[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centre Francois Baclesse\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":657},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,45,73,105,129,151,180,210,236,258,283,308,331,363,389,414,435,460,481,512,536,563,583,606,632],{"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":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100511721","phase-2-phase-ii-study-of-intensity-modulated-radiotherapy-in-dose-painting-for-sinus-carcinomas-after-endoscopic-surgery-100511721",false,"NCT05943119","Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery","SinocaRT","Inclusion Criteria:\n\n* Patients \\>18 years of age\n* Patient with a histologically confirmed malignant tumor of the sinuses, any histological type except melanoma, lymphoma, mesenchymal tumors (sarcoma)\n* Patient treated by endoscopic sinonasal surgery with histosurgical mapping within 2 months prior to radiotherapy\n* Indication for radiotherapy treatment (photontherapy or protontherapy), without neoadjuvant chemotherapy (concomitant chemotherapy is permitted)\n* Signature of informed consent prior to any specific study procedure\n* Subject affiliated to a social security system\n\nExclusion Criteria:\n\n* Patient with not operated in place tumor\n* Patient with distant metastases\n* Patient treated with neoadjuvant chemotherapy\n* Pregnant or breast-feeding woman or absence of contraception during genital activity\n* History of any other malignant disease in the last 3 years, except basal cell skin cancer, carcinoma in situ or superficial bladder tumor. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no sign of recurrence for at least 3 years.\n* Simultaneous participation in another therapeutic clinical trial\n* Patients deprived of their liberty, under guardianship, under curatorship, or subject to a legal protection measure, or unable to express their consent.\n* Patients unable to undergo trial monitoring for geographical, social or psychopathological reasons","ALL","18 Years",{"count":19,"type":20},52,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The patient is randomized to one of the following groups:\n\n* Experimental group: Radiotherapy in painting dose on histoscannographic mapping\n* Control group: standard pan-sinus radiotherapy",[26],"Tumor, Solid",[28,29,30,31],"IMRT","sinus","nasal","Mucosal toxicity","RECRUITING","2026-07-01",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":36},"2024-03-11",{"date":40,"type":20},"2029-03",{"name":42,"class":43},"Centre Francois Baclesse","OTHER",3,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100384819","phase-3-systematic-radioiodine-administration-versus-decision-of-radioiodine-treatment-guided-by-a-post-operative-work-up-100384819","NCT04290663","Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up","Multicentric Phase III Trial Comparing Two Strategies in Intermediate-risk Differentiated Thyroid Cancer Patients: Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up Based on Serum Tg Values and Diagnostic RAI Scintigraphy","INTERMEDIATE","Inclusion Criteria:\n\n* Subgroup of patients with differentiated thyroid cancer and intermediate-risk defined as follows according to TNM 2017:\n\n  * Papillary thyroid cancer (PTC) without aggressive subtype, follicular thyroid cancer (FTC) (with \\\u003C 4 foci of vascular invasion) or Hürthle cell carcinoma (HCC)\n  * T1b or T2 with minimal extra-thyroid extension into the perithyroidal soft tissues and\u002For pN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 10\n  * T1aN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 10\n* Patient treated by total thyroidectomy with macroscopically complete tumor resection (R0 or R1) ± neck dissection\n* Total thyroidectomy performed within 6 to 14 10 weeks before randomization\n* Patient with or without anti-thyroglobulin antibodies (TgAb)\n* No known distant metastases\n* Normal post-operative neck ultrasound (US) or if doubtful US, negative cytology and normal Tg value (\\\u003C10 ng\u002Fml) in FNA washout fluid\n* Post-operative LT4 treatment initiated at least 6 weeks before randomization\n* Performance Status 0 or 1\n* Patients aged 18 years or older\n* Signed informed consent form\n* Patient who agrees to be followed annually during 5 years\n* Patient affiliated to the French social security system\n\nExclusion Criteria:\n\n* • Patients with:\n\n  * medullary or anaplastic thyroid cancer\n  * or poorly differentiated carcinoma\n  * or well differentiated FTC with at least more than 4 foci of vascular invasion\n  * or PTC with aggressive variants (tall cell or columnar cell carcinoma, diffuse sclerosing papillary, hobnail variant)\n  * NIFTP (Noninvasive follicular thyroid neoplasm with papillary-like nuclear features)\n\n    • Low-risk or high-risk DTC patients according to ATA 2015, and intermediate-risk patients with extra-thyroid extension into the perithyroidal muscles (pT3b according to pTNM 2017), and\u002For pN1 with nodal largest dimension \\>10 mm or with extra-capsular invasion or more than 10 metastatic nodes. This excludes the following patients:\n  * All pT1a, pT3 or pT4\n  * pT1aN0\u002Fx with or without minimal extra-thyroid extension\n  * pT1bN0\u002Fx, pT2N0\u002FNx without minimal extra-thyroid extension\n  * pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension \\\u003C2mm\n  * pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension \\>10mm\n  * pT2N0\u002FNx without extra-thyroid extension\n  * pT2N1 without extra-thyroid extension and with nodal largest dimension \\\u003C2mm\n  * pT2N1 without extra-thyroid extension and with nodal largest dimension \\>10mm\n  * Surgery considered as macroscopically incomplete (R2)\n\n    * Patients who have undergone lobectomy only\n    * Post-operative neck US with metastatic lymph-nodes confirmed by cytology or by increased Tg (\\>10 ng\u002Fml) in FNA washout fluid\n    * Drugs affecting thyroid function including iodinated contrast agents in the 6 weeks prior to randomization. Amiodarone should have been stopped at least 1 year before randomization.\n    * Previous RAI treatment for thyroid cancer\n    * Pregnant or lactating women\n    * Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study\n    * Patient deprived of liberty or placed under the authority of a tutor\n    * History of malignancy in the past 3 years, except skin cancer excluding melanoma, carcinoma in situ of the cervix. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and not have shown signs of recurrence for at least 3 years",{"count":54,"type":20},368,[56],"PHASE3","This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy",[59,60],"Thyroid Cancer","Intermediate Risk",[62,63],"radioiodine","I131","2026-06-24",{"date":66,"type":36},"2026-06-25",{"date":68,"type":36},"2020-03-02",{"date":70,"type":20},"2033-02",{"name":42,"class":43},29,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100595105","phase-4-digital-monitoring-of-self-reported-symptoms-by-patients-treated-with-cabozantinib-plus-nivolumab-for-advanced-clear-cell-renal-carcinoma-100595105","NCT07028125","Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma","Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma: The CANIQOL Multicentre Study","CANIQOL","Inclusion Criteria:\n\n* Patient older than 18 years\n* Diagnosis of advanced\u002Fmetastatic Renal Cell Carcinoma (RCC) with a clear-cell component\n* No prior systemic treatment for RCC\n* Physician-initiated decision prior to study enrollment to treat with cabozantinib and nivolumab in combination, in first line for advanced\u002Fmetastatic RCC, according to approved local labels\n* Female subjects of childbearing potential must not be pregnant at screening and during treatment by Cabozantinib and Nivolumab. Effective methods of contraception must be used throughout the course of treatment and for at least 5 months after the end of treatment. Sexually active fertile subjects and their partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and 5 months after the last dose of study treatment, even if oral contraceptives are also used.\n* Subject affiliated to an appropriate social security system\n* Patient has signed informed consents obtained before any trial related activities and according to local guidelines\n\nExclusion Criteria:\n\n* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol\n* Current participation in another clinical study and\u002For in an investigational program with any intervention that could possibly interfere with the treatment and impact this study\n* Patient with history of allergy or hypersensitivity to components of the study drugs\n* Patient with contraindication to the study drugs\n* Pregnant or lactating woman\n* Patient unable to use digital tools\n* Patient deprived of liberty or placed under the authority of a tutor\n* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol",{"count":82,"type":20},83,[84],"PHASE4","The aim of the study is to evaluate the impact of digital monitoring of self-reported symptoms (PROs) on the adjustment of treatment management in patients treated with cabozantinib plus nivolumab for advanced clear cell renal cell carcinoma (RCC) in real life during the first 3 months of combined treatment",[87,88,89],"Renal Cell Carcinoma (Kidney Cancer)","Metastatic Renal Cell Carcinoma","Locally Advanced",[91,92,93,94,95],"kidney cancer","metastatic","cabozantinib","nivolumab","digital monitoring system","2026-06-04",{"date":98,"type":36},"2026-06-05",{"date":100,"type":36},"2025-10-01",{"date":102,"type":20},"2029-01",{"name":42,"class":43},16,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100382558","establishment-of-squamous-cell-organoids-of-the-head-and-neck-to-assess-their-response-to-innovative-therapies-100382558","NCT04261192","Establishment of Squamous Cell Organoids of the Head and Neck to Assess Their Response to Innovative Therapies","ORGAVADS","Inclusion Criteria:\n\n* Patient over 18 years of age;\n* Patient with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, classified T3Nx or T4Nx or T2N +, not previously treated;\n* Patient to be treated by surgery;\n* Patient affiliated to a social security scheme;\n* No opposition to participate in the study\n\nExclusion Criteria:\n\n* Pregnant woman ;\n* Persons deprived of their liberty or under guardianship (including curatorship);\n* History of malignant pathology preceding inclusion (apart from basal cell carcinomas of the skin and carcinomas in situ of the cervix treated surgically) or concomitant