL\u002Fmin, or 3-5 hours if CrCL \\\u003C 50 mL\u002Fmin,\n     * Or Dabigatran etexilate without the possibility of discontinuation 2-3 days before the procedure if CrCL \\> 50 mL\u002Fmin, or 3-5 days if CrCL \\\u003C 50 mL\u002Fmin.\n   * Vulnerable persons as defined in Articles L1121-5 to L1121-8 :\n\n     • Pregnant women, women in labour, and breastfeeding mothers,\n     * Persons deprived of liberty by judicial or administrative decision, and persons hospitalized without consent under Articles L3212-1 and L3213-1 who do not fall under the provisions of Article L1121-8,\n     * Persons admitted to a health or social care institution for purposes other than research,\n     * Adults under legal protection measures or unable to express their consent.","ALL","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This is a single-center pharmacokinetic study evaluating the impact of residual pembrolizumab levels on the efficacy of salvage chemotherapy following immunotherapy in patients with non-small cell lung cancer (NSCLC) or recurrent and\u002For metastatic head and neck squamous cell carcinoma (HNSCC) not amenable to curative local treatment.",[26,27],"Non-Small Cell Lung Carcinoma (NSCLC)","Metastatic Head and Neck Squamous Cell Carcinoma",[29,30,31,32],"Pembrolizumab","immunotherapy","salvage chemotherapy","pharmacokinetics","NOT_YET_RECRUITING","2026-06-04",{"date":36,"type":37},"2026-06-08","ACTUAL",{"date":39,"type":20},"2026-07",{"date":41,"type":20},"2028-12",{"name":43,"class":44},"Centre Antoine Lacassagne","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100580125","prospective-cohort-study-evaluating-18fdg-pet-ct-for-the-early-prediction-of-the-efficacy-of-immunotherapy-associated-or-not-with-chemotherapy-in-patients-with-locally-advanced-or-metastatic-non-small-cell-broncho-pulmonary-carcinoma-100580125","NCT06833229","Prospective Cohort Study Evaluating 18FDG PET-CT for the Early Prediction of the Efficacy of Immunotherapy Associated or Not With Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Broncho-Pulmonary Carcinoma","FDG Immun Comb","Inclusion Criteria:\n\n* Age greater than or equal to 18 years,\n* Patients with histologically proven, metastatic or locally advanced NSCLC, with indication for immunotherapy (Nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab), in combination or not with chemotherapy molecules (carboplatin, cisplatin, pemetrexed, paclitaxel or nab-paclitaxel), validated by a Multidisciplinary Team and prescribed within the scope of their Marketed Authorization, whatever the line of treatment treatment line,\n* ECOG 0 to 3,\n* The patient's understanding of the protocol and the note of non-opposition, with oral agreement,\n* Patient has not objected to the use of his or her data for medical research. research,\n* Patient has social security coverage.\n\nExclusion Criteria:\n\n* Age under 18,\n* Contraindication to 18FDG PET-CT examinations: severe claustrophobia, unbalanced diabetes at the time of the first PET-CT scan (fasting capillary glucose ≥ 11 mmol),\n* Hemoglobin less than 7 g\u002FdL at inclusion. If the patient has a respiratory or or cardiovascular pathology, hemoglobin must not be less than 9.0 g\u002FdL,\n* Any participation in other biomedical studies involving the drug, medical devices or medical devices or imaging techniques is prohibited, with the exception of biomedical studies,\n* Refusal to participate in the present study,\n* Contraindication (e.g. hypersensitivity to the active substance or to one of the excipients of immunotherapy or chemotherapy treatments...).\n* Vulnerable persons are defined in article L1121-5 to -8:\n\n  * Pregnant women, parturients and nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of the provisions of article L. 1121-8,\n  * and persons admitted to a health or social establishment for purposes other than research purposes,\n  * adults who are the subject of a legal protection measure, or who are unable to exercise their non opposition",{"count":53,"type":20},200,"OBSERVATIONAL","The hypothesis of this prospective observational pilot study of diagnostic diagnostic performance is that, for patients with NSCLC treated with immunotherapy associated or not with chemotherapy, certain metabolic biomarkers on 18FDG PET scans allow early identification of treatment response (or lack of response to treatment) and optimize prediction of tumor response compared with current standards.",[57],"Carcinoma, Non-Small-Cell Lung (NSCLC)","RECRUITING","2026-05-27",{"date":61,"type":37},"2026-05-29",{"date":63,"type":37},"2022-01-27",{"date":65,"type":20},"2031-01-27",{"name":43,"class":44},1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":67},"100581566","research-into-biomarkers-predictive-of-survival-and-response-to-cancer-treatment-100581566","NCT06851975","Research Into Biomarkers Predictive of Survival and Response to Cancer Treatment","BEST","Inclusion Criteria:\n\n* Patient having a blood test, venous line insertion or injection on an implantable venous device scheduled as part of their standard care,\n* Patient who has read the information note and stated that he\u002Fshe has no objections\n* Patient who has not objected to the use of this data for medical research purposes\n* Patient with social security cover.\n\nExclusion Criteria:\n\n* Patient already included in the study\n* Patient considered to be a vulnerable person; vulnerable persons are defined in article L1121-5 to -8",{"count":76,"type":20},40000,"Research into biomarkers predictive of survival and response to cancer treatment",[79],"Cancer",{"date":61,"type":37},{"date":82,"type":37},"2020-01-07",{"date":84,"type":20},"2099-12-31",{"name":43,"class":44},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":17,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":67},"100434220","virtual-reality-for-children-in-radiotherapy-rever-100434220","NCT04934293","Virtual Reality for Children in Radiotherapy (REVER)","REVER","Inclusion Criteria:\n\n* Patient treated at the Antoine LACASSAGNE Center for treatment by proton therapy\n* Age ≥ 7 years old and ≤ 18 years old\n* Patient, and parents for minor children, having read the information notice and signed the informed consent,\n* Patient with social security coverage.