[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institut Cancerologie de l'Ouest\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":501},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,48,76,110,137,165,191,218,240,265,286,313,338,367,389,415,443,470],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100641320","stereotactic-radiotherapy-for-spinal-metastases-with-limited-extent-of-epidural-disease-100641320",false,"NCT07656883","Stereotactic Radiotherapy for SPinal Metastases With Limited Extent of Epidural Disease","SPEED-RT","Inclusion Criteria:\n\n* Histologically confirmed solid tumor;\n* Vertebral bone metastasis located between C2 and S1 (inclusive) with epiduritis (spinal cord or cauda equina) without clinical and\u002For radiological spinal cord compression on MRI;\n* Performance status (PS) ≤ 1;\n* Spinal Instability Neoplastic Score (SINS) ≤12;\n* Patient has been informed and has provided freely given, written, and signed informed consent;\n* Patient is affiliated with or a beneficiary of the national health insurance system.\n\nExclusion Criteria:\n\n* Neurological deficit attributable to spinal cord compression or cauda equina syndrome;\n* Patient experiencing pain that prevents lying down for 30 minutes despite optimal analgesic treatment;\n* Life expectancy ≤6 months as estimated by the investigator;\n* Neurosurgical indication (preventive or decompressive) prior to radiotherapy;\n* More than one epiduritis lesion requiring treatment;\n* Prior surgery on the same vertebra targeted in the protocol;\n* Epiduritis and\u002For bone lesion extending over more than three contiguous vertebral levels;\n* Previous irradiation of the spine with cumulative dose with cumulative spinal cord dose EQD2 \\>50 Gy, α\u002Fβ = 2;\n* Contraindication to MRI;\n* Pregnant or breastfeeding woman;\n* Patient under legal protection, guardianship, or unable to provide informed consent;\n* Inability to comply with study follow-up due to geographic, social, or psychological reasons.","ALL","18 Years",{"count":19,"type":20},167,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study evaluates a new radiation treatment approach for patients with cancer that has spread to the spine (vertebral metastases) and involves limited extension around the spinal cord without causing compression (non-compressive epiduritis). This condition is common and can lead to serious complications, including pain and spinal cord compression, potentially affecting mobility and quality of life.\n\nThe current standard of care is conventional radiotherapy, which is effective for symptom relief but may provide limited long-term tumor control. As advances in cancer treatments have improved survival, there is an increasing need for treatment approaches that better prevent local tumor progression in the spine.\n\nThis randomized clinical trial compares standard radiotherapy with stereotactic radiotherapy (SRT), an advanced and highly precise radiation technique that delivers higher doses directly to the tumor while minimizing exposure to surrounding healthy tissues, including the spinal cord.\n\nThe primary objective is to determine whether SRT can improve local disease control while maintaining an acceptable safety profile. The study will evaluate the proportion of patients who are alive without spinal disease progression (including spinal cord compression or local tumor recurrence) at one year after treatment. Secondary outcomes include treatment-related side effects, time to disease progression, overall survival, quality of life, feasibility of delivering SRT within a defined timeframe, risk of vertebral fractures, and need for additional radiation treatment.\n\nEligible patients will have an estimated life expectancy greater than six months. Strict radiation dose constraints will be applied to minimize the risk of spinal cord injury, and patient safety will be closely monitored, including implementation of an early stopping rule in case of unexpected severe toxicity.\n\nThe hypothesis of the study is that stereotactic radiotherapy will improve local control of spinal metastases compared with standard radiotherapy, without increasing the risk of serious adverse effects.",[26,27],"Epiduritis","Vertebral Bone Metastasis",[29,30,31,32,33,34],"Epidural Disease","Spinal Cord Compression","Palliative Radiotherapy","Spinal Metastases","Stereotactic Body Radiotherapy (SBRT)","Radiation Therapy","NOT_YET_RECRUITING","2026-06-16",{"date":38,"type":39},"2026-06-18","ACTUAL",{"date":41,"type":20},"2026-10",{"date":43,"type":20},"2030-10",{"name":45,"class":46},"Institut Cancerologie de l'Ouest","OTHER",14,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100593506","early-phase-1-evaluation-of-the-value-of-68gaga-pentixafor-pet-ct-in-patients-with-metastatic-small-cell-lung-cancer-sclc-100593506","NCT07007325","Evaluation of the Value of [68Ga]Ga-PENTIXAFOR PET-CT in Patients With Metastatic Small Cell Lung Cancer (SCLC)","Prospective Feasibility Pilot Study Evaluating the Value of [68Ga]Ga-PENTIXAFOR PET-CT in Patients With Metastatic Small Cell Lung Cancer (SCLC) at Diagnosis and Disease Progression","PASSIFLORE","Inclusion Criteria:\n\n1. Written informed consent signed before performing any trial specific procedure.\n2. Male or female, age ≥ 18 years at time of study entry.\n3. Patient with histologically proven small cell lung carcinoma, inoperable, non-pre-treated.\n4. Metastatic disease documented by conventional imaging and\u002For \\[18F\\]FDG PET-CT with at least one metastatic measurable lesion (RECIST 1.1). Patients eligible for 1st line metastatic treatment.\n5. Availability of tissue material (primary lesion and\u002For metastatic site) to allow additional immunohistochemical studies.\n6. PS \\\u003C 2.\n7. Consent to use a contraception method for at least 3 months after each administration of \\[68Ga\\]Ga-PentixaFor.\n8. Adequate Organ function confirmed by laboratory test results allowing for safe the \\[68Ga\\]Ga-PentixaFor administration.\n9. Life expectancy greater than 3 months.\n10. Patient has valid health insurance.\n11. Patient willing and able to comply with the protocol throughout the duration of the study, including during treatment and scheduled visits and examinations, including follow-up.\n\nExclusion Criteria:\n\n1. History of cancer in the 3 years prior to entry into the trial other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n2. History of anti-cancer treatments such as chemotherapy, radiotherapy or immunotherapy as well as other clinical trials for SCLC before the first \\[68Ga\\]Ga-PentixaFor PET-CT imaging.\n3. Inability to lie still for at least 1 hour, or known claustrophobia.\n4. Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic) which may interfere with study objectives or patient safety or compliance, in the judgment of the investigator.\n5. Unstable diabetes with blood glucose \\> 2 g\u002FL.\n6. Known hypersensitivity to any active pharmaceutical agent or constituent of the \\[68Ga\\]Ga-PentixaFor and\u002For \\[18F\\]FDG product.\n7. Body weight of less than 48 kg.\n8. Mental impairment that may compromise the ability to give informed consent and comply with study requirements.\n9. Pregnant, likely to be pregnant or breastfeeding woman.\n10. Patient deprived of liberty, under judicial safeguard, under curatorship or placed under the authority of a guardian.\n11. Disorder preventing understanding of trial information or informed consent.",{"count":57,"type":20},15,[59],"EARLY_PHASE1","\\[68Ga\\]Ga-PentixaFor PET-CT will be performed in patients with Small cell lung cancer (SCLC) to confirm the targeting of CXCR4 by \\[68Ga\\]Ga-PentixaFor",[62],"Small Cell Lung Carcinoma (SCLC)",[62,64,65,66,67,68],"[68Ga]Ga-PentixaFor","immunohistochemistry (IHC)","CXCR4 expression","[18F]FDG","Safety",{"date":38,"type":39},{"date":71,"type":20},"2026-09-30",{"date":73,"type":20},"2030-09-30",{"name":45,"class":46},3,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100612944","phase-1-evaluation-of-ato-101-in-patients-with-non-muscle-invasive-bladder-cancer-perseverance-eu-100612944","NCT07260162","Evaluation of ATO-101™ in Patients With Non-Muscle-Invasive Bladder Cancer (PERSEVERANCE EU)","A First In Human Phase I Trial Evaluating Safety, Tolerability and Response of [211At]At-Girentuximab (ATO-101™) in Patients With Non-Muscle-Invasive Bladder Cancer Refractory to Standard Treatment","PERSEVERANCE","Inclusion Criteria:\n\n* Performance Status (PS): 0 or 1.