at inclusion (synchronous tumor)",{"count":113,"type":20},120,"OBSERVATIONAL","The emergence of tumor organoid cultures in recent years has made it possible to widen the repertoire of available preclinical tumor models and to bridge the gap between cell lines and tumors of xenografted patients in mice (PDXs).These organoids have the advantages of being able to be amplified fairly quickly after resection of the tumor, of having unlimited proliferation potential, a high rate of establishment success, and the possibility of being transfected and cryopreserved. These characteristics therefore allow them to summarize the clinical spectra of cancers, but also to be models for studying tumor progression as has been done with organoids for colorectal cancer. They are also very close morphologically and genetically to the tumor from which they derive.Finally, clinical trials are underway to determine whether the organoids of mammary, pulmonary and colorectal cancers can predict the response to patients' treatments and guide the therapeutic decision.It would therefore be possible to test multiple treatments on different samples. This would allow screening of a panel of treatments on a given tumor type but also to test a treatment ex vivo before administering it to the patient in vivo. This prospect is very interesting in particular in the tumors of the VADS where more than two thirds of the operated patients will benefit from a complementary treatment by radiotherapy and \u002F or chemotherapy whose consequences can be important. Despite this adjuvant management, up to 30% of patients will relapse, highlighting a variable tumor chemosensitivity. This screening could make it possible to refine the choice of treatments adapted to each patient and thus limit the undesirable effects.The feasibility of establishing head and neck squamous cell organoid lines seems encouraging, with organoids derived from squamous cell carcinoma of the oral cavity and oropharynx having been recently established.",[117],"Head and Neck Cancer",[119],"Organoid","2026-05-11",{"date":122,"type":36},"2026-05-12",{"date":124,"type":36},"2020-07-03",{"date":126,"type":20},"2032-02",{"name":42,"class":43},2,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":136,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"100470320","establishment-of-an-ex-vivo-tumor-collection-of-triple-negative-breast-cancers-in-order-to-validate-the-interest-of-innovative-therapies-and-the-search-for-predictive-biomarkers-of-response-to-treatment-100470320","NCT05404321","Establishment of an ex Vivo Tumor Collection of Triple-negative Breast Cancers in Order to Validate the Interest of Innovative Therapies and the Search for Predictive Biomarkers of Response to Treatment","TRIPLEX","Inclusion Criteria:\n\n* Patient over 18 years of age\n* Patient with early stage (I-III) triple negative breast cancer who needs to have clips placed before neoadjuvant chemotherapy\n* Patient affiliated to a social security system\n* Proficiency in French language,\n* Patient having signed the consent to participate in the study.\n\nExclusion Criteria:\n\n* Pregnant women\n* Persons deprived of liberty or under guardianship (including curatorship)\n* History of any other clinically active malignancy in the last 5 years prior to inclusion","FEMALE",{"count":138,"type":20},163,"Initially described in 2009 on LGR5 positive stem cells from intestine, organoids correspond to a 3D cell culture that preserves the organization and part of the initial function of the organ from which the cells were derived. They use the proliferation and differentiation properties of stem cells cultured in a three-dimensional matrix.\n\nThese principles have been adapted to many human organs, including the breast. These culture conditions have thus allowed the establishment of cancer organoid lines that have the advantages of rapid amplification, a high rate of establishment success and unlimited proliferation potential. They are transfectable and cryopreservable. They are very close morphologically and genetically to the tumor from which they derive. Very recently, the in vivo response of orthotopic xenograft models of breast cancer organoids has been correlated to the in vitro response of these same organoids. In addition, the in vitro response of various of these models to PARP inhibitors was linked to the presence of the BRCA1\u002F2 mutant signature, highlighting the potential of these models to predict patient response to these treatments.\n\nFurthermore, one study demonstrated the value of using organoids derived from metastatic gastrointestinal tumors to predict patient response to cancer treatments (100% sensitivity, 93% specificity, 88% positive predictive value, and 100% negative predictive value.",[141,119],"Triple Negative Breast Cancer","2026-03-17",{"date":144,"type":36},"2026-03-19",{"date":146,"type":36},"2023-01-09",{"date":148,"type":20},"2028-12",{"name":42,"class":43},1,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":163,"conditions":164,"keywords":168,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":150},"100589853","impact-of-adapted-aesthetic-onco-in-patients-with-upper-aerodigestive-tract-cancer-during-their-management-100589853","NCT06959810","Impact of Adapted Aesthetic Onco in Patients With Upper Aerodigestive Tract Cancer During Their Management","Impact of Adapted Aesthetic Onco in Patients With Cancer of the Upper Aero-digestive Tract During Their Management [ŒUVRE (Adapted Aesthetic Onco Aero-digestive Tract)]","OEUVRE","Inclusion Criteria:\n\n* Patient aged 18 or over\n* Neoplastic location: oropharynx, oral cavity, hypopharynx, larynx, nasal cavity, salivary glands, cavum, sinus.\n* Patient due to start oncological treatment (recurrence authorized)\n* Patient fluent in French.\n* Affiliation with a social security scheme\n* Signature of informed consent prior to any specific procedure linked to the study\n* Treatment with curative intent\n\nExclusion Criteria:\n\n* Breast-feeding or pregnant patient\n* Any associated medical or psychological condition that could compromise the patient's ability to participate in the study\n* Patient deprived of liberty, under guardianship, or subject to a legal protection measure or unable to express their consent.\n* Patient unable to undergo trial follow-up for geographical, social or psychopathological reasons.",{"count":160,"type":20},55,[162],"NA","Treatment for cancers of the pharyngolarynx is mutilating, with major consequences for patients' lives in terms of physical and functional after-effects. The psycho-social consequences are also significant, notably the metamorphosis of identity linked to the disease and its treatment, which alters the patient's self-image.\n\nInitial feedback from patients who have been able to benefit from adapted oncoesthetics (OEA) is overwhelmingly positive.\n\nThis study will assess the feasibility of oncoesthetics and describe any obstacles.",[165,166,167],"Oncology","Aerodigestive Tract Cancer","Suportive Care",[169,170,171],"Oncology (Organ: Upper Aero Digestive Tract)","Supportive Oncology","Organization of care","2026-03-11",{"date":174,"type":36},"2026-03-12",{"date":176,"type":36},"2025-10-24",{"date":178,"type":20},"2028-09-15",{"name":42,"class":43},{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":191,"conditions":192,"keywords":197,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":5},"100577486","phase-3-flap-sparing-in-postoperative-radiotherapy-of-oral-cavity-cancers-100577486","NCT06798922","Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers","Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers: a De-escalation Randomized Phase III Trial","OPTIFLAP","Inclusion Criteria:\n\n* Patient aged 18 years or older\n* Performance Status 0-2\n* Patient with oral cavity cancer (soft tissue or soft tissue-bone flap), treated by reconstructive surgery with a flap. Oropharynx cancer whose flap extends significantly into the oral cavity may be included in the study\n* Quality of resection with margins \\> 1 mm\n* Patient candidate to post-operative radiotherapy (Intensity-Modulated Radiation Therapy (IMRT) or proton therapy)\n* Concomitant chemotherapy is allowed (stratification parameter)\n* Patient must have signed a written informed consent form prior to any trial specific procedures\n* Patient affiliated to the social security system\n\nExclusion Criteria:\n\n* Local flap (small size limiting IMRT modulation potential)\n* History of radiotherapy of head and neck area\n* Metastatic disease\n* History of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)\n* Simultaneous participation in another clinical study may compromise the conduct of this study.\n* Pregnant or lactating women\n* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol\n* Patient deprived of freedom or under guardianship",{"count":189,"type":20},348,[56],"Patients with oral cavity cancer treated by reconstructive surgery with a flap.