\n\nExclusion Criteria:\n\n* Age \\\u003C 7 years old and \\> 18 years old,\n* Patient under general anesthesia,\n* Patient suffering from wounds or infections in the head, deemed incompatible with the use of the helmet by the investigator,\n* Patient suffering from respiratory problems,\n* Patient suffering from a high level of claustrophobia,\n* Patient followed for a psychiatric pathology,\n* Patient suffering from unbalanced epilepsy,\n* Patient suffering from visual (binocular vision) and \u002F or hearing disorders preventing the use of virtual reality,\n* Patient whose head circumference is insufficient for the use of the helmet, deemed incompatible with the use of the helmet by the investigator,\n* Patient treated by radio chemotherapy.","7 Years",{"count":95,"type":20},47,[97],"NA","For a young patient, the conditions of proton therapy treatment can be stressful. Adjusting the environment can be a source of avoiding this physical and psychological discomfort impacting the quality of treatment.\n\nA fixed, long, uncomfortable position is the main cause of stress, already present due to the cancerous therapeutic course. It extends the positioning time. For the patient and the optimization of his treatment, solutions must be sought.\n\nRelaxation in virtual reality is efficient, simple and non-medicinal and could reduce stress in children and allow irradiation in very good conditions.\n\nWe will assess the effectiveness of the virtual reality session using objective (placement time, helmet tolerance) and subjective (perceived anxiety via a dedicated questionnaire) criteria. This is the first pediatric virtual reality study, supported by the French Group of Pediatric Radiotherapists, to reduce anxiety in radiotherapy.\n\nMultiple benefits from this pilot study are expected, such as improved reception conditions, treatment parameters and better acceptance of proton therapy sessions.",[100,101,102],"Virtual Reality","Proton Therapy","Pediatric Cancer",{"date":61,"type":37},{"date":105,"type":37},"2021-08-02",{"date":107,"type":20},"2027-02",{"name":43,"class":44},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":120,"conditions":121,"keywords":127,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":67},"100625965","assessment-of-adherence-to-remotely-monitored-physical-activity-tracked-on-a-smartwatch-and-its-impact-on-reducing-fatigue-3-months-after-adjuvant-chemotherapy-for-cancer-100625965","NCT07429487","Assessment of Adherence to Remotely Monitored Physical Activity Tracked on a Smartwatch, and Its Impact on Reducing Fatigue 3 Months After Adjuvant Chemotherapy for Cancer","WATCH AND ACT","Inclusion Criteria:\n\n1. Patients aged 18 to 75 years old,\n2. Histologically proven non-metastatic adenocarcinoma of breast, colorectal, ovarian, pancreatic, biliary, or gastric origin,\n3. Adjuvant chemotherapy completed less than 3 months ago (excluding hormone therapy),\n4. PS 0 or 1 according to the World Health Organization (WHO) scale,\n5. No recurrence since the end of adjuvant chemotherapy,\n6. Patient who has voluntarily agreed to participate in the study and sign the written informed consent form,\n7. Patient affiliated with a Social Security scheme.\n\nExclusion Criteria:\n\n1. New cancer treatment planned (excluding hormone therapy),\n2. Patient who has received adjuvant immunotherapy,\n3. Cardiological contraindication to the program\n4. Decompensated or unstable chronic conditions\n5. Severe malnutrition\n6. Rheumatological unfitness as determined by the oncologist,\n7. Chronic respiratory failure requiring long-term O2 therapy\n8. Diabetes with plantar ulceration\n9. Progressive or chronic non-healing bedsore\u002Fwound\n10. Recent unhealed fracture\n11. Patient participating in another interventional clinical study at the time of signing the informed consent form.\n12. Vulnerable persons as defined in Articles L1121-5 to -8","75 Years",{"count":118,"type":20},98,[97],"A single-center, randomized (1:1) open-label, prospective, stratified study with two parallel arms, designed to evaluate adherence to the adapted physical activity (APA) program for patients participating in an APA program and to compare changes in fatigue at 3 months in patients who have completed adjuvant systemic chemotherapy for cancer and are participating in an APA program.",[122,123,124,125,126],"Breast Cancer","Colorectal Cancer","Ovarian Adenocarcinoma","Pancreatic Cancer","Gastric Adenocarcinoma",[128,129,130],"adapted physical activity","fatigue","completed adjuvant systemic chemotherapy for cancer","2026-02-17",{"date":133,"type":37},"2026-02-24",{"date":135,"type":20},"2026-06-15",{"date":137,"type":20},"2030-06-15",{"name":43,"class":44},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":147,"minAge":148,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},"100414753","phase-2-per-operative-radiotherapy-by-papillon-tm-in-localized-breast-cancer-100414753","NCT04680715","Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer","Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study","RPOS+2","Inclusion Criteria:\n\n* Patient with invasive ductal adenocarcinoma \\\u003C=2cm, evaluate on all radiological exams;\n* Women aged 65 years or older (patients 65 years of age in the year may be included);\n* Grade 1 or 2 unifocal adenocarcinoma, all index KI67, positive HR, negative HER2 status;\n* T0 or T1, N0 radio-clinic;\n* Operable patient with breast volume compatible with conservative surgery;\n* Patient with prior malignancy or other concurrent malignancies are eligible, including bilateral breast cancer\n* Patients who have been made aware of the information sheet and have given their written signed informed consent;\n* Patients benefitting from social health insurance coverage\n\nExclusion Criteria:\n\n* Age less than 65 years (except if 65 years obtained during the year)\n* Patient with an exclusive in situ carcinoma\n* Patient with lymphatic invasion \u002F peri-nerve involvement \u002F vascular emboli\n* Patient with a lobular adenocarcinoma\n* Patient with metastatic disease\n* Multifocal tumor\n* Patient with grade 3 or N+ disease\n* N1 proved by ultrasound guided\n* patient unable