\n* Patient experiencing relapse following standard treatment (BCG therapy with or without Mitomycin), before radical surgery which is being considered as a therapeutic option.\n* Clinical evidence of NMIBC based on cystoscopy and proven histologically of papillary tumours.\n* Histologically confirmed bladder cancer patients relapsing without muscle invasion.\n* Negative serum\u002Furine pregnancy test prior to ATO-101™ administration for female patient of childbearing potential.\n* Consent to use a contraception method for at least 3 months after administration of ATO-101™.\n* Adequate organ function confirmed by laboratory tests results allowing for safe administration of ATO-101™.\n\nExclusion Criteria:\n\n* Patient with urinary incontinence.\n* Patient treated with anticoagulant or platelet antiaggregant therapies.\n* Symptoms of urine infection.\n* Patient with urethral stenosis.\n* Patient with valvular heart disease.\n* No history of congestive heart failure.\n* Known hypersensitivity to Girentuximab.\n* Exposure to any experimental diagnostic or therapeutic drug within 30 days prior the date of planned administration of ATO-101™.\n* Serious non-malignant disease that may interfere with the objectives of the study or with the safety or compliance of the patient as judged by the investigator.\n* Concomitant cancer in the past 5 years except cutaneous cancers (except melanoma) and in situ carcinoma in past 3 years.\n* Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), immunotherapy within 21 days of ATO-101™ administration.\n* Pregnant or likely to be pregnant or nursing patient.",{"count":85,"type":20},24,[87],"PHASE1","Non-Muscle-Invasive Bladder cancer (NMIBC) tumours often recur despite TransUrethral Resection of Bladder (TURB) and Bacillus Calmette-Guerin (BCG) intravesical instillations, and have no effective conservative treatment options. Alpha emitters like Astatine-211 (211At), due to their short path and short half-life, show promise for superficial targets such as NMIBC.\n\nCarbonic anhydrase IX (CAIX), overexpressed in 70-90% of NMIBC cases but absent in healthy tissues, is an ideal target.\n\nA clinical feasibility Positron emission tomography-computed tomography (PET\u002FCT) imaging study (Pertinence, NCT04897763) was conducted at Institut de cancérologie Ouest (ICO) in six patients using Girentuximab labelled with Zirconium-89 (\\[89Zr\\]Zr-girentuximab). It demonstrated successful tracer targeting and no radioactive leakage beyond the bladder following intravesical instillation. The study also confirmed the absence of toxicity, contamination, or significant additional staff radiation exposure.\n\nATO-101™ (\\[²¹¹At\\]At-girentuximab) could enable localised tumour destruction while preserving the bladder in patients with BCG-unresponsive NMIBC. The ongoing First In Human (FIH) study evaluate the safety of ATO-101™ in patients with BCG-unresponsive NMIBC.",[90],"Bladder Cancer",[92,93,94,95,96,97,98,99,100],"Non-Muscle-Invasive Bladder cancer (NMIBC)","Girentuximab","Astatine 211","Phase I","First In Human (FIH)","Carbonic anhydrase IX (CAIX)","Intravesical instillation","[211At]At-Girentuximab","ATO-101™","2026-06-04",{"date":103,"type":39},"2026-06-08",{"date":105,"type":20},"2027-01",{"date":107,"type":20},"2030-01",{"name":45,"class":46},1,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":118,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":109},"100591274","highly-metastatic-life-prolonging-therapy-resistant-prostate-cancer-role-of-stereotactic-radiotherapy-for-bone-and-lymph-node-metastases-himars-100591274","NCT06978296","HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases (HIMARS)","HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases","HIMARS","Inclusion Criteria:\n\n* Metastatic prostate cancer with clinical progression after the use of androgen-receptor pathway inhibitor, chemotherapy or any other life-prolonging therapy. Patient could have been treated previously by RadioLigand Therapy (RLT).\n* Performance Status \\\u003C 3\n* Bone and\u002For lymph node metastases based on conventional (CT and bone scan) or metabolic imaging\n* Bone and\u002For lymph node metastases suitable for SRT, according to the investigator\n* Adequate organ function:\n\n  1. Absolute Neutrophil Count (ANC) ≥ 1000\u002Fmm3 or\n  2. Platelet Count ≥ 50 000\u002Fmm3 or\n  3. Haemoglobin ≥ 8 g\u002FdL (allowing transfusion or other intervention to achieve this minimum haemoglobin)\n* Age ≥ 18 years at time of study entry\n* Written informed consent obtained from the patient prior to performing any protocol-related\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Patient has valid health insurance\n* Life time expected \\> 3 months\n\nExclusion Criteria:\n\n* Evidence of symptomatic metastases to the lungs, brain, peritoneum or liver\n* Evidence of diffuse metastatic spread to the bone marrow (e.g. positive super bone scan) or the cerebral spinal fluid as per bone scan (no lumbar puncture required).\n* Evidence of presence of symptomatic spinal cord compression with indication of neurosurgical decompression.\n* Patient with symptomatic and\u002For high-risk tumor volume-to-bone marrow reserve ratio \\> 50%\n* Concurrent enrolment in another clinical study, unless it is a non-therapeutic clinical study\n* Mental impairment (psychiatric illness\u002Fsocial situations) that may compromise the ability of the patient to give informed consent and comply with the requirements of the study;\n* Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship;\n* Patients unable to undergo medical follow-up in the study for geographical, social or psychological reasons.\n* History of another primary malignancy except for\n\n  1. Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of SRT and of low potential risk for recurrence\n  2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  3. Adequately treated carcinoma in situ without evidence of disease\n* Uncontrolled pain that contraindicates patient positioning on the radiotherapy table according to investigator\n* Patient indicated to or currently treated by cytopenic treatment as chemotherapy or RadioLigand Therapy\n* Patient under concomitant treatment that may generate severe gastro-intestinal disorder or genito-urinary disorder","MALE",{"count":5,"type":20},[23],"The investigators propose redefining this concept by focusing on volume rather than the number of metastases. To achieve this, the investigators aim to determine the Maximum Tolerated Volume (MTV) of metastatic lesions treatable with SRT (Stereotaxic radiotherapy) in a phase 1 study. In this study, the investigators will recruit patients with high-volume metastatic disease in bones or lymph nodes and progressively irradiate a volume-escalated subset of the total lesions. The selection will prioritize lesions at higher risk of causing pain or complications, such as fractures, spinal compression, or vascular compression. The investigators hypothesis is that SRT targeting multiple metastases (with a total volume ≤ MTV) will extend the duration without refractory pain and\u002For tumor-related complications in patients with castration-resistant and chemo-refractory prostate cancer.",[123,124],"Prostate Cancer Metastatic Disease","Oligometastatic Prostate Cancer (OMPC)",[126,127,128],"Radiotherapy","Stereotaxic","oligometastatic","RECRUITING","2026-06-02",{"date":101,"type":39},{"date":133,"type":39},"2026-06-01",{"date":135,"type":20},"2030-07-01",{"name":45,"class":46},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":144,"minAge":4,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":109},"100640721","clinical-and-biological-study-of-early-onset-breast-cancer-and-the-influence-of-the-reproductive-cycle-on-the-aggressiveness-of-the-disease-100640721","NCT07601152","Clinical and Biological Study of Early-onset Breast Cancer and the Influence of the Reproductive Cycle on the Aggressiveness of the Disease","ARTEMIS","Inclusion Criteria:\n\n* Triple-negative breast cancer or RH+\u002FHER2-\n* Patient aged ≤ 45 years at the time of diagnosis ou Patient aged ≥ 55 years at the time of diagnosis\n\nExclusion Criteria:\n\n* Availability of a diagnostic tumor sample","FEMALE","45 Years",{"count":147,"type":20},1000,"OBSERVATIONAL","The incidence of breast cancer is increasing, particularly among young women. Cancers in young women are associated with a poor prognosis. The causes remain poorly understood.