\n\nPatients will be treated in the study for :\n\n* Experimental arm: Post-operative radiotherapy with flap sparing\n* Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT)",[193,194,195,196],"Oral Cavity Carcinoma","Flap","Radiotherapy, Adjuvant","Reconstruction Surgery",[198,199,200,201,28],"protontherapy","flap","oral cavity carnicoma","radiotherapy","2026-03-02",{"date":204,"type":36},"2026-03-03",{"date":206,"type":36},"2025-03-01",{"date":208,"type":20},"2034-03-01",{"name":42,"class":43},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":224,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":235},"100447154","stereotactic-radiotherapy-in-oligometastatic-brain-disease-a-randomised-phase-iii-study-comparing-hypofractionated-stereotactic-radiation-therapy-310-gy-to-the-historical-single-dose-radiosurgery-120-to-25-gy-with-medico-economic-evaluation-100447154","NCT05102747","Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation.","OligoBM-01","Inclusion Criteria:\n\n* Patients aged ≥ 18 years\n* WHO performance status 0 or 1;\n* Patient eligible for SRT after a multidisciplinary committee decision; Patient with BMs from radioresistant cancer (renal cell carcinoma, sarcoma, melanoma) is eligible\n* Patient having up to 5 BM of solid tumours with an histologically proven diagnoses; patients who have had a metastasectomy and having 1 to 4 BM lesions is eligible (ANOCEF recommendations); post-operative cavity must be treated by radiosurgery according to local procedures with respect of non-inclusion criteria\\* (cavity will not be analyzed for efficacy)\n* Presence of at least one and no more than 5 target lesions for SRT, measuring between 10 and 25 mm. In the event of synchronous BM, lesions measuring less than 10mm or more than 25mm (1 to 4 lesions) will be treated at the discretion of the investigator\n* Max cumulative GTV of 30cm3\n* Normal complete blood count (CBC)\n* Absence of bleeding BM or meningeal carcinomatosis;\n* Symptomatic BM are allowed\n* DS-GPA score:\n\n  * Renal cancer: DS-GPA 2,5 or more\n  * Breast cancer: DS-GPA 2,5 or more\n  * Melanoma: DS-GPA 1.5 or more\n  * Gastro-instestinal (GI) cancer: DSGPA 3 or more\n  * Adenocarcinoma lung cancer: DS-GPA 2 or more (DS-GPAmol)\n  * Squamous lung cancer : DS-GPA 2,5 or more (DS-GPAmol)\n  * For cancers where the DS-GPA score is not applicable, the patient is eligible if eligibility criteria are met\n* Patient with no concomitant systemic treatment; in case of ongoing systemic treatment, wash out period of 3-7 days before and after SRT, depending of drug and at the discretion of investigator;\n* Patient sufficiently cooperating to perform the treatment with the use of a thermoformed mask;\n* Patient whose neuropsychological abilities allow to follow the requirements of the protocol;\n* Female with childbearing potential must use adequate contraception\n* Signed informed consent formOligoBM-01 Trial - ID-RCB number: 2021-A01622-39 - version 3.1 dated from 2023-06-22 Page 9 of 51\n* Patients affiliated to the social security system\n\nExclusion Criteria:\n\n* Patients with current or past history small cell lung cancer, germ-cell tumours, lymphoma, leukemia and multiple myeloma within the last 5 years;\n* Patients with metastases in the brain stem, or within 1 cm of the optic apparatus;\n* Patients with an associated neurodegenerative disease;\n* Any symptoms not attributable to BM or cancer disease requiring long term corticosteroid use (regardless of dose);\n* Contraindication to perform the brain MRI or gadolinium or iodinated contrast;\n* Known hypersensitivity to the contrast product or to any their excipients\n* Patients with previous brain stereotactic irradiation\n* Whole brain irradiation history;\n* Haemorrhagic metastasis;\n* Ongoing anti angiogenic treatment (treatment should be held 3-7 days before irradiation and re-initiated 3-7 days after irradiation for patient to be eligible);\n* Patients with too close brain lesions for whom a treatment plan on one target metastasis delivers a dose \\> 5 Gy on other concomitant metastasis ;\n* Patient deprived of liberty or under guardianship;\n* Known pregnancy or breastfeeding\n* Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study;\n* Participation in a therapeutic trial for less than 30 days.\n* Patient deprived of freedom or under guardianship",{"count":218,"type":20},504,[162],"Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of \"oligometastatic\" cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible.\n\nStereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature.\n\nHSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation.\n\nCommon adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment.\n\nTo investigators knowledge, SRS and HSRT have not been prospectively compared.",[222,223],"Brain Metastasis","Oligoprogression",[225,226],"Stereotactic radiosurgery","Fractionated stereotactic radiotherapy","2026-01-26",{"date":229,"type":36},"2026-01-27",{"date":231,"type":36},"2023-01-12",{"date":233,"type":20},"2031-01",{"name":42,"class":43},15,{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":21,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},"100385510","phase-2-a-phase-ii-study-assessing-stereotactic-radiotherapy-in-therapeutic-strategy-of-oligoprogressive-renal-cell-carcinoma-metastases-100385510","NCT04299646","A Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases","GETUG-StORM-01","Inclusion Criteria:\n\n* Clear cell renal cancer histologically proved (association with other histologic component are permitted)\n* Patients of good or intermediate prognostic, according to Heng criteria\n* Extracerebral metastatic disease documented with imagery\n* Patients treated in first or second line systemic therapy\n* Systemic treatment may be targeted therapies (tyrosine kinase inhibitors or mammalian target of rapamycin inhibitors) and\u002For immunotherapy according to French applicable standards; patients treated in a clinical trial are also eligible if allowed by trial sponsor\n* Oligoprogressive disease documented with imagery, defined as the emergence or progression of 1 to 3 metastases and progression localized in up to 2 organs\n* Oligoprogressive disease confirmed with 2 CT scans performed 2 months apart\n* At least one measurable progressing metastasis according to R.E.C.I.S.T. criteria v1.1\n* All oligoprogressive target lesions measuring ≤ 4 cm\n* Good general condition (WHO performance status ≤ 2)\n* All progressive lesions have to be accessible to SRT, performed concurrently or sequentially\n* No contraindication to systemic therapy and stereotactic radiation therapy\n* Patients aged 18 years or older\n* Signed informed consent form\n* Patients affiliated to the social security system\n\nExclusion Criteria:\n\n* More than 3 progressive metastases\n* Non measurable disease according R.E.C.I.S.T. criteria\n* Patients who received 3 or more lines of systemic therapy\n* Inability to treat all progressive metastatic sites with SRT\n* Previous radiation therapy performed in ≥ 1 target lesion\n* At least 1 oligoprogressive target lesion measuring \\> 4 cm\n* Presence of brain metastases\n* Presence of ultra-central pulmonary metastasis\n* Progressing metastasis in a long bone\n* At least 1 progressive metastasis requiring surgical treatment\n* Current or past history of second neoplasm diagnosed within the last 5 years\n* Pregnancy or breast feeding or inadequate contraceptive measures\n* Patients who cannot be adequately followed up\n* Patient deprived of freedom or under guardianship",{"count":244,"type":20},77,[23],"Every year, 12500 primary renal cell carcinoma (RCC) are diagnosed in France. Metastases occur in half of RCC patients.\n\nManagement of metastatic RCC is based on systemic treatments (targeted therapies\u002Fimmunotherapy). However, resistance to systemic treatment is frequent. In case of progression, usual therapeutic attitude is initiating another systemic therapy.\n\nBecause of the emergence of resistant tumor clonal cells, some patients progress only on few sites while the rest of tumor burden is controlled. In this setting named oligoprogressive disease \\[isolated progression of \\\u003C3-5 metastase(s)\\], ablative treatments of these evolving metastatic sites could allow a disease control and a reduced risk of new metastases occurrence by tumor-cell reembolization. Such strategy is challenging to prolong ongoing systemic treatment and delay further lines.\n\nAlthough RCC was considered radioresistant and radiotherapy with conventional fractionation was mainly used for palliation of symptoms, stereotactic radiotherapy (SRT), by delivering high dose in one or few fractions, allows local control for about 90% of RCC metastases through various radiobiological pathways. Furthermore, some data suggest that high-dose focal irradiation of RCC could induce a systemic antitumor response mediated by immunologic effectors(1). This phenomenon (\"abscopal effect\") could be enhanced in patients under immunotherapy, including anti-PD1.\n\nSeveral retrospective studies and one non-randomized phase-II study highly suggest the interest of SRT as focal ablative treatment in RCC oligometastases with excellent local control rates and low toxicity(2,3).\n\nFurthermore, the multicentric retrospective study the sponsor recently conducted within the GETUG group among 101 metastatic RCC patients with oligoprogression under systemic therapy highlighted that SRT on progressive sites provided a median of 8.6-month progression-free survival and allowed to continue current systemic line for 10.5 months.\n\nHowever, to date, there are no prospective data assessing the interest of SRT for management of oligoprogressive metastatic RCC.\n\nThe sponsor aim to prospectively evaluate the interest of SRT as a therapeutic strategy for local control of oligoprogressive metastatic RCC under ongoing systemic treatment, and consequently delay subsequent systemic treatment.",[88,248],"Radiotherapy","2026-01-12",{"date":251,"type":36},"2026-01-13",{"date":253,"type":36},"2020-07-01",{"date":255,"type":20},"2029-08",{"name":42,"class":43},30,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":265,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":273,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":128},"100531598","phase-2-efficacy-of-adapted-physical-activity-on-a-walking-platform-in-elderly-patients-hospitalized-for-cancer-surgery-100531598","NCT06201884","Efficacy of Adapted Physical Activity on a Walking Platform in Elderly Patients HOspitalized for Cancer Surgery","APPAHOCA-2","Inclusion Criteria:\n\n* Men or women aged 65 or over\n* Candidate for scheduled major oncological surgery and\u002For surgery with high morbidity\n* Patient able to walk for 10 minutes on the walking platform at the time of the test\n* Patient affiliated to a social security system\n* Signature of informed consent prior to any specific study-related procedure\n\nExclusion Criteria:\n\n* Patient with severe undernutrition (BMI\\\u003C18, and\u002For weight loss \\>15% in 6 months or \\>10% in 1 month)\n* Emergency surgery\n* Physical contraindications preventing use of the platform\n* Simultaneous participation in another clinical study that could compromise the conduct of this study\n* Patients deprived of their liberty, under guardianship or subject to a legal protection measure, or unable to express their consent.