to express her consent\n* Patient deprived placed under the authority of a tutor\n* Female patients who are pregnant or breastfeeding\n* Vulnerable patient: as defined in article L1121-5 à -8","FEMALE","65 Years",{"count":150,"type":20},40,[152],"PHASE2","Phase II study; open recruitment, multicentrique. The aim of this clinical research is to evaluate faisability and toxicity of the per-operative radiotherapy using PAPILLON + TM device for localized breast cancers patients over 65 years.",[155],"Localized Breast Cancer","2026-01-28",{"date":158,"type":37},"2026-01-29",{"date":160,"type":37},"2021-07-16",{"date":162,"type":20},"2028-06",{"name":43,"class":44},2,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":67},"100621935","metabolomics-of-cancers-of-the-upper-aerodigestive-tract-100621935","NCT07377084","Metabolomics of Cancers of the Upper Aerodigestive Tract","METABORL","Inclusion Criteria:\n\n* Histologically proven squamous cell carcinoma of the upper aerodigestive tract (oral cavity, oropharynx, larynx, and hypopharynx), stage T1-4, N0-3, M0, untreated.\n* Curative treatment planned at CAL.\n* Patient who has voluntarily consented to the use of their data and signed a non-opposition form for the use of their biological and tumor samples.\n\nExclusion Criteria:\n\n* Metastatic patient (M1).\n* No curative treatment possible.\n* History of cancer (other than basal cell carcinoma) in the last 5 years.\n* Tumor size deemed insufficient according to the assessment of the ENT surgeon.\n* Patient refusal to allow the use of their biological and tumor samples for research.\n* Vulnerable persons are defined in articles L1121-5 to -8:\n\n  * Pregnant women, women in labor, and nursing mothers, individuals deprived of liberty by a judicial or administrative decision, individuals hospitalized without consent under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of article L. 1121-8,\n  * And individuals admitted to a health or social establishment for purposes other than research,\n  * Adults under legal protection or unable to express their non-opposition.",{"count":173,"type":20},250,"Metabolomics, thanks to advances in mass spectrometry, allows for the analysis of cellular metabolites to better understand biological processes. In oncology, it provides a global view of metabolic alterations in tumors and enables the classification of cancers based on various medical parameters using advanced statistical methods (machine learning). Its low cost and speed make it a promising approach in personalized medicine.\n\nCancers of the upper aerodigestive tract (UADT), the fifth most common cancer in France, are often diagnosed late, reducing survival chances (35-50% at five years). Identifying a specific metabolomic signature for these cancers could facilitate early detection, assess treatment response, and rapidly detect recurrences. Additionally, HPV-induced tumors may exhibit a distinct metabolic profile compared to those caused by tobacco and alcohol. Currently, no published studies have explored this topic for UADT cancers, highlighting the need for such research.\n\nThe aim of this study is to identify a metabolomic signature associated with the presence of UADT cancer at initial diagnosis and during post-therapeutic follow-up (three months after treatment completion). Hypothesis is that a specific metabolomic signature will be observed in the biological samples of patients diagnosed with UADT cancer, that the type of observed signature could be correlated with tumor site, stage, HPV status, and prognosis, and that the persistence or disappearance of this metabolomic signature three months after treatment may be associated with the risk of recurrence. The search for this potential metabolomic signature will be conducted using tumor biopsies, plasma, and urine samples at the initial diagnostic phase and plasma and urine samples at three and six months post-treatment follow-up.\n\nUltimately, the benefits of this study lie in improving early diagnosis, treatment (adjusting treatment based on the prognostic value of specific metabolomic signatures), and follow-up (early detection of recurrences, adapting monitoring to each patient's individual risk) of UADT cancers.\n\nAs the study is based on biological samples collected as part of standard patient care (with no additional biological tests or procedures performed specifically for research), no research-related risk is expected for the patient.\n\nThis is a prospective, single-center study involving patients with histologically confirmed, untreated squamous cell carcinoma of the UADT (oral cavity, oropharynx, larynx, and hypopharynx) who will receive curative treatment at the Antoine Lacassagne Center.\n\nThe search for a potential metabolomic signature will be conducted using biological and tumor samples collected as part of standard patient care, without requiring additional tests or procedures.\n\nThe primary objective of the study is to identify a metabolomic signature in patients with UADT cancer.\n\nThe secondary objectives of the study are:\n\n* To investigate the correlation between a metabolomic signature and tumor characteristics.\n* To examine the relationship between a metabolomic signature at three to six months post-treatment and oncological status at three to six months and one year post-treatment in patients with UADT cancer.",[176],"Upper AerodigestiveTract Cancer","2026-01-22",{"date":158,"type":37},{"date":180,"type":37},"2020-11-04",{"date":182,"type":20},"2027-05",{"name":43,"class":44},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":164},"100321629","phase-1-phase-i-trial-of-carbonic-anhydrase-inhibition-in-combination-with-radiochemotherapy-or-radioimmunotherapy-in-small-cell-lung-carcinoma-100321629","NCT03467360","Phase I Trial of CArbonic Anhydrase Inhibition in Combination With Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma","ICAR","Inclusion Criteria:\n\n* Age \\> or = 18 years,\n* Performance Status 0 to 2,\n* Patient with an histologically non-metastatic localized (or extensive SCLC sub-group) Small cell lung cancer,\n* Patient who must start radiotherapy treatment combined with chemotherapy with platinum and etoposide (localized SCLC