\n\nAmong young patients, some are nulliparous and others have reported cancer during or after pregnancy. Preliminary studies suggest that breast tissue remodeling associated with pregnancy may influence the emergence and aggressiveness of early-onset cancers. However, breastfeeding and pregnancy are described as protective factors against the onset of breast cancer. The precise biology depending on age and the time between pregnancy and breast cancer is still poorly understood.\n\nThe aim of our study is to increase our knowledge of cancer in young women and its potential links to pregnancy and breastfeeding. Information on the contraceptive habits and pregnancies of the patients in the study will be collected, and molecular and cellular analyses will be performed on frozen tumor samples as well as samples fixed and embedded in paraffin.",[151],"Breast Cancer",[153,154,155,156],"Early breast cancer","breastfeeding","pregnancy","reproductive cycle","2026-05-20",{"date":159,"type":39},"2026-05-22",{"date":161,"type":20},"2026-05",{"date":163,"type":20},"2031-02",{"name":45,"class":46},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":144,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":109},"100639107","efficacy-of-transcutaneous-auricular-vagus-nerve-stimulation-tavns-in-aromatase-inhibitor-induced-arthralgia-aia-100639107","NCT07575750","Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA)","Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA): a Phase 2, Randomized, Monocentric, taVNS Versus Sham, Double Blind","AROVAGUE","Inclusion Criteria:\n\n1. Menopausal women receiving an aromatase inhibitor (AI) as adjuvant treatment for breast cancer (letrozole (Femara), anastrozole (Arimidex) or exemestane (Aromasin)). The same AI must have been the same during the 4 weeks preceding inclusion and not be intended to be changed during the study period;\n2. Polyarticular and symmetrical pain that developed or worsened after the initiation of AI therapy and has persisted for at least 1 month;\n3. Score greater than 4 within 7 days before randomization (range,0-10; higher scores indicate greater pain) on the average pain item of the Brief Pain Inventory-Short Form (BPI-SF) as reported by patient;\n4. Patients receiving stable background analgesic treatment for AIA may be included, provided that this treatment has remained stable and that no new medication has been initiated prior to inclusion, as follows:\n\n   * Analgesic treatment: stable for at least 2 weeks before inclusion, with no initiation of new medication.\n   * Antidepressant treatment, including serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g., duloxetine, venlafaxine): stable for at least 4 weeks before inclusion, with no initiation of new medication.\"\n5. Patients with an Eastern Cooperative Oncology Group performance status of 0 to 2;\n6. Patient covered by a social security system;\n7. Patient mastering the French language and able to complete the evaluation questionnaires;\n8. Signed written informed consent form.\n\nExclusion Criteria:\n\n1. Patients who have previously used an electrostimulation device for pain management;\n2. Use of vagus nerve stimulation prior to the study;\n3. Patients who have received auriculotherapy for the same indication within the previous 4 weeks or who plan to initiate such treatment during the study;\n4. Symptomatic orthostatic hypotension (according to investigator) or recurrent vasovagal syncope or history of vagotomy;\n5. Previously implanted electrically active medical devices (eg, cardiac pacemakers or automatic implantable cardioverter defibrillators), or significant electrocardiogram abnormalities (cardiac rhythm disturbances, atrioventricular block \\>first degree or total bundle branch block);\n6. Current treatment with beta-blocker drugs;\n7. Patient under guardianship or unable to give informed consent;\n8. Patient unable to undergo medical follow-up for geographical, social or psychopathological reasons.",{"count":174,"type":20},60,[23],"Breast cancer (BCa) is the most common cancer in women. The majority of BCa are hormone receptor positive and substantial benefits have been demonstrated for adjuvant endocrine therapies in reducing recurrence and extending survival in women.\n\nAromatase inhibitors (AI) are commonly prescribed for women diagnosed with hormone receptor positive BCa. In parallel with this improvement in survival, women may experience a frequent adverse effect from AI therapy with arthralgia, or joint pain and stiffness. AI-induced arthralgia (AIA) is experienced by about 50 % of recipients.\n\nThe main AIA symptoms are joint pain and stiffness, mainly in the hands, wrists, and knees, symmetrically.\n\nAlthough AIA can occur at any time after initiating AI, the median time to onset is approximately 6 weeks with peak symptoms at 6 months.\n\nAdditionally, AIA impairs quality of life (QoL) and pain severity is associated with premature discontinuation and non-adherence to AI therapy which in turn is significantly associated with increased mortality in BCa patients.\n\nDeclining levels of oestrogen induced by AI results in increased production of proinflammatory cytokines hitting chondrocytes resulting in joint pain and swelling.\n\nThe autonomic nervous system (ANS) plays an important role in the regulation of inflammation. Dysregulation of the ANS is observed in women treated for BCa.\n\nAcupuncture, exercise, duloxetine, … have potential to improve AIA in BCa survivors, however, few studies have attempted to compare different modalities, resulting in a lack of evidence-based decision making for these interventions.\n\nA novel, non-invasive, wearable vagus nerve stimulation device has been created and has the potential to modulate proinflammatory cytokine production and reduce inflammation by affecting the functioning of the autonomic nervous system.\n\nSome studies have demonstrated the safety and efficacy of this device after several weeks of treatment, on the intensity of pain secondary to rheumatic diseases after several weeks of treatment.\n\nWe would like to study the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) for patients with aromatase inhibitor-induced arthralgia",[151,178],"Aromatase Inhibitor-induced Arthralgia",[180,181,182,183,184],"Aromatase inhibitors","aromatase inhibitor-induced arthralgia","Breast cancer","transcutaneous auricular vagus nerve stimulation (taVNS)","vagus nerve stimulation device",{"date":159,"type":39},{"date":187,"type":20},"2026-09",{"date":189,"type":20},"2028-12",{"name":45,"class":46},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},"100514655","prediction-in-silico-of-pathological-response-in-a-prospective-cohort-study-of-early-breast-cancer-patients-100514655","NCT05981326","Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients","NEOEPICURE","Inclusion Criteria:\n\n1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood samples and questionnaires\n2. 18 years old or at time of written consent\n3. Patient with histologically confirmed breast cancer\n4. Absence of metastatic disease\n5. Patient requiring neoadjuvant chemotherapy\n6. Performance status ≤ 2 (according to WHO criteria)\n7. Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and \u002F or international recommendations.\n8. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n9. Patient must be affiliated to a Social Health Insurance\n10. For patients taking part in the RTW WP: working patients at time of diagnostic and in sick leave at time of inclusion\n\nExclusion Criteria:\n\n1. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)\n2. Non epithelial breast cancer\n3. Coagulopathy or other pathology that contraindicates biopsy procedures\n4. Pregnant or nursing patient\n5. Individual deprived of liberty or placed under the authority of a tutor\n6. Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons\n7. For patients taking part in the RTW WP: patient in an \"self employed\" or \"interim\" employment situation\n8. For patients taking part in the RTW WP: Patients working part-timeProcedures for withdrawal of incorrectly enrolled patients are presented in Section 7.5.",{"count":199,"type":20},300,[23],"Breast cancer (BC) is the most common cancer in women in France with nearly 58,500 new cases and 12,150 deaths estimated in 2018 .\n\nTwo major achievements have been made in the last five years for breast cancer patients. The first is therapeutic with the approval of immune checkpoint inhibitors in advanced and early triple-negative BC (TNBC) and the impressive efficacy of new antibody-drug conjugated in all BC subtypes. The second is conceptual with the generalization of adaptive therapeutic strategies guided by pathological responses after neoadjuvant therapy in early TNBC, HER2+, HR+ and BRCA mutated breast cancer. This new paradigm in the treatment of cancer patients completely redefined prognostic factors that were previously established with conventional approaches Pathological response remains a major prognostic factor especially for TNBC and HER2 early breast cancer. However, this parameter is evaluated at the end of neoadjuvant treatment and for patients with residual disease, the prognosis remains poor despite some adaptative strategies.\n\nOur project is to integrate massive and heterogeneous data concerning the disease (clinical and biological data, imaging and histological results (with multi-omics data)) and patient's environment, personal and familial history. These data are multiple and have dynamic interactions overtime. With the help of mathematical units with biological competences and scientific collaborations, our project is to improve the prediction of treatment response, based on clinical and molecular heterogeneous big data investigation.\n\nThe main objective of this project is to set up a clinicobiological database prospectively by collecting prospective clinical, biological, pathological and multi-omic data from 300 Patients with early BC treated at the ICO in order to define an algorithm of individual decision for the prediction of the response to this treatment.",[151],[204,205,206,207,208],"Neo adjuvant chemotherapy","Multi omic analysis","Predilection in silico","Prospective clinico database","Surgery","2026-03-26",{"date":211,"type":39},"2026-03-31",{"date":213,"type":39},"2023-10-31",{"date":215,"type":20},"2033-04",{"name":45,"class":46},2,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},"100503845","phase-3-capsaicin-179-mg-patch-versus-oral-duloxetine-in-patients-with-chemotherapy-induced-peripheral-neuropathy-100503845","NCT05840562","Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy","Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy : a Phase 3 Randomized Multicentric Open-label Study.","CAPNEUCHIM","Inclusion Criteria:\n\n* Patient with CIPN manifested by painful symptoms such as numbness and \u002F or tingling and \u002F or burning pain in fingers \u002F hands and toes \u002F feet with a typical distribution in \"gloves and socks\" beginning after neurotoxic chemotherapy\n* Painful CIPN as expressed by the BPI-SF (average pain) as ≥ 4\u002F10\n* CIPN persisting at least 1 month after completion of chemotherapy with taxanes and\u002For platinum salts and sensory CIPN grade ≥ 2 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE v.5.0) grading scale\n* Stable doses in the 4 weeks before screening, of concomitant neuropathic pain medication (antiepileptic drugs)\n* Healthy and non-irritated skin on the areas to be treated\n* Absence of neurotoxic chemotherapy planned during the next 6 months after inclusion\n* Patient affiliated to a social security scheme\n* \\> 18 years old\n* Signed written informed consent form\n\nExclusion Criteria:\n\n* Presence of known carcinomatous meningitis\n* Pre-existing known peripheral neuropathy of another aetiology (alcohol, diabetes, …)\n* Hypersensitivity to Capsaicin or contra-indications to duloxetine (e.g imatinib, tamoxifen)\n* Patient already treated for this neuropathy with Capsaicin patches\n* Patient treated by antidepressant drugs at time of inclusion\n* Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 90 mmHg) or recent history (\\\u003C3 months) of cardiovascular events (stroke, heart attack, pulmonary embolism)\n* Patients with known severe renal or hepatic failure\n* Breastfeeding or pregnant women\n* Persons deprived of liberty or guardianship (including curatorship)\n* Patient unable to undergo regular medical follow-up for geographical, social or psychological.",{"count":227,"type":20},274,[229],"PHASE3","Chemotherapy induced peripheral neuropathy (CIPN) is a frequent and disabling complication of systemic chemotherapy, particularly with oxaliplatin or taxanes. The incidence of CIPN is variable but approximately 30-40% of patients treated with neurotoxic chemotherapy agents develop CIPN after long-term use of taxanes or oxaliplatin.\n\nThis CIPN is essentially a sensory peripheral neuropathy with pain manifested by unpleasant symptoms such as numbness, tingling, and less frequently shooting\u002Fburning pain. These symptoms spread proximally to affect both lower and upper extremities in a characteristic \"stocking and glove\" distribution.\n\nMany symptoms of CIPN may resolve completely for some patients. However, CIPN is only partly reversible for most. In the worst instances, it does not appear to be reversible at all and can even increase over time.\n\nCIPN is difficult to manage. Only duloxetine is recommended, based on the positive result of a randomized phase III double-blind placebo-controlled crossover trial. The use of duloxetine resulted in a greater reduction in pain and was effective in decreasing numbness and tingling in the feet. But, systemic antidepressants are often associated with toxicities and patients often refuse or abandon the treatment.\n\nCapsaicin inhibits neural transmission in sensory axons and has been proven as effective on the intensity of pain for post-herpetic neuralgia and human immunodeficiency virus-associated neuropathy. Efficacy appears at one month and persists for at least 2 months.\n\nOnly a few studies focused on the efficacy of capsaicin 179 mg patch on the intensity of CIPN-induced pain. These non-randomized studies show that more than 50% of patients have a reduction in pain intensity of more than 30%.\n\nUntil now, no clinical trial has compared the efficacy of the capsaicin 179 mg patch with duloxetine.\n\nAccordingly, this open-label phase 3, randomized, multicenter trial, will compare efficacy and safety of capsaicin patch with oral duloxetine on painful CIPN persisting more than 3 months after the end of the responsible chemotherapy.",[232],"Chemotherapy-induced Peripheral Neuropathy",{"date":211,"type":39},{"date":235,"type":39},"2023-10-20",{"date":237,"type":20},"2028-03",{"name":45,"class":46},11,{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":248,"targetDuration":250,"studyType":148,"phases":4,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":262,"leadSponsor":264,"locationsCount":4},"100628991","feasibility-study-of-urinary-cfdna-analysis-as-a-non-invasive-monitoring-tool-in-patients-with-prostate-or-bladder-cancer-100628991","NCT07468838","Feasibility Study of Urinary cfDNA Analysis as a Non-invasive Monitoring Tool in Patients With Prostate or Bladder Cancer","Feasibility Study of Circulating Tumour DNA Analysis in Urine (Urinary cfDNA) as a Non-invasive Monitoring Tool in Patients With Prostate or Bladder Cancer","UroDNA","Inclusion Criteria:\n\n1\\) Five patients for each of the following cancers :\n\n* Patients with high-risk localised prostate cancer eligible for high-dose radiotherapy, or\n* Patients with mHSPC eligible for docetaxel chemotherapy, or\n* Patients