\n* Patient unable to undergo trial follow-up for geographical, social or psychopathological reasons.","65 Years",{"count":267,"type":20},60,[23],"The aim of this study was to evaluate the efficacy of daily use of a walking platform to improve recovery of preoperative walking speed at hospital discharge following oncological surgery in patients aged 65 or older.",[165,271,272],"Elderly Patients","Surgery",[274,275],"Adapted physical activity","walking platform","2026-01-08",{"date":249,"type":36},{"date":279,"type":36},"2024-03-15",{"date":281,"type":20},"2027-12",{"name":42,"class":43},{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":136,"minAge":17,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":21,"phases":292,"briefSummary":293,"conditions":294,"keywords":297,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":307},"100558629","impact-of-a-multidisciplinary-assessment-in-day-hospitalization-versus-standard-care-on-the-deployment-of-supportive-oncology-care-recommended-by-the-personalized-post-cancer-plan-in-patients-at-the-end-of-initial-treatment-for-gynecological-ovarian-and-endometrial-cancer-endometrial-cancer-100558629","NCT06553612","Impact of a Multidisciplinary Assessment in Day Hospitalization Versus Standard Care on the Deployment of Supportive Oncology Care Recommended by the Personalized Post-cancer Plan in Patients at the End of Initial Treatment for Gynecological Ovarian and Endometrial Cancer Endometrial Cancer","AFTERGYN2","Inclusion Criteria:\n\n* Patient \\> 18 years\n* Patients in remission from first-line treatment of endometrial or ovarian\u002Ftumor\u002Fperitoneal cancer.\n* Patient who has completed her initial treatment; patients on maintenance therapy are eligible.\n* Fluency in French\n* Patient with access to a telephone line\n* Patient affiliated to a social security scheme\n* Signature of informed consent prior to any specific study procedure\n\nExclusion Criteria:\n\n* Any associated medical or psychiatric condition that could compromise the patient's ability to participate in the study\n* Patient with locoregional or metastatic recurrence\n* Patient deprived of liberty, under guardianship or curatorship\n* Simultaneous participation in a therapeutic clinical trial",{"count":291,"type":20},268,[162],"This project proposes a structuring of supportive oncology care for the recovery phase after gynecological cancer (ovarian\u002Ftrope\u002Fperitoneum or endometrium). Patients will be divided into three groups based on the identification of oncological support care needs. Patients with supportive oncology care needs will be randomized into two groups: the experimental group, receiving a personalized post-cancer plan with a multidisciplinary assessment of supportive oncology care needs in a day hospital and coordinated follow-up by the referring study nurse, and the control group, receiving a personalized post-cancer plan without a day hospital. Randomization will be stratified according to tumor location (ovary vs. endometrium), use of supportive oncology care during treatment, and treatment center. Patients with no need for supportive oncology care will be followed in an observational cohort. The main objective is to identify and manage the supportive oncology care needs of patients in remission from endometrial or ovarian cancer to improve their quality of life and post-treatment follow-up. A medico-economic analysis will be performed.",[295,296],"Gynecologic Cancer","Remission",[298,299],"supportive oncology care","personalized post-cancer plan","2026-01-07",{"date":276,"type":36},{"date":303,"type":36},"2024-06-07",{"date":305,"type":20},"2028-06-07",{"name":42,"class":43},13,{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":150},"100563181","development-of-tumor-organoids-from-undifferentiated-primary-carcinomas-to-guide-therapeutic-decisions-100563181","NCT06612827","Development of Tumor Organoids From Undifferentiated Primary Carcinomas to Guide Therapeutic Decisions","OCAPI","Inclusion Criteria:\n\n* Patient with undifferentiated primary carcinoma (UPC) with histological and immunohistochemical evidence, validated in a local and\u002For national UPC multidisciplinary consultation\n* Patient with indication for systemic 1st-line treatment at the time of inclusion. Treatment may already have begun at the time of inclusion, but within the limit of 2 treatment cycles administered.\n* Patient with life expectancy greater than 3 months\n* Patient of legal age\n* Patient affiliated to a social security scheme\n* Signature of informed consent prior to any specific study procedure\n\nExclusion Criteria:\n\n* Persons deprived of their liberty or under guardianship (including curatorship)\n* Pregnant or breast-feeding patient",{"count":316,"type":20},20,"The study is based on the constitution of a collection of tumor and blood samples for the development of tumoroid for functional tests to predict clinical response to treatment.",[319],"Undifferentiated Carcinoma",[321,322],"tumoroid","organoid","2025-12-23",{"date":325,"type":36},"2025-12-24",{"date":327,"type":36},"2025-03-05",{"date":329,"type":20},"2032-12-15",{"name":42,"class":43},{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":136,"minAge":17,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":21,"phases":341,"briefSummary":342,"conditions":343,"keywords":347,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":362},"100578889","phase-3-benefit-of-transcutaneous-auricular-vagus-nerve-stimulation-in-improving-quality-of-life-in-first-line-treatment-of-ovarian-cancer-100578889","NCT06817161","Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:","Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer: the ESTANVO Randomized Trial","ESTANVO","Inclusion Criteria:\n\n* Patient ≥ 18 years old\n* ECOG 0-2\n* Histologically proven epithelial ovarian carcinoma\n* FIGO stage ≥ IIB\n* Patient candidate for first line chemotherapy treatment (alone, neoadjuvant or adjuvant)\n* Patient affiliated to an appropriate social security system\n* Patient who has signed informed consent obtained before any trial related activities\n\nExclusion Criteria:\n\n* Patient with an active implantable medical device or any other implanted electronic or electrical device (pacemaker, defibrillator, etc.)\n* Dermatological problems in the area where stimulation electrodes are applied\n* Recent history (\\\u003C2 years) of epileptic seizures\n* Proven severe cardiovascular disease (such as known FEV \\\u003C40%, severe valvulpathy…) or HRV analysis not possible (such as uncontrolled atrial fibrillation)\n* Serious ear pathology\n* Documented vegetative neuropathy\n* Unusual morphology of the left ear which does not allow the use of the device\n* Patient with a cochlear implant near to the stimulation site\n* Impaired cognitive abilities\n* Concurrent other malignancy (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)\n* Pregnant or breastfeeding woman\n* Simultaneous participation in another clinical study that may compromise the conduct of this study.\n* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol\n* Patient deprived of liberty or placed under the authority of a tutor",{"count":340,"type":20},116,[56],"Impact of stimulation of parasympathetic activity by transcutaneous auricular vagus nerve stimulation (taVNS) on quality of life (QoL) relating to digestive symptoms in patients undergoing first-line treatment for ovarian cancer, as compared to shame taVNS",[344,345,346],"Ovarian Carcinoma","First Line Chemotherapy","Digestive System Disorders",[348,349,350,351,352,353],"ovarian carinoma","parasympathetic","vagus nerve","transcutaneous auricular stimulation","quality of life","digestive symptoms","2025-10-03",{"date":356,"type":36},"2025-10-07",{"date":358,"type":36},"2025-04-30",{"date":360,"type":20},"2028-09-30",{"name":42,"class":43},4,{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":371,"enrollmentInfo":372,"targetDuration":4,"studyType":21,"phases":374,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":307},"100508049","long-term-cognitive-and-functional-impact-of-proton-therapy-or-modern-fractionated-radiotherapy-in-cavernous-sinus-meningioma-an-open-label-randomized-11-phase-iii-study-100508049","NCT05895344","Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma: An Open-label Randomized 1:1 Phase III Study","Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma","COG-PROTON-01","Inclusion Criteria:\n\n* Cavernous sinus meningioma for which clinical target volume is larger than 3 centimeters\n* Anterior skull base meningioma, invading by contiguity the cavernous sinus can be included\n* Histologic proven Grade I meningioma\n* Meningioma for which biopsy is not safely achievable and for which growing and imaging criteria are in favour of grade I meningioma can be included\n* Age \\>18 years and ≤70 years\n* Indication of irradiation validated by a pluridisciplinary meeting\n* Adjuvant or exclusive irradiation is allowed.\n* Use of conventional fractionation: 1.8Gy (RBE)\u002Ffraction\n* Signed informed consent form\n* WHO Performance status equal to 0 or 1\n* Patient affiliated to the French social health insurance\n* MoCA score ≥ cut-off of GRECOGVASC normative data (Roussel, 2016, cf annexe 1)\n* Patient whose neuropsychological abilities allow to follow the requirements of the protocol\n\nExclusion Criteria:\n\n* Patient with mutation in a known predisposition gene (NF-2, SMARCE-1…)\n* Cerebrovascular pathology, presence of other tumors of the nervous system, congenital malformations of the nervous system, multiple sclerosis, Parkinson's disease and other dementias, organic psychosis (other than dementia), schizophrenia, and neurodegenerative disease\n* Radiosurgery, hypofractionated regimen\n* Other localization than cavernous sinus\n* Histologic proven Grade II or III meningioma\n* Patient with unadjusted antiepileptic drug\n* Contraindication to MRI\n* Patient with a history of brain irradiation\n* Patient with a history of cancer in the last five years (excluding skin baso-cellular carcinoma)\n* Pregnant\u002Fbreastfeeding woman\n* Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study\n* Participation in a therapeutic trial for less than 30 days\n* Patient deprived of freedom or under guardianship","70 Years",{"count":373,"type":20},160,[162],"Cavernous sinus meningiomas are close to optic nerve, pituitary gland, cranial nerve, and hippocampi.\n\nThe doses delivered to these structures are crucial and radiotherapy of cavernous sinus meningiomas exposes patients to late secondary effects (pituitary deficit, nerve palsy, cognitive impairment…). In 2012, Gondi reported that a dose given to 40% of the bilateral hippocampi greater than 7.3 Gy is associated with long-term impairment in list-learning delayed recall after FSRT for benign or low-grade adult brain tumors.\n\nThere is no published or recruiting prospective study evaluating the impact of proton-therapy or conventional irradiation on neurocognitive function for meningioma patients. Notably, long-term cognitive or ocular impact of these modern irradiation schemes remains poorly known. Yet, these patients had a long life-expectancy, and are at risk of developing long-term sequelae. Thus, according to its ballistic advantage, an improvement of patient functional outcomes and a reduction of neurocognitive long-term toxicity are expected if tissue sparing proton-therapy is used.