sub-group) or Patient who received 4 cycles of chemoimmunotherapy with platinum salts, etoposide and immunotherapy (atezolizumab or durvalumab) as the first treatment (extensive SCLC sub-group) Note: The decision of the Multidisciplinary Consultation Team must be notified in the patient's medical file,\n* Evaluation lesion according to the criteria RECIST 1.1 and \u002F or according to the criteria PERCIST 1.0,\n* Women of childbearing potential must have a negative serum pregnancy test within 72 hours of the first administration of the study treatment,\n* If the patient is a woman of childbearing potential, she must be surgically sterile or agree to use two adequate methods of contraception throughout the duration of the study until 1 month after the last administration of the study treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year, Note: Abstinence is acceptable if it is the patient's usual and preferred form of contraception,\n* If the male patient has one or more female partners of childbearing age, he \u002F she must agree to use an adequate method of contraception, starting at the first administration of the study treatment up to 1 month after the last administration of the treatment. of the study, Note: Abstinence is acceptable if it is the patient's usual and preferred form of contraception,\n* Patient willing and able to provide written informed consent\u002Fassent for the trial,\n* Patient affiliated with a health insurance system.\n\nExclusion Criteria:\n\n* Patient with metastatic disease,\n* History of thoracic irradiation or near \u002F in the thoracic irradiation field,\n* Patient who refuses to participate in the study or unable to agree,\n* Contraindication to thoracic radiotherapy treatment: congestive heart failure unbalanced (ejection fraction \\\u003C30%, clinical signs), severe respiratory failure:\n\n  * COPD grade IV according to the GOLD classification,\n  * Some GOLD III COPD and any patient with a respiratory defect defined as: oxygen dependence and \u002F or FEV1 \\\u003C40% normal and \u002F or, DLCO \\\u003C40% predictive value and \u002F or vital capacity \\\u003C40% predictive value,\n* Contraindication to acetazolamide: hypersensitivity to acetazolamide, severe hepatic, renal or adrenal insufficiency, sulfonamide intolerance, history of renal colic, allergy to wheat other than celiac disease,\n* Patient currently receiving one or more treatments described in section 6.9 of the protocol,\n* History of cancer, with the exception of cancers in complete remission for more than 5 years, completely resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer,\n* People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside a state to express their consent, pregnant or breastfeeding women",{"count":192,"type":20},27,[194],"PHASE1","The investigators propose to study the carbonic anhydrase inhibition (acetazolamide) associated with concomitant radiochemotherapy or radioimmunotherapy in small cell lung cancer due to:\n\n1. The over-expression of carbonic anhydrases in this type of cancer,\n2. The Anti-tumor effect in preclinical acetazolamide in various tumor lines including neuroendocrine tumor lines,\n3. The observed synergy between irradiation and inhibition of carbonic anhydrases,\n4. Potential anti-tumor immune effect caused by decreased extracellular acidity.",[197],"Small Cell Lung Cancer",[199],"acetazolamide","2026-01-16",{"date":202,"type":37},"2026-01-20",{"date":204,"type":37},"2019-08-02",{"date":206,"type":20},"2027-04-27",{"name":43,"class":44},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":67},"100564327","phase-2-locally-advanced-nsclc-treated-with-radiochemotherapy-phase-2-study-on-the-value-of-a-stereotactic-boost-100564327","NCT06627738","Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost","Cybertaxcis II","Inclusion Criteria:\n\n1. Patients aged 18 years old or more\n2. ECOG 0 to 2\n3. Histologically proven non-small cell lung cancer\n4. Stage III non-metastatic tumor, not allowing for immediate surgery\n5. Volume(s) on the evaluation chest CT scan done at the end of conventional radiotherapy (between 34 \\& 46 Gy) meeting the following criteria:\n\n   * 1 to 3 target volumes of less than 5 cm in greatest diameter\n   * And allowing for the delivery of a CyberKnife boost to be carried out in compliance with the manufacturer requirements and with the doses delivered to the organs at risk (OAR\u002Ffractions) defined in appendix 2\n6. Patients who have received a \" Taxcis \" treatment consisting in 2 cycles of induction chemotherapy (platinium-based doublet) and then at least 40 Gy of irradiation in combination with at least 2 cycles of concomitant chemotherapy (platinium-based doublet)\n7. No contraindication to implantable venous devices (IVDs)\n8. Patient who has read the patient information note and signed the consent form\n9. If applicable, negative pregnancy test\\*\n10. Eligible for National Health Insurance in France\n11. Chest CT scan performed prior to Taxcis\n\nExclusion Criteria:\n\n1. Positive EGFR mutation\n2. Exercise-induced dyspnea associated with heart failure equal to or greater than stage III of the New York Heart Association (NYHA) classification, (appendix 3)\n3. Coronary syndrome or heart failure in the last three months\n4. Pulmonary function test contraindicating radiotherapy: PFT-FEV1 inferior to 1 L.