with mCRPC in second-line treatment eligible for luPSMA treatment, or\n* Patients with localised bladder cancer eligible for neoadjuvant chemotherapy or,\n* Patients with metastatic bladder cancer eligible for enfortumab vedotin (EV) plus pembrolizumab (EV-Pembro)\n\nExclusion Criteria:\n\n1. History of cancer in the 5 years prior to entering the trial other than basal cell skin cancer or cervical carcinoma in situ,\n2. Women who are pregnant, likely to become pregnant or breastfeeding,\n3. Persons deprived of their liberty, under judicial protection, under guardianship or placed under the authority of a guardian, Inability to undergo medical follow-up for the trial for geographical, social or psychological reasons.",{"count":249,"type":20},25,"6 Months","The UroDNA study is a feasibility study (RIPH category 3) aimed at evaluating the analysis of circulating tumour DNA in urine (urinary cfDNA) as a non-invasive monitoring tool in patients with prostate or bladder cancer. Urine samples will be collected at different times during the course of treatment to define the optimal conditions for cfDNA collection, extraction and analysis, and to explore the detection of tumour mutation profiles. This study does not involve any experimental treatment. Its objective is to validate the technical and clinical feasibility of a molecular monitoring urine test, which could offer a simple and non-invasive alternative to improve the management of urological cancers.",[253,90],"Prostate Cancer",[255,256,257],"urinary cfDNA","prostate cancer","bladder cancer","2026-03-12",{"date":260,"type":39},"2026-03-16",{"date":161,"type":20},{"date":263,"type":20},"2027-12",{"name":45,"class":46},{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":21,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":109},"100520027","thrombin-generation-and-prediction-of-thromboembolic-events-in-oncology-patients-at-risk-100520027","NCT06051214","Thrombin Generation and Prediction of Thromboembolic Events in Oncology Patients at Risk","THROMBIN","Inclusion Criteria:\n\n1. Patient aged \\> 18 years,\n2. Patient with a solid cancer at high risk of thrombosis, whether metastatic or not (lung, pancreatic, gastric or glioblastoma cancers)1,\n3. Patients who have not received any systemic treatment for their cancer,\n4. An informed patient who does not object to the use of data for research purposes and who has consented to the collection, use and storage of biological samples.\n\nExclusion Criteria:\n\n1. Patient who has had a VTE in the 12 months preceding the diagnosis of cancer,\n2. Patient on low molecular weight heparins, standard unfractionated heparins and anti-vitamin K2,\n3. Women who are pregnant, likely to become pregnant or who are breast-feeding,\n4. Persons deprived of their liberty, under court protection, under curators or under the authority of a guardian,\n5. Unable to undergo medical monitoring of the trial for geographical, social or psychological reasons.",{"count":273,"type":20},200,[23],"Coagulation is a complex system which, through the action of thrombin, leads to the formation of fibrin, which stabilises the platelet clot. Any disturbance in the balance between procoagulant and anticoagulant factors can tip the physiological process either towards a state of hypercoagulability leading to thrombosis or hypocoagulability responsible for bleeding.\n\nDue to a number of factors, cancer is associated with a state of hypercoagulability, leading to thrombosis. The incidence of venous thromboembolism (VTE) in cancer patients varies from 15 to 20% depending on the type of cancer, the stage of the disease and the associated treatments (ONCORIF data, November 2021). The risk of venous thromboembolism (VTE) is greatly increased in cancer patients (RR x 3 to 6) and doubled in the case of associated chemotherapy (1). VTE is a poor prognostic factor, occurs mainly in the first 6 months after diagnosis and is the second leading cause of death in cancer patients.\n\nAt present, haemostasis tests performed in medical laboratories independently explore the different coagulation pathways but do not allow the overall haemostatic profile of a hyper- or hypocoagulable patient to be assess.\n\nBased on this knowledge base, the aim of our study will be to monitor thrombogram profiles during the management of patients with tumours at high risk of thromboembolism (lung, pancreas, stomach, glioblastoma) and to correlate these profiles with the risk of a thromboembolic event occurring in these patients. The aim of the project is to validate a simple predictive test (suitable for clinical use) for the risk of thromboembolism in these patients. These analyses will also make it possible to monitor the impact of chemotherapy on changes in the thrombin generation test in patients.",[277],"Solid Carcinoma","2026-02-12",{"date":280,"type":39},"2026-02-17",{"date":282,"type":39},"2023-09-12",{"date":284,"type":20},"2028-09",{"name":45,"class":46},{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":21,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":109},"100590034","assessement-of-potential-interest-of-68gaga-pentixafor-petct-in-metastatic-triple-negative-breast-cancer-patients-100590034","NCT06962163","Assessement of Potential Interest of [68Ga]Ga-PentixaFor PET\u002FCT in Metastatic Triple Negative Breast Cancer Patients","Prospective Phase 0 Pilot Study, Assessing Potential Interest of [68Ga]Ga-PentixaFor PET\u002FCT in Metastatic Triple Negative Breast Cancer Patients","EXIGENCE","Inclusion Criteria:\n\n1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.\n2. Female or male, Age ≥ 18 years at time of study entry.\n3. Primitive triple negative breast cancer proven histologically, defined according to the following criteria:\n\n   * Estrogen receptors \\\u003C10%.\n   * And progesterone receptors \\\u003C10%.\n   * And HER2 not amplified or not overexpressed.\n4. Recurrence metastatic Breast Cancer or De Novo metastatic Breast Cancer documented by \\[18F\\]FDG PET\u002FCT ± conventional imaging with at least one measurable metastasis according to PERCIST and\u002For RECIST.\n5. ECOG performance status \\\u003C 2.\n6. Negative serum\u002Furine pregnancy test prior to \\[68Ga\\]Ga-PentixaFor administration for female patient of childbearing potential\\*.\n7. Consent to use a contraception method for at least 3 months after each administration of \\[68Ga\\]Ga-PentixaFor (as defined in Appendix 7 and according to local guidelines).\n8. Adequate Organ function confirmed by laboratory tests results allowing for safe administration of \\[68Ga\\]Ga- PentixaFor:\n\n   Hematologic function: Absolute Neutrophil Count (ANC) of ≥ 1.5 x 109 \u002FL, platelet count of ≥ 100 x 109 \u002FL, and hemoglobin of ≥ 9 g\u002FdL).\n\n   Hepatic function: AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastases).\n9. Renal function: Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL\u002Fmin\u002F1.73m², as calculated using the CKD-EPI or MDRD equation.Life expectancy at least 3 months.\n10. Patient has valid health insurance.\n11. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\n    * Note: a female participant of childbearing potential is a woman who is not permanently sterilized or not postmenopausal (postmenopausal is defined as 12 months with no menses without an alternative medical cause).\n\nExclusion Criteria:\n\n1. History of another primary malignancy within the last 3 years before study entry except for basal cell carcinoma.\n2. Impossibility to hold lying motionless at least 1 hour, or known claustrophobia.\n3. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator.\n4. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.\n5. Pregnant, likely to be pregnant or breastfeeding woman.\n6. Blood glucose \\> 12mmol\u002FL.\n7. Renal insufficiency with GFR ≤ 45 mL\u002Fmin\u002F 1.73 m².\n8. Known hypersensitivity to any active pharmaceutical agent or constituent of the \\[68Ga\\]Ga-PentixaFor and\u002For \\[18F\\]FDG product.\n9. Body weight of less than 48 kg.\n10. Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.