\n\nIn this context, a randomized prospective study, evaluating long-term toxicity of these two irradiation modalities (Proton Therapy (PRT) and photon radiotherapy (XRT)) seems crucial to further assess proton-therapy indication for these patients.\n\nAlthough literature reports excellent outcomes for intracranial meningioma patients treated by proton-therapy, none of the eight retrospective studies found in the literature used an accurate and full evaluation of long-term toxicity",[377,378,379,380],"Cavernous Sinus Meningioma","Proton-therapy","Photon Radiotherapy","Cognitive Impairment","2025-09-24",{"date":383,"type":36},"2025-09-29",{"date":385,"type":36},"2024-02-26",{"date":387,"type":20},"2032-08",{"name":42,"class":43},{"id":390,"slug":391,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":396,"sex":136,"minAge":397,"maxAge":265,"enrollmentInfo":398,"targetDuration":4,"studyType":21,"phases":400,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":128},"100471091","impact-of-sleep-disturbance-on-cognition-and-quality-of-life-in-breast-cancer-100471091","NCT05414357","Impact of Sleep Disturbance on Cognition and Quality of Life in Breast Cancer","ICANSLEEP","Inclusion Criteria:\n\n* Patients aged 39 to 69 years\n* Patient with operated localized breast cancer who may or may not be starting adjuvant chemotherapy\n* Patient with education level 3 \"end of primary education\"\n* Patient with a good command of the French language\n* Patient with access to the Internet from a computer at home\n* Patient having signed the consent to participate in the study\n* Patient with no pre-existing cognitive impairment at the time of cancer diagnosis\n* Patient with a sleep complaint (ISI \\> 7)\n\nExclusion Criteria:\n\n* Patient with metastatic cancer\n* Patient with a primary cancer other than breast cancer\n* Patient with a history of neurological damage\n* Patient with treated sleep apnea\n* Patient with drug use or alcohol abuse (≥3 drinks\u002Fday on average and\u002For \\>10 drinks\u002Fweek)\n* Patient with a treatment that has not been stabilized for at least 3 months (hypnotics, antidepressants, anxiolytics)\n* Patient with a personality disorder and\u002For an evolving psychiatric pathology\n* Patient with a contraindication to MRI (claustrophobia, metallic objects in the body)\n* Patient with an uncorrected vision problem",true,"45 Years",{"count":399,"type":20},75,[162],"Patients treated for breast cancer frequently complain of sleep disturbances, about 40% of them. Of the sleep disturbances experienced by patients, insomnia is the most common complaint. The prevalence of insomnia complaints is higher in breast cancer patients compared to other types of cancer, and is also higher than in the general population (between 20% and 70% in breast cancer patients vs 30% in the general population). A recent study indicates that sleep complaints concern 25% of patients even before diagnosis, and 46% (including 18% complaining of insomnia) at the time of diagnosis, showing the negative impact of the announcement of the pathology on the subjective quality of sleep, and particularly on symptoms suggestive of insomnia. However, objective information on a modification of sleep patterns in breast cancer remains scarce and does not allow us to conclude. In particular, previous studies have focused only on the effects of chemotherapy and have not always included a control group, limiting the significance of their results. The links with cognitive and psychopathological processes and the underlying mechanisms are not clearly demonstrated in this pathology. Finally, taking into account patients' complaints, it appears necessary to limit sleep disorders in breast cancer in order to improve patients' quality of life using non-medicinal and easy-to-implement approaches.",[403,404,405],"Breast Cancer","Sleep","Quality of Life","2025-09-17",{"date":408,"type":36},"2025-09-22",{"date":410,"type":36},"2023-03-20",{"date":412,"type":20},"2027-09",{"name":42,"class":43},{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":21,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":434},"100414572","phase-2-talazoparib-and-avelumab-as-maintenance-therapy-in-platinum-sensitive-metastatic-or-locally-advanced-urothelial-carcinoma-100414572","NCT04678362","TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma","TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma: A Single-arm Phase 2 Trial","TALASUR","Inclusion Criteria:\n\n* Patient ≥18 years at the day of consenting to the study\n* Provision of informed consent prior to any study specific procedures\n* Histologically confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter (upper urinary tract), bladder or urethra. Both transitional cell and mixed transitional\u002Fnon-transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology.\n* Documented Stage IV disease (T4b, N0, M0; any T, N1-N3, M0; any T, any N, M1) not candidate to a curative treatment with surgery or radiotherapy at the start of first-line platinum-based chemotherapy.\n* Patient must have completed prior to inclusion a platinum-based (cisplatin or carboplatin) polychemotherapy for at least 4 cycles of chemotherapy (until 6 cycles maximum) and have a stable disease or a partial response (PR) or a complete response (CR) from the chemotherapy according to RECIST 1.1 criteria\n\n  * A minimum dose of 55 mg\u002Fm² of cisplatin is required in order to count for 1 cycle.\n* A minimum dose of carboplatin AUC 4.5 is required in order to count for 1 cycle\n* Eligibility based on this criterion will be established locally by the investigator by examining pre and post-chemotherapy radiological assessments (CT\u002FMRI)\n* Neoadjuvant or adjuvant chemotherapy is allowed (with a delay of at least 12 months between the last dose of neoadjuvant or adjuvant chemotherapy and the relapse)\n* Patient must be enrolled within 8 weeks after the last dose of chemotherapy and should start study treatment at least 3 weeks after the last dose of chemotherapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* Normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:\n* Hemoglobin ≥ 10.0 g\u002FdL (patient may have been transfused before inclusion)\n* Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL\n* Platelet count ≥100 G\u002Fl\n* Total bilirubin ≤1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) \u002F Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤2.5 x ULN unless liver metastases are present in which case they must be ≤5x ULN\n* Patient must have creatinine clearance estimated using the CKD equation of ≥ 40 mL\u002Fmin\n* Able to swallow and retain oral drug\n* Life expectancy \\> 12 weeks\n* Serum pregnancy test (for females of childbearing potential) negative at screening\n* Male patient able to father children and female patient of childbearing potential and at risk for pregnancy must agree to use 2 highly effective methods of contraception throughout the study and for at least 60 days after the last dose of treatments\n* Patient affiliated to a French Social Security System or a beneficiary of such a system\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations\n* Optional: provision of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (or subsection thereof) from the most recent primary or metastatic tumor biopsy\n\nExclusion Criteria:\n\n* Patient who has never received chemotherapy with a platinum salt (cisplatin or carboplatin) for advanced\u002Fmetastatic urothelial carcinoma\n* Patient who has previously received more than one line of chemotherapy for advanced\u002Fmetastatic urothelial carcinoma\n* Patient whose disease has progressed according to RECIST v1.1 criteria after the first line platinum-based chemotherapy for urothelial carcinoma. The cancer must not be in the progression phase at inclusion\n* Patient with known CNS metastases and\u002For carcinomatous meningitis\n* Other malignancy within the last 3 years except: adequately treated non-melanoma, skin cancer curatively treated, in situ cancer of the cervix, ductal carcinoma in situ (DCIS), localized prostate carcinoma without PSA relapse\n* Patient with myelodysplastic syndrome\u002Facute myeloid leukemia history or with features suggestive of MDS\u002FAML\n* Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patient with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are allowed.Current treatment with an immunosuppressant medicinal product or treatment within 7 days prior to inclusion, EXCEPT:\n\n  * Intra-nasal, inhaled or local steroids or local steroid injections (such as intra-articular injections)\n  * Systemic corticosteroids at physiological doses of ≤ 10 mg\u002Fday of prednisone or equivalent\n  * Steroids as premedication for hypersensitivity reactions (such as CT scan premedication)\n* Major surgery within 4 weeks or major radiotherapy within to starting experimental treatment. Previous palliative radiotherapy (≤ 10 fractions) for metastatic lesions is permitted provided that this has been completed at least one week prior to starting Talazoparib and Avelumab\n* Active viral infection (HIV, Hepatitis B\u002FC) or known history of positive test for HIV\n* Any previous treatment with PARP inhibitor or any immunotherapy (e.g. anti-CTLA-4 or anti-PDL1\u002F PD1)\n* Concomitant treatment with any drug on the prohibited medication list such as live vaccines, concomitant use of strong P-gp inhibitors (cf section \"Prohibited concomitant treatments\") or systemic corticoids at dose \\> 10 mg\u002Fday prednisone or equivalent. Live vaccines administered more than 30 days before study entry are permitted\n* Clinically significant (e.g. active) cardiovascular disease cerebral vascular accident\u002Fstroke in the 3 months prior to enrollment: myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (≥ New York Heart Association Classification Class II), serious cardiac arrhythmia requiring medication, uncontrolled high blood pressure, cerebrovascular accident, transient ischaemic attack\n* Patient considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease or any psychiatric disorder that prohibits obtaining informed consent\n* Pulmonary embolism or deep vein thrombosis within 3 months prior to inclusion (unless if stable, asymptomatic and treated with a low molecular heparin for at least 10 days prior to starting Talazoparib + Avelumab).