\n5. After radio-chemotherapy, presence of any toxicity contraindicating Cyberknife irradiation\n6. Vulnerable populations and participants as defined in Articles 64 to 68 of Regulation (EU) 2017\u002F745 of the European Parliament and of the Council of 5 April 2017:\n\n   * Incapacitated participants who have not given or refused informed consent prior to the onset of their incapacity, who are not under the provisions of article 64 ;\n   * Pregnant or breast-feeding women who are not covered by the provisions of article 66 ;\n   * Adults under legal protection or unable to express their consent.",{"count":216,"type":20},42,[152],"This is a monocentric, non-randomized, open-label, superiority phase II clinical investigation evaluating the efficacy of additional Cyberknife irradiation after a doublet of Platinum Salts-based chemotherapy and concomitant radiotherapy in patients with locally advanced non-small cell lung carcinoma (NSCLC), with an interim analysis.",[220],"Carcinoma, Non-Small-Cell Lung","2025-12-30",{"date":223,"type":37},"2026-01-05",{"date":225,"type":37},"2025-06-10",{"date":227,"type":20},"2034-02",{"name":43,"class":44},{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":147,"minAge":17,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":67},"100546890","comparison-of-the-efficacy-of-cryotherapy-combined-with-compression-in-preventing-neuropathy-100546890","NCT06400849","Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing Neuropathy","Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing the Development of Paclitaxel-induced Peripheral Neuropathy in Non-metastatic Breast Cancer: A Prospective, Single-centre, Self-controlled Trial","ARIANE","Inclusion Criteria:\n\n* Patient age ≥ 18 years ;\n* Performance Status (PS): 0 to 2\n* Women with localised or locally advanced breast cancer of any histology\n* Indication for treatment with 3 to 4 cycles of paclitaxel (+\u002F- trastuzumab, pertuzumab, carboplatin or endoxan) as adjuvant or neoadjuvant therapy. The choice of the number of cycles will be at the investigator's discretion.\n* Symmetry of upper limb peripheral neuropathy grade ≤ 1 according to CTCAE version 5.0 at inclusion.\n* Presence of radial pulses in the upper limbs.\n* Presence of tibio-posterior and tibio-anterior ankle pulses or ankle systolic pressure index \\> 0.9.\n* Patient has read the information note and signed the informed consent form.\n* The patient is covered by social security.\n\nExclusion Criteria:\n\n* Patient age \\\u003C 18 years\n* Patients diagnosed with metastatic or bilateral breast cancer\n* Patients with metastatic disease of any location\n* Peripheral neuropathy grade ≥ 2 according to CTCAE version 5.0 of the upper or lower limbs\n* Patients with asymmetric upper limb peripheral neuropathy grade \\> 1 according to CTCAE version 5.0 at inclusion.\n\n  \\*In the case of asymmetry of the lower limbs of grade \\> 1 according to CTCAE version 5.0, the patient will not be considered a failure in selection but the corresponding secondary criteria will not be analysed.\n* Patients with underlying medical conditions that could potentially cause peripheral neuropathy (diabetes mellitus, chronic alcoholism, unilateral lymphoedema or postherpetic neuralgia), or any other reason based on the investigator's judgement.\n* Diagnosed Raynaud's syndrome\n* Obstructive arterial disease of the lower limbs\n* History of myocardial infarction\n* Patients already using compression foot socks\n* Vulnerable populations and participants defined in Articles 64 to 68 of Regulation (EU) 2017\u002F745 of the European Parliament and of the Council of 5 April 2017:\n\n  * Pregnant women\n  * Incapacitated participants who have not given their free and informed consent or refused to do so before the onset of their incapacity, who do not fall under the provisions of Article 64 ;\n  * Pregnant or breast-feeding women who are not covered by the provisions of article 66;\n  * Persons of full age who are the subject of a legal protection measure or who are unable to express their consent.","99 Years",{"count":239,"type":20},60,[97],"Breast cancer is the most frequently diagnosed cancer in the world. In France, 58,000 new cases were detected in 2018. Breast cancer is therefore the most common cancer in women. The 5-year survival rate for all stages combined is 88%. These excellent survival figures have been achieved thanks to improvements in treatment, including the advent of chemotherapy. The majority of patients will be cured of their cancer, so post-cancer quality of life is a major issue, hence the importance of trying to reduce long-term sequelae.\n\nTaxanes are one of the main cytotoxic anticancer agents used in the treatment of breast cancer. However, taxanes have a direct effect on the central and peripheral nervous systems and can induce chemotherapy-induced peripheral neuropathy (CIPN). The mechanisms of NPIC by taxanes are not fully understood. CINP is manifested by symptoms of paresthesia, numbness, burning, pain, altered temperature perception, myalgia, myopathy, fine motor difficulties, gait and balance disturbances, muscle weakness in the lower limbs and\u002For functional decline.\n\nNPIC occurs in 80 to 97% of patients treated with taxanes and is the main limiting toxicity during paclitaxel administration. NPIC often leads to postponement or reduction of dose, or even discontinuation of treatment. In addition, NPIC may last for several months or even years after the end of anti-cancer chemotherapy and represents the main long-term sequelae. This can promote and\u002For exacerbate symptoms of psychological distress (depressive symptoms and symptoms of anxiety) and lead to a reduction in quality of life (QoL). Prevention of NIPC is therefore a major issue in breast cancer treatment. According to the 2014 guidelines from the American Society of Clinical Oncology, prevention and treatment of IPN are inadequate with current weapons, and there is an urgent need to evaluate and find new methods of prevention. One of the challenges in the management of NIPC will be to reduce the pain induced without diminishing the anti-tumour effect of anti-cancer agents.\n\nIn recent years, the effectiveness of cryotherapy using a frozen glove and compression therapy using surgical gloves (SG) in preventing taxane-induced PINC has been reported. During chemotherapy, patients wore a frozen glove on one hand and two surgical gloves of the same size on the other hand continuously. Recent study explained how compression therapy and cryotherapy shared a similar mechanism of reducing drug exposure due to vasoconstriction during paclitaxel infusion. The low temperature associated with cryotherapy would reduce paclitaxel uptake and peripheral nerve damage, or mechanotransduction, and allow a reduction in NIPC.