\n11. Disorder precluding understanding of trial information or informed consent.",{"count":295,"type":20},12,[23],"Triple-negative breast cancer (TNBC) is a particularly aggressive type of breast cancer that is difficult to treat. Unlike other forms of breast cancer, TNBC tends to relapse earlier and spread more quickly to other parts of the body. Unfortunately, patients with TNBC have a lower survival rate, often less than five years after diagnosis. This highlights the urgent need for better treatments for TNBC.\n\nOne of the main challenges in treating TNBC is that it lacks certain receptors that other breast cancers have. These receptors are usually targeted by specific therapies, making TNBC harder to treat with targeted approaches.\n\nCurrently, a type of imaging called \\[18F\\]FDG PET\u002FCT is the most accurate method for detecting breast cancer and its spread. However, with the rise of personalized medicine, there is a growing interest in molecular targeted approaches. These methods aim to provide highly specific diagnostics and treatments based on the unique characteristics of each patient's cancer.\n\nOne promising target for these new approaches is a receptor called CXCR4. CXCR4 is found on the surface of many cells and is involved in various processes in the body. It is often overexpressed in different types of cancer, including breast cancer. Research has shown that CXCR4 levels are higher in metastatic sites (where cancer has spread) compared to primary tumors. CXCR4 is not only present in cancer cells but also in immune cells within the tumor environment.\n\nIn invasive breast cancer, CXCR4 plays a crucial role in tumor migration, invasiveness, metastasis, and proliferation. A clinical study evaluated 18 breast cancer patients using a new imaging method called \\[68Ga\\]Ga-PentixaFor PET\u002FCT or PET\u002FMR. They found that this method showed higher uptake in breast cancer cases with poorer prognosis compared to the traditional \\[18F\\]FDG PET\u002FCT. Higher CXCR4 expression is particularly seen in TNBC compared to other breast cancer subtypes.\n\nThe goal of the study is to assess how \\[68Ga\\]Ga-PentixaFor is distributed in the body using PET\u002FCT imaging. This will help demonstrate the potential of CXCR4 as a promising target for new treatments. If successful, \\[68Ga\\]Ga-PentixaFor PET\u002FCT could become a valuable tool for identifying patients who might benefit from treatments using \\[177Lu\\]\u002F\\[90Y\\] PentixaTher.",[299],"Metastatic Breast Cancer",[299,301,302,303,304],"Triple negative breast cancer","[68Ga]Ga-PentixaFor PET\u002FCT","[18F]FDG PET\u002FCT","CXCR4","2026-01-08",{"date":307,"type":39},"2026-01-12",{"date":309,"type":39},"2025-12-05",{"date":311,"type":20},"2030-06",{"name":45,"class":46},{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":21,"phases":322,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":217},"100434963","clinico-biological-data-collection-study-of-metastatic-lung-cancer-100434963","NCT04944030","Clinico-biological Data Collection Study of Metastatic Lung Cancer","Prediction in Silico of Therapeutic Response in a Prospective Cohort Study of Metastatic Lung Cancer Patients","EPICURE_LUNG","Inclusion Criteria:\n\n* Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample and questionnaires\n* 18 years old at time of written consent\n* Patient with histologically confirmed lung cancer\n* Lung cancer metastatic disease or locally advanced not eligible for local curative treatment intent\n* Performance status ≤ 2 (according to WHO criteria)\n* Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and \u002F or international recommendations.\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Patient must be affiliated to a Social Health Insurance\n\nExclusion Criteria:\n\n* Other malignancy treated within the last 3 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)\n* Other neuroendocrine tumour than small cell or large cell carcinoma.\n* Pregnant or nursing patient\n* Individual deprived of liberty or placed under the authority of a tutor\n* Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons",{"count":273,"type":20},[23],"RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment.\n\nPURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and biopathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.",[325],"Lung Cancer",[327,328,205,329],"Lung cancer","Prospective clinico-biological database","Prediction in silico","2025-12-01",{"date":332,"type":39},"2025-12-08",{"date":334,"type":39},"2023-04-24",{"date":336,"type":20},"2031-10",{"name":45,"class":46},{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":21,"phases":348,"briefSummary":349,"conditions":350,"keywords":353,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":366},"100552313","phase-3-corticodependent-or-corticoresistant-brain-radionecrosis-after-radiotherapy-for-brain-metastases-100552313","NCT06471465","Corticodependent or Corticoresistant Brain Radionecrosis After Radiotherapy for Brain Metastases","Corticodependent or Corticoresistant Brain Radionecrosis After Radiotherapy for Brain Metastases: a Multicentre Randomized, Controlled Double-blind Phase III Study, Comparing Bevacizumab Versus Placebo","BRADI","Inclusion Criteria:\n\n* Patient with a diagnosis of radionecrosis based on a clinical onset of symptoms and radiological findings of RN following radiotherapy, with or without pathological confirmation:\n\nMRI evidence to support the diagnosis of RN (transient increase in irradiated lesion volume -FLAIR hypersignal and\u002For enhanced portion- without rCBV increase) COMBINED with nuclear medicine imaging:\n\nbiphasic 18FDG-PET-TDM\u002FMRI according to Horky or 18F-FDOPA with stage 0-1 according to Lizarraga;\n\n* Symptoms are persistent or worsening despite administration of corticosteroids: at least 1 mg\u002Fkg\u002Fd of prednisolone or equivalent:\n\nCorticoresistant: neurological symptoms despite administration of at least 2 weeks of 1 mg\u002Fkg\u002Fd prednisolone or equivalent; Corticodependant: worsening of neurological signs or symptoms after an initial improvement when weaning off steroids at a dose \\\u003C 0.5 mg\u002Fkg\u002Fd prednisolone or equivalent;\n\n* Patients must have received the last cranial irradiation with photons or proton therapy for brain metastases ≥ 3 months with one or more sequences;\n* Age≥18-year-old;\n* ECOG performance status score ≤ 3\n* Life expectancy of at least 3 months assessed by graded prognostic score (DS-GPA) score 0.5 or greater;\n* Patient who has never received Bevacizumab for the indication of radionecrosis.\n* Adequate organ function:\n\nBone marrow function\n\n* Absolute Neutrophil Count (ANC) ≥ 1,500\u002Fmm3 Platelet Count ≥ 100,000\u002Fmm3, Haemoglobin ≥ 10 g\u002FdL (allowing transfusion or other intervention to achieve this minimum haemoglobin) Coagulation\n* International normalized ratio (INR) or prothrombin time \\\u003C 1.5 × ULN Renal function\n* No proteinuria with urine dipstick for proteinuria \\> 2+\n* Serum creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL\u002Fmin (measured or calculated using the CDK-EPI formula) Hepatic Function\n* Total bilirubin ≤1.5 x the upper limit of normal (ULN)\n* Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤3 x ULN\n\n  * Women of childbearing potential must use effective contraceptive measures during the treatment and for 6 months following its cessation;\n  * Signed informed consent;\n  * Patient affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* Evidence of active bleeding or a pathological condition at high risk of bleeding: CNS hemorrhage, bleeding diathesis or coagulopathy, hemoptysis (\\>2.5ml of bright red blood per episode), evidence of history of bowel obstruction, abdominal fistula, or gastrointestinal tract perforation or gastro intestinal abscess occurring less than 28 days prior study entry;\n* Grade 4 venous thromboelism and peripheral arterial thrombus\n* Evidence of very high intracranial pressure that suggests brain hernia and needs emergency surgery;\n* Major surgical procedure or significant traumatic injury less than 28 days prior study entry; minor surgery within 3 days prior to initiation of study