\n* Pregnant or lactating woman;\n* Participation in another interventional study with a systemic anti-cancer treatment within 4 weeks prior to inclusion. Inclusion in observational or interventional studies not involving a health product is permitted. Patient with telephone follow up of toxicities and simple laboratory monitoring or other questionnaires alone may be included.\n* Patient unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication;Previous organ transplant including stem cell allotransplantation or double umbilical cord blood transplantation.\n* Patient with a known hypersensitivity to Talazoparib and Avelumab or any of the excipients of the product.\n* People who are vulnerable under the law (minors, adults under legal protection, people deprived of their freedom)\n* Other persisting toxicities related to previous anticancer treatments: \"Persisting toxicity related to prior therapy (NCI CTCAE Grade \\> 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.\"",{"count":423,"type":20},50,[23],"The main objectif is to determine the efficacy of a maintenance treatment combining Talazoparib and Avelumab after platinum-based chemotherapy in patients with locally advanced\u002Fmetastatic urothelial carcinoma.",[427],"Urothelial Carcinoma",{"date":408,"type":36},{"date":430,"type":36},"2021-06-01",{"date":432,"type":20},"2025-12",{"name":42,"class":43},14,{"id":436,"slug":437,"hasResults":11,"nctId":438,"briefTitle":439,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":136,"minAge":17,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":21,"phases":444,"briefSummary":445,"conditions":446,"keywords":448,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":362},"100527820","phase-2-hrd-tests-for-ovarian-cancer-100527820","NCT06152731","HRD Tests for Ovarian cancER","HERO","Inclusion Criteria:\n\n* Patient aged 18-year or more\n* Histologically documented high grade serous epithelial ovarian cancer, fallopian tube or peritoneum cancer\n* Newly diagnosed advanced (International Federation of Gynecology and Obstetrics \\[FIGO\\] stage III or IV) ovarian carcinoma, candidate to a first line platinum-based chemotherapy\n* Tumor tissue must be available for HRD analyses (FFPE tissue block) and\n\n  * Collected if possible during the initial surgery or the initial biopsy (before chemotherapy)\n  * With sufficient tumour surface area (\\> 25 mm²), with a final cellularity of at least 20%\n* Patient affiliated to an appropriate social security system\n* Patient signed consent form before any trial related activities\n\nExclusion Criteria:\n\n* Recurrent high grade serous epithelial ovarian cancer, fallopian tube or peritoneum cancer\n* Non epithelial or borderline ovarian cancer\n* Other tumor, for which the treatment may interfere with the ovarian cancer treatment and\u002For that may have a major impact on prognosis\n* Exclusive palliative setting\n* Patient deprived of liberty or placed under the authority of a tutor",{"count":443,"type":20},88,[23],"The study concerns patients with Invasive epithelial ovarian cancer, primary Fallopian tube carcinoma, ovarian-type peritoneal carcinoma, and with an indication of a first-line platinum-based chemotherapy.\n\nTo determine HRD status, 2 separate tests will be performed in the study:\n\n1. Giscar assay : developed by the sponsor\n2. myChoice assay\n\nIf one or two tests identifies a HRD status :\n\na PARP inhibitor treatment may be initiated according to current recommendations",[447],"Ovarian Cancer",[449,450,451,452],"HRD (Homologous Recombination Deficient)","GIScar","myChoice","platinum chemotherapy","2025-09-16",{"date":406,"type":36},{"date":456,"type":36},"2024-02-15",{"date":458,"type":20},"2031-06",{"name":42,"class":43},{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":136,"minAge":468,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":21,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":480,"locationsCount":5},"100518214","remotely-supervised-computerized-cognitive-stimulation-to-reduce-post-chemotherapy-cognitive-difficulties-in-patients-treated-for-localized-breast-cancer-100518214","NCT06027632","Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer","Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer: a Multicenter Randomized Controlled Trial","COG STIM 2","Inclusion Criteria:\n\n* Patient diagnosed with localized breast cancer\n* Age 18 or older,\n* Who have received adjuvant or neo-adjuvant chemotherapy and are currently undergoing adjuvant radiotherapy (ongoing hormone therapy, maintenance therapy other as target therapies or immunotherapy are permitted) until 6 months after end of radiotherapy.\n* Patients who report cognitive complaints that significantly impact their quality of life, as evaluated by the quality of life subscale of the FACT-Cog questionnaire. This subscale is composed by 4 questions:\n\n  1. I have been upset about these problems;\n  2. These problems have interfered with my ability to work;\n  3. These problems have interfered with my ability to do things I enjoy;\n  4. These problems have interfered with the quality of my life.\n\nPatients are eligible if their score on this subscale is at or below the 10th percentile, based on age guidelines and normative data (Lange et al., 2015), namely:\n\n* ≤ 8 for patients aged 30-49 years\n* ≤ 9 for patients aged 50-69 years\n* ≤ 10 for patients aged 70-89 years\n\n  * Patients who have completed at least three years of primary school education, as determined by the Barbizet scale,\n  * Patient with access to a functional laptop\u002Fcomputer with a keyboard, internet connection and an e-mail account - being able to use those tools alone,\n  * Fluent in French,\n  * Patients who have provided informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Personality disorder or any known progressive psychiatric pathology (e.g. schizophrenia),\n* Previous neurological history with ongoing cognitive symptoms (sequelae of head trauma, stroke, multiple sclerosis, epilepsy, neurodegenerative pathology, etc.),\n* Excessive alcohol intake or drug use, which could compromise participation to the intervention\n* Major visual and\u002For hearing deficit,\n* Patient who might not be able to complete neuropsychological testing, (including those with significant cognitive disorders that impede the completion of cognition tests, as determined by the cognitive screening test MoCA (MONTREAL COGNITIVE ASSESSMENT) and based on age and educational level according to GRECOGVASC (Reflection Group for Vascular COGnitive Assessment) normative data)\n* Already participating in a cognitive training program,\n* Refusal to participate,\n* Patient deprived of liberty or under guardianship,\n* Patient who might not be able to participate due to geographic, social or psychopathological reasons.","18 Months",{"count":470,"type":20},300,[162],"Investigator propose the first French randomized comparative study to assess the efficacy of a remotely supervised online cognitive stimulation program, compared to an unsupervised online cognitive exercise intervention, in reducing cognitive complaints in localized breast cancer patients after adjuvant chemotherapy. Previous randomized studies have confirmed the effectiveness of online cognitive stimulation programs compared to standard care. The study seeks to determine the added value of remote supervision by a neuropsychologist. The control group will have access to the same online cognitive exercises as the experimental group but without supervision. Investigator has chosen not to include a wait-list group as it would be unethical to deny patients with cognitive complaints the opportunity to participate in an intervention expected to benefit them. The secondary objective is to evaluate the benefit of the supervised digitalized cognitive intervention on objective cognitive impairment.\n\nThe research hypothesis is that incorporating personalized remote support with supervision from a neuropsychologist into a digitalized cognitive stimulation program will reinforce the effectiveness of the intervention on cognitive complaints. This will be achieved by improving participation\u002Fadherence to the online cognitive stimulation program, as well as through the personalized supervision itself. Investigator believe that the supervision sessions, including educational components, will enable patients to identify their strengths, promote their cognitive awareness, and develop individualized strategies to apply their compensatory abilities in real-life situations. Since cognitive difficulties have multiple underlying causes, reducing these symptoms requires a multifaceted approach. The hypothesis is that combining cognitive training (which increases neuroplasticity and directly targets the cognitive domains affected by cancer and its treatments), with structured supervised educational sessions based on compensatory strategies, will yield better outcomes than online cognitive stimulation alone.",[403,474],"Cognitive Dysfunction",{"date":476,"type":36},"2025-09-19",{"date":478,"type":36},"2024-02-09",{"date":40,"type":20},{"name":42,"class":43},{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":396,"sex":136,"minAge":489,"maxAge":490,"enrollmentInfo":491,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":492,"conditions":493,"keywords":499,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":150},"100577009","measurement-of-circulating-mutation-burden-100577009","NCT06792721","MEASUREMENT OF CIRCULATING MUTATION BURDEN","EVALUATION OF CANCER RISK BY MEASUREMENT OF CIRCULATING MUTATIONAL BURDEN IN CARRIERS OF A GENETIC PREDISPOSITION","cRISK","Inclusion Criteria:\n\n* Female participant\n* Participant undergoing oncogenetic follow-up at the Centre François Baclesse\n* Participant belonging to a pair of related biological siblings\n* Within the sibling pair, one participant is a carrier of a hereditary predisposition linked to a BRCA1\u002F2 mutation (case), and the other participant is not a carrier (control).\n* Participant between 30 and 50 years of age\n* Participant affiliated to a social security scheme\n* Participant having given her consent to participate by signing an informed consent form prior to any specific study-related procedure.