\n\nTo date, no study has investigated the efficacy of combining the two means of prevention. The current standard at the Centre Antoine Lacassagne is cryotherapy. The aim of this prospective, self-controlled trial is therefore to compare the efficacy of cryotherapy combined with compression prevention versus cryotherapy alone in preventing paclitaxel-induced peripheral neuropathy in patients undergoing adjuvant treatment for localised breast cancer.",[243],"Non-metastatic Breast Cancer",[245,246,247,248,249],"Non-metastatic breast cancer","Peripheral neuropathy","paclitaxel","cryotherapy","compression therapy","2025-12-17",{"date":252,"type":37},"2025-12-23",{"date":254,"type":37},"2024-04-04",{"date":256,"type":20},"2027-06-04",{"name":43,"class":44},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":267,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":67},"100576219","development-of-preclinical-models-derived-from-tumors-with-a-molecular-abnormality-of-interest-to-test-their-sensitivity-to-new-anti-tumor-therapies-100576219","NCT06782451","Development of Preclinical Models Derived From Tumors With a Molecular Abnormality of Interest to Test Their Sensitivity to New Anti-tumor Therapies.","DST","Inclusion Criteria:\n\n* Age 18 years or older.\n* Patient for whom at least one mutation deemed of interest by the investigator has been identified.\n* Patient with a malignant tumor at a locally advanced or metastatic stage, for whom a tissue tumor sample (via surgery, radiology, or endoscopy) is scheduled as part of their standard care.\n* Tumor volume deemed sufficient by the physician to ensure an adequate amount of material for analysis by the pathologist and the transfer of a part of the tumor sample to the Laboratory of Translational Research in Oncology for the study.\n* INR \\\u003C 1.5; Platelets \\> 50,000\u002FμL.\n* Patient who has been informed of the study and has signed the informed consent form.\n* Patient affiliated with a social security insurance.\n\nExclusion Criteria:\n\n* Patient with multiple primary malignant tumors.\n* Patient with a known HIV, Hepatitis C, or Hepatitis B infection.\n* Patient on:\n\n  * Clopidogrel (hydrogensulfate) or Prasugrel (hydrochloride) or Ticlopidine (hydrochloride) with no possibility of suspension for 5 days,\n  * Low molecular weight heparin with no possibility of dose suspension before the procedure,\n  * Fondaparinux with no possibility of suspension,\n  * Abciximab with no possibility of suspension for 24 hours and aPTT \\\u003C 50s and ACT \\\u003C 150s,\n  * Eptifibatide or Tirofiban Hydrochloride Monohydrate or Argatroban with no possibility of suspension 4 hours before the procedure,\n  * Bivalirudin with no possibility of suspension 2-3 hours if CrCL \\>50 mL\u002Fmin or 3-5 hours if CrCL \\\u003C50 mL\u002Fmin before the procedure,\n  * Dabigatran etexilate with no possibility of suspension 2-3 days if CrCL \\>50 mL\u002Fmin or 3-5 days if CrCL \\\u003C50 mL\u002Fmin before the procedure.\n* Patient considered vulnerable; vulnerable persons are defined in articles L1121-5 to L1121-8:\n\n  * Pregnant women, parturients, and breastfeeding mothers,\n  * Individuals deprived of their liberty by a judicial or administrative decision, individuals hospitalized without consent under articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, and individuals admitted to a healthcare or social facility for reasons other than research,\n  * Adults under legal protection or unable to express their consent.",{"count":266,"type":20},50,[97],"This study aims to collect tumor samples from patients carrying a mutation of interest to develop a cell culture technique for \"spheroids.\n\nThe goal is to use these spheroids to model responses to anticancer treatments. Various therapeutic molecules can be tested on these spheroids, enabling the evaluation of the potential of new molecules or the activity of existing ones specifically on the tumor (bearing the mutation of interest) from which the spheroid was developed.\n\nTumor samples will be collected as part of biopsies or surgeries conducted during routine patient care.",[270],"Neoplasm Malignant",[272,273],"Spheroids","Preclinic models","2025-09-24",{"date":276,"type":37},"2025-09-29",{"date":278,"type":37},"2025-05-02",{"date":280,"type":20},"2030-07-02",{"name":43,"class":44},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":67},"100562684","study-on-the-contribution-of-the-genetic-tumor-profile-obtained-by-circulating-tumor-dna-analysis-in-the-multidisciplinary-molecular-biology-meeting-of-eastern-paca-100562684","NCT06606366","Study on the Contribution of the Genetic Tumor Profile Obtained by Circulating Tumor DNA Analysis in the Multidisciplinary Molecular Biology Meeting of Eastern PACA","TARGET","Inclusion Criteria:\n\n* Over 18 years old.\n* Advanced-stage malignant solid tumor managed in a non-curative context.\n* Patient eligible for Multidisciplinary molecular biology meeting with available archived tumor material (frozen or FFPE block, less than 5 years old) or a biopsiable tumor lesion.\n* Performance status of 0 or 1.\n* Patient able to read, write, and understand the French language.\n* Patient has read the information sheet and signed the informed consent.\n* Patient has social security coverage.\n\nExclusion Criteria:\n\n* Previous or concurrent cancer diagnosed or treated within the last 5 years, except for in situ carcinoma of the cervix, basal cell or squamous cell carcinoma of the skin, and adequately treated in situ carcinoma of the bladder.\n* Severe or uncontrolled systemic disease.\n* Any condition which, in the investigator's judgment (geographical, social, or psychological factors, etc.), makes the patient unable to comply with study follow-up and procedures.