treatment;\n* Clinically significant cardiovascular disease such as uncontrolled arterial hypertension (BP ≥160 mm Hg or diastolic BP ≥100 mm Hg despite maximal medical therapy), cerebrovascular event, myocardial infarction, cardiac arrhythmias, unstable angina, or congestive heart failure within the last 6 months;\n* History of hypertensive crisis or hypertensive encephalopathy\n* Patients scheduled to undergo head and neck, thoracic, or abdominal radiotherapy during the study treatment\n* Prior bevacizumab ≤ 3 months before randomization;\n* Progressive brain metastases;\n* History of severe allergic anaphylactic reactions to bevacizumab\n* Patients with a known hypersensitivity to the active substance or to any of the excipients of bevacizumab are not eligible for participation;\n* Patients with a contraindication to the treatment with bevacizumab according to the European SmPC\n* Patient pregnant and\u002For nursing;\n* Mental impairment (psychiatric illness\u002Fsocial situations) that may compromise the ability of the patient to give informed consent and comply with the requirements of the study;\n* Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship;\n* New cerebral metastasis detected during the inclusion imaging evaluation;\n* Prior diagnosis of Posterior Reversible Encephalopathy Syndrome (PRES) with bevacizumab;\n* Hypersensitivity known to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.",{"count":347,"type":20},84,[229],"Brain metastases (BM) afflict a significant portion of cancer patients, ranging from 10% to 50%, leading to debilitating symptoms and diminished quality of life, thereby impacting overall survival. Treatment options typically include surgery, stereotactic radiosurgery (SRS), and whole brain radiotherapy (WBRT). SRS has emerged as the preferred focal treatment due to its efficacy, delivering ablative doses with notable overall survival benefits, especially for single BM or postoperative cases, while being less invasive than neurosurgery and capable of addressing inoperable sites and multiple lesions. Contrastingly, WBRT is now reserved for select cases with multiple BMs ineligible for SRS, owing to its lower rate of neurocognitive toxicities and high local control rates at one year.\n\nDespite its advantages, SRS can engender late side effects, with cerebral radio necrosis (RN) being the most common, occurring in approximately 10% of patients treated. The exact pathophysiology of RN remains unclear but is thought to involve vascular injury, immune-mediated mechanisms, and direct neuronal effects, culminating in radiological changes or symptomatic manifestations necessitating treatment. Corticosteroids are the mainstay therapy, albeit with associated side effects and instances of cortico-resistance or cortico-dependence. Bevacizumab, an anti-VEGF agent, has shown promise in small studies but awaits validation in larger trials.\n\nConsequently, a randomized phase III trial seeks to evaluate the efficacy of adding bevacizumab to standard corticosteroid therapy in patients with symptomatic RN. The trial aims to determine if this combination therapy yields superior symptomatic improvement compared to corticosteroids alone. RN will be diagnosed using multimodal imaging, and the primary objective is to assess the efficacy of bevacizumab in reducing corticosteroid usage and neurological symptoms associated with RN at three months. Secondary endpoints include toxicities, quality of life, imaging changes, and response duration. Additionally, an ancillary study will explore correlations between initial imaging parameters and treatment response, as well as changes in biological parameters with bevacizumab therapy.",[351,352],"Radionecrosis of Brain","Brain Metastases",[354,355,356,357],"radionecrosis of brain","brain metastasis","quality of life","bevacizumab","2025-08-13",{"date":360,"type":39},"2025-08-17",{"date":362,"type":39},"2025-04-29",{"date":364,"type":20},"2030-08",{"name":45,"class":46},10,{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":374,"targetDuration":375,"studyType":148,"phases":4,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":388},"100387182","op2c--prialt-observatory-in-clinical-practice-100387182","NCT04321408","OP2C : Prialt® Observatory in Clinical Practice","OP2C","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Severe refractory chronic pain requiring intrathecal analgesia\n* Candidate for intrathecal analgesia treatment with ziconotide\n* Patient informed about the study and agreeing to take part in.\n\nExclusion Criteria:\n\n* Contraindications to ziconotide",{"count":199,"type":20},"4 Years","Ziconotide is a strong analgesic marketed since 2005 in Europe and reserved for the intrathecal route. Its efficacy has been proven in particular by 3 randomized clinical studies.\n\nIt is particularly effective on neuropathic pain and its main advantages are its power of action, the absence of bone marrow toxicity, and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug, or of tachyphylaxis.\n\nHowever, during these studies many adverse reactions were highlighted, especially neuropsychiatric which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment (too fast titration).\n\nIn recent years, the use of intrathecal ziconotide has become a pertinent option. Indeed, it is recommended as first-line among the intrathecal treatment options.\n\nHowever, there is a lack of data on the current use of ziconotide in current practice.\n\nThe objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide.",[378],"Refractory Pain",[380,381],"Intrathecal analgesia","Ziconotide",{"date":360,"type":39},{"date":384,"type":39},"2020-07-10",{"date":386,"type":20},"2027-09",{"name":45,"class":46},17,{"id":390,"slug":391,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":144,"minAge":17,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":21,"phases":399,"briefSummary":400,"conditions":401,"keywords":403,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":75},"100577645","to-assess-the-contribution-of-sophrology-assisted-by-an-ambulatory-device-on-the-anxiety-of-patients-undergoing-chemotherapy-for-the-treatment-of-localized-breast-cancer-100577645","NCT06800989","To Assess the Contribution of Sophrology Assisted by an Ambulatory Device on the Anxiety of Patients Undergoing Chemotherapy for the Treatment of Localized Breast Cancer","To Assess the Contribution of Sophrology Assisted by an Ambulatory Device on the Anxiety of Patients Undergoing Chemotherapy for the Treatment of Localized Breast Cancer.","DOMI-SOPHRO","Inclusion Criteria:\n\n1. Patient with localized breast cancer\n2. Patient \\> 18 years old\n3. Patient requiring chemotherapy +\u002F- combined with immunotherapy or targeted therapy, in neoadjuvant or adjuvant seeting defined by the multidisciplinary consultation meeting.\n4. Patient with signed consent\n5. Patient has national health insurance coverage\n\nExclusion Criteria:\n\n1. Patient previously treated with chemotherapy for breast cancer\n2. Patient with metastatic breast cancer\n3. History of psychiatric illness or treatment with neuroleptics, antidepressants or thymoregulators thymoregulator, prior to discovery of cancer (except resolved depressive episode, without psychiatric treatment for at least 2 years). An anxiolytic or hypnotic treatment prescribed after diagnosis is authorized\n4. Patient suffering from psychiatric disorders, delusional phases, schizophrenia contraindicating practice of sophrology\n5. Patient who has already had an introduction to sophrology in the context of her pathology, or who plans to start sophrology within within 3 months of the start of treatment outside the hospital structure and by her own means\n6. Patient does not understand or speak French\n7. Cognitive impairment or inability to understand, compromising participation in the study and use and understanding of the device\n8. Patient under legal protection, guardianship or trusteeship\n9. Inability to undergo protocol monitoring for geographical or social reasons.