\n\nExclusion Criteria:\n\n\\-","30 Years","50 Years",{"count":257,"type":20},"Cancer-free women with a hereditary predisposition to breast and\u002For ovarian cancer",[494,495,496,497,498],"Breast Carcinoma","Genetic Predisposition to Cancer","BRCA Mutation","cfMB","Mutation Burden",[497,500,501,502,503],"predisposition to cancer","BRCA1","BRCA2","breast cancer","2025-07-07",{"date":506,"type":36},"2025-07-08",{"date":508,"type":36},"2025-07-04",{"date":510,"type":20},"2027-12-30",{"name":42,"class":43},{"id":513,"slug":514,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":11,"sex":16,"minAge":520,"maxAge":265,"enrollmentInfo":521,"targetDuration":4,"studyType":21,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":44},"100518912","neurocognitive-impact-of-different-irradiation-modalities-for-patients-with-grade-i-ii-skull-base-meningioma-100518912","NCT06036706","Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma:","Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma: A Prospective Multi-Arm Cohort Study","CANCER-COG","Patients:\n\nInclusion Criteria:\n\n* Benign meningioma (grade I), or atypical meningioma (grade II)\n* Histologic proven of benign meningioma, atypical meningioma or unequivocal radiological diagnosis of skull base meningioma if biopsy is recused.\n* Indication of irradiation validated by a multidisciplinary meeting\n* Age \\>20 years and \\\u003C65 years\n* Expected overall survival \\>10 years\n* Adjuvant or exclusive irradiation is allowed.\n* Signed informed consent form\n* WHO Performance status equal to 0 or 1\n* Patient affiliated to the French social health insurance\n* Patient whose neuropsychological abilities allow to follow the requirements of the protocol\n\nExclusion Criteria:\n\n* Patient with mutation in a known predisposition gene (NF-2, SMARCE-1).\n* Cerebrovascular pathology, presence of other tumors of the nervous system, congenital malformations of the nervous system, multiple sclerosis, Parkinson's disease, organic psychosis (other than dementia), or schizophrenia.\n* Other localization than skull base meningioma\n* Histology\u002Fradiological features rather different than grade I-II meningioma\n* Histologic proven grade III meningioma\n* Uncontrolled epilepsy\n* Contraindication to MRI\n* Patient with a history of brain irradiation.\n* Patient with a history of cancer in the last five years (excluding skin baso-cellular carcinoma)\n* Pregnant\u002Fbreastfeeding woman\n* Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study\n* Participation in a therapeutic trial evaluating a radiotherapy schedule or a new drug or combination for less than 30 days\n* Patient deprived of freedom or under guardianship\n* Hypersensibility to Gadolinium\n\nParticipants free of brain disease or cancer history:\n\nInclusion Criteria:\n\n* Subject without any history of neurological disease (cerebral stroke, epilepsy, Intra cranial Neurosurgery procedure, meningioma, pituitary adenoma, Parkinson disease,Dementia…) or absence of personality disorders and progressive psychiatric pathology\n* Age \\>20 years and \\\u003C65 years\n* Signed informed consent form\n* WHO Performance status equal to 0 or 1\n* Subject affiliated to the French social health insurance\n* Subject whose neuropsychological abilities allow to follow the requirements of the protocol\n* No major cognitive disorder that may compromise the realization of cognitive evaluations, defined as a MoCA score in accordance with the threshold depending on age and educational level according to the GRECOGVASC normative data\n\nNon-inclusion criteria\n\n* Cerebrovascular pathology, presence of other tumors of the nervous system, congenital malformations of the nervous system, multiple sclerosis, Parkinson's disease, organic psychosis (other than dementia), or schizophrenia\n* History of epilepsy with antiepileptic drug\n* Subject with a history of brain irradiation\n* Subject with a history of cancer in the last five years (Excluding skin baso-cellular carcinoma)\n* Pregnant\u002Fbreastfeeding woman\n* Any geographical conditions, social and associated psychopathology that may compromise the subject's ability to participate in the study\n* Participation in a therapeutic trial - Subject deprived of freedom or under guardianship","20 Years",{"count":522,"type":20},108,[162],"For the purpose of this research, investigator will constitute several cohorts of patients, treated either by intensity-modulated radiotherapy, stereotactic radiotherapy or proton-therapy. This will allow better understanding the cognitive and anatomical damages caused by new radiotherapy techniques and better understanding how ionising radiation (X-rays or protons) acts in the long term on brain tissue. Longitudinal follow-up will be multimodal, based on yearly multi-parametric brain MRI to assess morphological changes, in relation with dosimetric data as well as neuropsychological performances, health-related quality of life, anxiety and depression disorders, memory tasks, and socio-professional reintegration. This will notably make it possible to evaluate the relationship between dosimetric data, age at the time of treatment, region of the brain irradiated, type of radiation used, dose per fraction, neurocognitive and neuro-anatomical consequences. A Normal Tissue Control Probability (NTCP) model will be also developed. Overall, the results of this study should contribute to the improvement of treatment techniques, in particular by preserving as much as possible the significant cerebral zones (hippocampi, frontal lobe, sub-ventricular zones, etc.), and to the management of patients by proposing appropriate support measures. In the proton-therapy cohort, evaluations will make it possible to establish more precisely the place that this new irradiation strategy should occupy in the management of low grade meningioma. Importantly, investigator have planned to constitute a last cohort, with subjects free of any neurological disease, to make it easier the interpretation of cognitive performances over time among patients in the three brain radiation cohorts.",[526,527],"Meningioma","Radiation Toxicity","2025-06-18",{"date":530,"type":36},"2025-06-24",{"date":532,"type":36},"2023-09-13",{"date":534,"type":20},"2039-06",{"name":42,"class":43},{"id":537,"slug":538,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":21,"phases":546,"briefSummary":547,"conditions":548,"keywords":550,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":362},"100339221","phase-2-stereotactic-radiotherapy-for-cerebral-metastases-with-recent-hemorrhagic-signal-100339221","NCT03696680","Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal","Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps","STEREO-HBM","Inclusion Criteria:\n\n* Age\\> 18 years\n* Performance Status 0 or 1\n* Patient with less than 4 brain metastases \\[of a solid tumor, including melanoma, with a histologically proven diagnosis for the solid tumor; Patients who have had a metastasectomy and 1 to 3 brain metastatic lesions are eligible.\n* Brain injury (s) measuring between 5 and 30 mm in diameter\n* Patient eligible for stereotactic radiotherapy after a decision of the multidisciplinary committee\n* Presence of intra-tumor bleeding signals on at least one brain injury before stereotactic irradiation and defined by :\n\n  * hyperdense lesion on the non-injected CT (treatment scanner) and \u002F or,\n  * spontaneously hyperintense lesion on T1 MRI sequences without gadolinium injection and \u002F or,\n  * lesion with hypo signal on T2 sequences \\*\n* Absence of meningeal tumor invasion\n* Absence of brainstem metastasis\n* DS-GPA depending on the histological type (https:\u002F\u002Fbrainmetgpa.com\u002F#start):\n\n  * Lung Adecarcinoma: DS-GPA 2 or +\n  * Non-adenocarcinoma lung: DS-GPA 2.5 or +\n  * Kidney: DS-GPA 2.5 or +\n  * Breast: DS-GPA 2.5 or +\n  * Digestive cancer: DS-GPA 3 or +\n  * Melanoma: DS-GPA 1.5 or +\n* Patient without concomitant anti-cancer therapy (chemotherapy, hormone therapy, anti-angiogenic or other anti-cancer treatments). Treatments should be suspended for at least 7 days before the start of FSRT radiotherapy. The treatment can be resumed 7 days after the end of radiotherapy. It's not mandatory to suspend immunotherapy\n* Life expectancy estimated at over 6 months\n* Patient cooperating sufficiently to perform the treatment with the use of a thermoformed mask\n* Patient whose neuropsychological capacities make it possible to follow the requirements of the protocol\n* Patient affiliated to a social security scheme\n* Patient giving written consent\n\nExclusion Criteria:\n\n* Patient with small cell lung cancer, germ cell tumors, lymphoma, leukemia and multiple myeloma\n* Patient with a concomitant neurodegenerative disease\n* Any symptoms not attributable to cerebral metastasis or cancerous pathology and requiring long-term use of corticosteroids (regardless of dose)\n* Contraindication to brain MRI or gadolinium injection\n* Hemorrhagic disorders other than intra-tumor bleeding from brain lesion (s)\n* Radiosensitizing systemic disease (Neurofibromatosis ...)\n* Thrombocytopenia less than 100,000 cells \u002F mm3\n* Anticoagulant treatment, and \u002F or anti-platelet aggregation with curative et prophylaxic dose during FSRT. If treatment can be delayed for at least 5 days before starting FSRT and resumed 2 weeks after completion of FSRT, the patient is eligible.\n* Hemorrhagic metastasis (s) of the brainstem\n* Planning of the treatment on the target metastasis delivering a dose\\> 5 Gy on other metastases concomitant\n* Patient with prior cerebral stereotactic irradiation\n* History of total brain irradiation\n* Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study\n* Participation in a therapeutic trial that could compromise the conduct of study\n* Patient deprived of liberty or under guardianship",{"count":545,"type":20},46,[23],"This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases",[549],"Hemorrhagic Brain Metastases",[551,552,553,554],"hemorrhagic","brain metastases","FSRT","Stereotactic radiation therapy","2025-02-07",{"date":557,"type":36},"2025-02-11",{"date":559,"type":36},"2019-01-16",{"date":561,"type":20},"2028-01",{"name":42,"class":43},{"id":564,"slug":565,"hasResults":11,"nctId":566,"briefTitle":567,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":21,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":150},"100445632","circulating-immunes-cells-cytokines-and-brain-radiotherapy-100445632","NCT05082961","Circulating Immunes Cells, Cytokines and Brain Radiotherapy","CYRAD","Inclusion Criteria:\n\n* Patients \\> 18 years\n* Head and neck cancer: (upper aerodigestive tract, cavum, facial sinus, skull base, brain) operated\n* Surgery for complete tumour resection or with microscopic residue R1\n* All possible histologies: squamous cell carcinoma, undifferentiated carcinoma of the nasopharyngeal type (UCNT), adenocarcinoma, adenoid cystic carcinoma, chordoma, chondrosarcoma,meningioma other tumours\n* Patients undergoing exclusive postoperative radiotherapy with a minimum total dose of 54 Gy of X-ray photon radiation or equivalent proton radiation.