\n* Patient considered a vulnerable person; vulnerable persons are defined in Articles L1121-5 to L1121-8:\n\n  * Pregnant women, women in labor, and breastfeeding mothers,\n  * Persons deprived of liberty by judicial or administrative decision, individuals hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8,\n  * Persons admitted to a healthcare or social institution for reasons other than research,\n  * Adults unable to give their consent.",{"count":290,"type":20},238,[97],"This study will evaluate the diagnostic performance of liquid biopsy for identifying molecular abnormalities among patients managed by the Multidisciplinary Molecular Biology Meeting. The gold standard considered in this study is the solid biopsy.",[270],[295],"Liquid biopsy","2025-04-10",{"date":298,"type":37},"2025-04-13",{"date":300,"type":37},"2025-03-03",{"date":302,"type":20},"2027-06-03",{"name":43,"class":44},{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":21,"phases":314,"briefSummary":315,"conditions":316,"keywords":319,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},"100327844","phase-2-stereotaxic-body-irradiation-of-oligometastase-in-sarcoma-stereosarc-100327844","NCT03548428","Stereotaxic Body Irradiation of Oligometastase in Sarcoma (Stereosarc)","Randomized Phase II, 2-arm Study of Immunomodulation with Atezolizumab Concomitant with High Dose Radiation (SBRT) Versus SBRT Alone in Patients with Oligometastatic Sarcomas","Stereosarc","Inclusion Criteria:\n\n* • STS (leiomyosarcomas uterine\u002Fextra-uterine, liposarcomas, undifferentiated sarcomas), any grade\n\n  * Progressive disease according to RECIST 1.1 criteria,\n  * Metastatic disease (1-5 synchronous macroscopic metastases by chest and abdominopelvic CT, maximal cumulated diameter 10 cm); any anatomic site\n  * First or second metastatic line\n  * Be ≥ 18 years of age on day of signing informed consent.\n  * Have a performance status of 0 or 1 on the ECOG Performance Scale.\n  * Have at least one lesion mesurable by RECIST 1.1 for irradiation with a size of \\\u003C 5 cm.\n  * Demonstrate adequate organ function: Absolute neutrophil count (ANC) ≥1,500 \u002FmcL; Platelets ≥100,000 \u002F mcL; Hemoglobin ≥9 g\u002FdL or ≥5.6 mmol\u002FL; Serum creatinine ≤1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥50 mL\u002Fmin for subject with creatinine levels \\> 1.5 X institutional ULN; Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases. All screening labs should be performed within 15 days of treatment initiation.\n  * Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n  * Surgical ablation (or other ablative methods such as thermal ablative methods) remains possible if needed before SBRT, at least 4 weeks before randomisation and provided that at least one lesion needs to be treated by SBRT.\n  * FFPE Tumor tissue collected before SBRT is available for immunohistochemistry (optional)\n  * Archival metastatic biopsy blocks (or slides) on paraffin embedded samples available. If no archival material is available, a fresh biopsy should be performed if possible.\n  * Be willing and able to provide written informed consent\u002Fassent for the trial.\n  * affiliated with a health insurance system.\n\nExclusion Criteria:\n\n* Is currently participating in, or has participated in, a study of an investigational agent or using an investigational device within 4 weeks prior to randomisation.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Has had a prior monoclonal antibody within 4 weeks prior to randomisation or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has had prior chemotherapy or targeted small molecule therapy within 4 weeks prior to randomisation or who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study). If subjects received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n* Have had previous radical radiation to any tumour site within 4 weeks prior to randomisation\n* Have had previous ablative treatment within 4 weeks prior to randomisation (radiofrequency, surgery)\n* Has a tumour within 5 mm of the spinal cord (owing to rare reported cases of flare-up after initiation of immunotherapy)\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.\n* Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study.\n* Has evidence of symptomatic interstitial lung disease or an active, non-infectious pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance-abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies).\n* Has known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA \\[qualitative\\] is detected).\n* Has received a live vaccine within 30 days prior to the first dose of trial treatment.\n* Has had major surgery or major blood transfusions (\\>3 packed cells) in the past 3 months.\n* Receives IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses)\n* Under-age patients\n* Patients unable to express their consent\n* Vulnerable persons as defined by article L1121-5 - 8:\n* Pregnant women, women in labor or breast-feeding mothers, persons deprived of their freedom by judicial or administrative decision, persons hospitalized without their consent by virtue of articles L. 3212-1 and L. 3213-1 and who are not subject to the provisions of article L. 1121-8\n* Persons admitted to a social or health facility for reasons other than research\n* Adults subject to a legal protection order or unable to give their consent",{"count":313,"type":20},103,[152],"Up to 50% of soft tissue sarcoma (STS) patients will develop metastases in the course of their disease. Cytotoxic therapy is a standard treatment in this setting but yields average tumor response rates of 25% at first line and ≤10% at later lines. It is also limited in the number of lines and courses by tolerance issues. Trials include poly\u002Foligometastases indistinctively and suggest that consolidation ablation is used in \\~20% of patients with residual oligometastases refractory to chemotherapy. Oligometastases represent a stage of disease between completely absent and widely metastatic, and which might be cured if the limited numbers of metastatic sites are eradicated. Ablative strategies to treat patients with oligometastases from sarcomas yield prolonged survival times and stereotactic body radiation therapy (SBRT) is associated with excellent tolerance. Surgery may be offered in selected metastatic cases. Alternatively and increasingly, SBRT yields high control rates at treated sites (≥ 80%). The so-called radioresistance of sarcomas is overcome by the high doses per fraction made possible owing to the high precision achieved with SBRT. SBRT is an accepted treatment strategy provided that tumor burden remains limited in the number and size of metastases. Systemic treatment can be combined with SBRT. SBRT may produce abscopal effects where tumors outside the irradiation area also demonstrate tumor shrinkage in some occurrences. SBRT produces systemic antitumoral immune response in certain conditions and enhances radiation-induced tumor cell death compared to conventional lower dose irradiation. Abscopal effects have been potentialized with SBRT\u002Fimmunotherapy in several tumor models. Sarcomas are a privileged target tumor given their high metastatic propensity.\n\nSeveral potent immunomodulators that skew the tumor immune microenvironment toward a proimmunity context are being investigated in STS either alone or in combination with chemotherapy or targeted therapy. The PD-1 receptor is present within the tumor microenvironment, and limits the activity of infiltrating cytotoxic T lymphocytes, thus blocking effective immune responses. The action of PD-1 is triggered upon binding to its ligands. PD-1 can stimulate the immunosuppressive function of regulatory T cells. Moreover, blockade of PD-1 can stimulate anti-tumor immune responses. Significant responses have been obtained in several sarcomas with acceptable tolerance. Preliminary clinical experience suggests that immunotherapy can be efficient in refractory leiomyosarcomas. Several drugs targeting the PD-1\u002FPD-L1\u002F2 axis are ongoing either as single agents or in combination with ipilimumab, kinase inhibitors, or chemotherapy in STS subtypes. Combination of radiotherapy with immunotherapy is included as a means of increasing tumor antigen release in metastatic STS. Immunomodulated SBRT is a particularly attractive strategy, given the potential of radiation to induce cytotoxicity in tumors and induce abscopal effects. A phase II radiation trial showed increased apoptosis-, intra-tumoral dendritic cells and accumulation of intratumoral T cells in STS with correlation with tumor-specific immune responses.\n\nWe here propose a randomized phase II study to prolong progression-free survival (PFS) with the combination of SBRT\u002Fimmunotherapy in oligometastatic STS patients.\n\nSBRT is well-tolerated with hardly any severe toxicity (fewer than 5% acute and late grade 3 toxicities). It is performed in an ambulatory setting in only a few treatment fractions. Associations between irradiation and immunomodulatory agents appear to be synergistic and show favorable tolerance profiles. Immunomodulatory agents have a more favorable toxicity profile than cytotoxic agents with about 65% overall acute toxicities. Immunotherapy selectively binds to PD-L1 and competitively blocks its interaction with PD-1.\n\nCompared with anti-PD-1 antibodies that target T-cells, immunotherapy targets tumor cells, and is therefore may induce fewer side effects, including a lower risk of autoimmune-related safety issues, as blockade of PD-L1 leaves the PD-L2 - PD-1 pathway intact to promote peripheral self-tolerance.\n\nStereotactic irradiation is associated with an excellent tolerance with rates of grade 3 or more toxicities below 5%.\n\nPreliminary data of toxicity with the association of stereotactic irradiation and immunotherapy show no cumulative toxicity in association with immunotherapy. However, their incidence and characteristics are no different from that observed with stereotactic irradiation alone. Moreover, intracranial metastases are exceptional in sarcomas.\n\nThe toxicity of the association for extracranial stereotactic irradiation does not seem to be increased either.",[317,318],"Sarcoma","Radiosurgery",[320,321,322],"Atezolizumab","Oligometastatic Sarcomas","stereotactic body radiation therapy","2025-02-18",{"date":325,"type":37},"2025-02-19",{"date":327,"type":37},"2020-06-04",{"date":329,"type":20},"2031-02-04",{"name":43,"class":44},17,{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":21,"phases":342,"briefSummary":343,"conditions":344,"keywords":349,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":67},"100518336","analysis-of-the-toxicity-and-efficacy-of-daily-1-vs-2-beam-proton-therapy-100518336","NCT06029218","Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy","Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy : Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy","P1V2","Inclusion Criteria:\n\n* Chordoma, chondrosarcoma of the skull base and spine, Ewing's sarcoma, and osteosarcoma meeting the criteria for treatment by proton therapy\n* Tumour requiring 2 beams\n* MRI less than one month old\n* PS 0-2.\n* Patient who has read the patient information note and signed the consent form.\n* Patient with healthcare insurance cover.\n* Age over 18 years.\n* For women of childbearing age, negative urine pregnancy test and effective contraception in place for the duration of treatment and for six months following the end of treatment.\n\nExclusion Criteria:\n\n* Persons deprived of their liberty or under guardianship.\n* Unable to undergo the medical follow-up of the clinical investigation for geographical, social or psychological reasons.\n* Patient eligible for symptom reduction surgery Vulnerable populations and participants defined in Articles 64 to 68 of Regulation (EU) 2017\u002F745 of the European Parliament and of the Council of 5 April 2017.",{"count":341,"type":20},106,[97],"Thanks to the intrinsic qualities of the proton beam, proton therapy will reduce adverse effects of irradiation. The Proteus®One is the latest generation of proton therapy equipment, enabling the Centre Antoine Lacassagne to expand its range of treatments by carrying out new proton therapy treatments. It has an innovative compact isocentric rotating head (Gantry) that allows the radiation beam to be directed at different angles around the patient. In some cases, two beams are used to treat tumours, and by convention, both beams are delivered during the same session. However, it is necessary to position the patient before each beam, which is time-consuming because 2 beams have to be positioned very precisely each day. The aim of this study is therefore to assess the toxicity of proton therapy delivered by a single daily beam compared with proton therapy delivered by two daily beams, which is the conventional technique.",[345,346,347,348],"Chordoma","Chondrosarcoma","Ewing Sarcoma","Osteosarcoma",[350],"protontherapy","2024-09-23",{"date":353,"type":37},"2024-09-25",{"date":355,"type":37},"2023-09-13",{"date":357,"type":20},"2031-10-01",{"name":43,"class":44},""]