\n* Patient affiliated to a social security scheme\n* Signature of the informed consent before any specific procedure related to the study\n\nExclusion Criteria:\n\n* Macroscopic postoperative tumour residue R2\n* Previous cancer within 5 years (except treated basal cell skin carcinoma and treated cervical cancer).\n* Previous radiotherapy (except brachytherapy of the cervix or prostate)\n* Chemotherapy or other systemic oncological treatment (cetuximab) concomitant with radiotherapy\n* Long-term immunosuppressive or corticosteroid therapy\n* Patient deprived of liberty or under guardianship, protected adult\n* Patient unable to undergo trial monitoring for geographical, social or psychopathological reasons\n* Pregnant or breastfeeding woman\n* Emergency situations",{"count":571,"type":20},40,[162],"Patients with malignant tumours of the cephalic pole have a poor prognosis, despite a wide range of treatments. prognosis despite a large therapeutic arsenal. Among this arsenal, radiotherapy (RT) is one of the standard treatments for these tumours. However, this treatment can cause damage to the surrounding healthy tissue, has limited efficacy in hypoxic However, this treatment can cause damage to the surrounding healthy tissue, has limited efficacy in hypoxic tissue and can promote pro-tumour inflammation.\n\nIn these circumstances, hadrontherapy, which uses charged heavy particles, such as protons or carbon ions, is the preferred treatment. protons or carbon ions, seems more appropriate for the treatment of these tumours. However, although inflammation plays a major role in tumour development and tumour development and therapeutic response, few studies have evaluated the immune response response after proton therapy (PT) and carbon therapy (CT). The objective of this project is to study the effect of hadrontherapy on resident\u002Fcirculating inflammation after brain irradiation. brain irradiation. In a first step, the impact of different PT and CT TEL on macrophages (M\\&#1060;), the most abundant immune cells in malignant solid tumours, will be evaluated in vitro. malignant solid tumours, will be evaluated in vitro. In a second step, the evolution of circulating leukocytes after brain irradiation with X-rays or protons will be studied in vivo in rodents and patients. rodent and patient. In this project, we propose to study for the first time the inflammatory response after hadrontherapy in the context of a cephalic tumour. cephalic tumour. These results will allow a better understanding of the biological response response following PT and CT with the aim of optimising RT and potentially and potentially translate these data to the clinic.",[117],"2024-12-06",{"date":577,"type":36},"2024-12-11",{"date":579,"type":36},"2022-01-27",{"date":581,"type":20},"2028-10",{"name":42,"class":43},{"id":584,"slug":585,"hasResults":11,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":11,"sex":136,"minAge":17,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":591,"conditions":592,"keywords":594,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":150},"100562464","collection-of-endometrial-cancer-derived-organoids-to-evaluate-the-efficacy-of-parp-inhibitors-pendor-pilot-study-100562464","NCT06603506","Collection of Endometrial Cancer-derived Organoids to Evaluate the Efficacy of PARP Inhibitors: PENDOR Pilot Study","PENDOR","Inclusion Criteria:\n\n* Patient aged 18 years or more\n* Patient with histologically confirmed, localized endometrial cancer, candidate for surgical treatment.\n* Patient with localized endometrial cancer, presenting:\n\n  * A high-grade endometrioid histological type and\u002For\n  * P53 mutation and\u002For\n  * a non-endometrioid histological type regardless of P53 status.\n* Patient affiliated to a social security scheme\n* Information and signature of informed consent prior to any specific study procedure\n\nExclusion Criteria:\n\n* Other active cancer less than 6 months old (with the exception of treated basal cell carcinoma of the skin).\n* Patient deprived of liberty, under guardianship, or subject to a legal protection measure, or unable to express consent.",{"count":104,"type":20},"This study comprises 3 stages:\n\n1. Collection of tumor and blood samples.\n2. Creation of organoid models based on tumor samples.\n3. Development of functional tests to predict clinical response to treatment.",[593],"Endometrial Cancer",[595,596,597],"endometrial cancer","organoide","PARP inhibitor","2024-11-25",{"date":600,"type":36},"2024-11-26",{"date":602,"type":36},"2024-11-21",{"date":604,"type":20},"2027-10-15",{"name":42,"class":43},{"id":607,"slug":608,"hasResults":11,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":21,"phases":616,"briefSummary":617,"conditions":618,"keywords":621,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":630,"locationsCount":631},"100421381","phase-2-interest-of-bilateral-basic-tongue-mucosectomy-assisted-by-robot-or-laser-in-combination-with-tonsillectomy-in-the-assessment-of-prevalent-cervical-lymphadenopathy-100421381","NCT04767048","Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy","Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy: a Randomized Phase II Study","RoboCUP","Inclusion Criteria:\n\n* Patient with a prevalent head and neck lymphadenopathy with positive or non-contributory fine needle aspiration, or having had an adenectomy revealing a metastasis of squamous cell carcinoma, a PET examination, an injected cervico-thoracic CT and an ENT work-up (nasofibroscopy) not finding a primary tumor\n* Performance Status \\\u003C 2\n* Patient aged 18 or over\n* Patient affiliated with social security system\n* Informed consent signed\n\nExclusion Criteria:\n\n* History of squamous cell carcinoma of the VADS or skin of the face.\n* History of cervico-facial radiotherapy\n* Primary tumor discovering during pan-endoscopy\n* Inexposable patient lead not to possible mucosectomy\n* Uncontrollable hemostasis disorders (contraindication to tonsillectomy and basic bilateral mucosectomy of language)\n* Distant metastases\n* Lymphadenopathy inoperable\n* Patient with a contraindication to radiotherapy\n* Pregnant or breastfeeding woman\n* Women of childbearing potential without effective contraception\n* Patient under guardianship or unable to give informed consent\n* Patient unable to undergo the trial follow-up for geographic, social or psychopathological reasons",{"count":615,"type":20},72,[23],"We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy",[619,620],"Cancer of Head and Neck","Adenopathy",[622,623],"mucosectomy","tonsil","2024-10-10",{"date":626,"type":36},"2024-10-15",{"date":628,"type":36},"2021-06-30",{"date":40,"type":20},{"name":42,"class":43},5,{"id":633,"slug":634,"hasResults":11,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":11,"sex":136,"minAge":17,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":21,"phases":642,"briefSummary":643,"conditions":644,"keywords":646,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":655,"locationsCount":656},"100457807","evaluation-of-the-impact-of-taking-american-ginseng-for-8-weeks-on-fatigue-in-patients-treated-for-localized-breast-or-gynecological-cancer-100457807","NCT05241405","Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer","Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer - Randomized, Placebo-controlled, Double-blind Study","QISEIN","Inclusion Criteria:\n\n* Patients with localized breast or gynecological cancer treated as curative adjuvant and\u002For neoadjuvant chemotherapy and\u002For adjuvant radiotherapy. These treatments must have been completed within 6 months of inclusion.\n\n  * Patient reporting a chronic, stable fatigue state at investigator assessment, defined as a fatigue score ≥ 4 on the visual analog scale rated up to 10, experienced for at least one month\n  * Maintenance therapy with hormone therapy or other maintenance therapy (trastuzumab, bevacizumab…) is allowed before and\u002For during the study (except for pembrolizumab, abemaciclib and PARP inhibitors, which are not authorized)\n  * Patient 18 years of age or older\n  * Effective contraception in women of childbearing age\n  * Patient affiliated to a social security plan\n  * Signed informed consent\n\nExclusion Criteria:\n\n* Other identified causes of fatigue (anemia of grade \\&gt; 2, underlying chronic disease known to be associated with fatigue)\n* Ongoing chemotherapy (patients scheduled for oral capecitabine or trastuzumab-emtasin in the adjuvant setting are not eligible)\n* Metastatic breast or gynecological cancer\n* Ongoing treatment with a tyrosine kinase inhibitor or other P-gp transported molecule or Pembrolizumab or PARP inhibitors\n* Patient requiring oral diabetes therapy\n* Regular intake of Vitamin C (in addition to what is provided by the diet)\n* Patients with chronic pain requiring daily treatment with analgesics, anti-inflammatory drugs or corticosteroids\n* Consumption of ginseng-based products in the month prior to inclusion\n* Hypersensitivity to any of the components of Qiseng or placebo\n* Pregnant or breastfeeding patient\n* Simultaneous participation in another therapeutic clinical trial (trial using an experimental product)\n* Patient deprived of liberty, under guardianship or curatorship\n* Patient unable to undergo the medical follow-up of the trial for geographical, social or psychopathological reasons\n* History of any other malignant disease during the last 3 years, except for skin cancer other than melanoma, carcinoma in situ of the uterus. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no signs of recurrence for at least 3 years",{"count":641,"type":20},354,[162],"This is a multicenter randomized trial in breast cancer patients reporting cancer-related fatigue to evaluate the efficacy and safety of Qiseng® based on extract of American ginseng combined with vitamin C from extract of Camu Camu berries",[403,645],"Fatigue",[647,648],"Qiseng","food supplement","2024-09-30",{"date":651,"type":36},"2024-10-01",{"date":653,"type":36},"2022-09-27",{"date":412,"type":20},{"name":42,"class":43},10,""]