\n10. Patient participating in another interventional study evaluating supportive care",{"count":398,"type":20},63,[23],"Patients with localized breast cancer undergo treatment that includes breast surgery, which always alters their body image, complemented by optional additional treatments depending on the specifics and severity of their disease. These treatments are multimodal and may include chemotherapy, radiotherapy, targeted anticancer treatments, and hormone therapy, followed by prolonged monitoring for at least 5 years.\n\nA recent study showed that the announcement of cancer and its treatments is a source of reactive anxiety for 47% of patients at the time of diagnosis, which can be associated with depression in 59% of cases before chemotherapy. Anxiety increases with the intensity of treatments and is higher when chemotherapy is administered, especially in younger patients (under 50 years old).\n\nThe integrative multidisciplinary care available in treatment centers (psychologist, adapted physical activity, socio-aesthetician), combined with external support through associative networks (art therapy, music therapy, etc.), is crucial for improving quality of life and treatment side effects. Sophrology is one of these complementary therapies recommended by Association Francophone Des Soins Oncologiques De Support (French Association for Supportive Care in Oncology) within or outside the healthcare structure and is validated as supportive care. Its principle is to positively enhance patients' qualities and resources by altering states of consciousness, allowing individuals to find a balance between their thoughts, emotions, and behaviors. The three fundamental principles are to bring the body schema to a more lived reality, reinforce positive action, and develop objective reality. The \"mindfulness\" techniques used in sophrology include dynamic relaxation and sophronizations. Sophrology is based on the scientific principles of mindfulness meditation (developing attentional resources and body awareness by modulating brain waves).\n\nStudies have shown the benefits of mindfulness in managing stress, certain psychosomatic conditions, and chronic pain. Improvements in overall quality of life, stress symptoms, and sleep quality have been reported in the evaluation of a mindfulness meditation program for cancer patients. A trial demonstrated the beneficial effect of group mindfulness meditation on the anxiety of women who had undergone chemotherapy for breast cancer.\n\nToday, although sophrology is regularly used in medical care, no robust scientific study has evaluated its benefit in oncology. Institut National de la Santé et de la Recherche Médicale, together with Haute Autorité de la Santé, highlighted in its 2020 report on sophrology the significant need to scientifically assess the interest of sophrology in medical care.\n\nHowever, the use and accessibility of complementary therapies, including sophrology, are very unequal across France and depend on hospitals, geography, patient mobility, and sometimes the financial ability of patients to access paid complementary therapies. As a result, many anxious patients cannot access sophrology sessions at the desired time due to geographical, accessibility, human resource, and sometimes financial reasons (outside the hospital).\n\nThe Morphée® device could help reduce these disparities and accessibility issues by allowing patients to perform a sophrology session at any time and place after receiving explanations from a healthcare professional.",[402],"Breast Cancer Female",[404,405,406],"anxiety","sophrology","breast cancer","2025-06-25",{"date":409,"type":39},"2025-06-29",{"date":411,"type":39},"2025-05-15",{"date":413,"type":20},"2027-08-15",{"name":45,"class":46},{"id":416,"slug":417,"hasResults":11,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":21,"phases":425,"briefSummary":427,"conditions":428,"keywords":430,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":57},"100568424","phase-2-systemic-antitumor-treatment-with-or-without-pressurized-intraperitoneal-aerosol-chemotherapy-for-colon-peritoneal-metastases-pipox02-100568424","NCT06681038","Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy for Colon Peritoneal Metastases (PIPOX02)","Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Colon Peritoneal Metastases - a Multicentre Phase II Randomized Trial (PIPOX02)","PIPOX02","Inclusion Criteria:\n\n* ECOG performance status of 0 to 2;\n* Histopathologically confirmed colonic adenocarcinoma with synchronous or metachronous peritoneal metastasis (PM);\n* Unresectable PM defined as any of the following:\n\n  * PCI \\>15\n  * Extended small bowell involvement\n  * Poor general condition contra-indication to a major abdominal surgery (eg: a complete cytoreductive surgery), as decided by the medico-surgical team of the investigator's site specialised in peritoneal carcinomatosis in charge of the patient.\n* A surgical exploration performed less than 4 weeks before inclusion (if not, a laparoscopic exploration must be performed);\n* First line systemic chemotherapy for advanced \u002F metastatic colonic adenocarcinoma. Systemic chemotherapy in an adjuvant setting is allowed if completed more than 6 months before recurrence and without persistent oxaliplatin-induced neuropathy;\n* No extended intraperitoneal adherences defined by at least 9 out of 13 abdominal regions correctly explored during surgical exploration (laparoscopy or laparotomy;\n\nExclusion Criteria:\n\n* Other cancer treated within the last 3 years, with the exception of in situ cervical carcinoma or basocellular carcinoma;\n* Rectal cancer primary (tumor \\\u003C15 cm from the anal verge);\n* Mutational status corresponding to microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR);\n* Complete or partial bowel obstruction unresponsive to medical treatment;\n* Extraperitoneal polymetastatic diseases. (Only oligometastatic1 diseases are allowed for inclusion);\n* History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 6 months prior to enrolment;\n* Active gastrointestinal bleeding;\n* Inflammatory bowel disease;\n* Peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0, grade ≥2",{"count":424,"type":20},114,[426],"PHASE2","The goal of this clinical trial is to learn if Pressurized intraperitoneal aerosol chemotherapy (PIPAC) significantly improve the progression-free survival (PFS) in patients with advanced peritoneal metastasis from colorectal cancer.\n\nResearchers will compare 2 strategies, systemic treatments (chemotherapy + targeted therapy) corresponding to standard treatment with or without intraperitoneal oxaliplatin (PIPAC) to see if PIPAC improve the progression-free survival.\n\nParticipants will:\n\n* receive a standard treatment every 2 weeks for 12 cycles of intravenous FOLFIRI or FOLFIRINOX + targeted systemic therapy (anti-EGFR or anti-VEGF) in the both arms.\n* receive up to a maximum of 4 PIPAC every 6 weeks with pressurized aerosol containing oxaliplatin in experimental arm.\n* receive a maintenance treatment until progression or until the onset of severe toxicity after 12 cycles.\n* be asked to perform a CT scan and carcinoembryonic antigen (CEA) assay every 8 weeks until progression",[429],"Peritoneal Metastases from Colorectal Cancer",[431,432,433,434],"Surgical oncology","Peritoneal metastasis","Pressurized IntraPeritoneal Aerosol Chemotherapy","Systemic chemotherapy","2024-11-07",{"date":437,"type":39},"2024-11-08",{"date":439,"type":20},"2025-02",{"date":441,"type":20},"2029-08",{"name":45,"class":46},{"id":444,"slug":445,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":21,"phases":452,"briefSummary":453,"conditions":454,"keywords":457,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":469},"100496945","assessment-and-prevention-of-caregiver-burden-in-oncology-100496945","NCT05750836","Assessment and Prevention of Caregiver Burden in Oncology","PREPAC-01","Inclusion Criteria:\n\n* Caregiver designated by the patient;\n* Caregiver of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month;\n* Caregiver of patient already cared for by a nurse before inclusion or going to start a nursing follow-up;\n* Caregiver of a patient with a score ≥2 of social fragility and\u002For psychological fragility and\u002For nutritional fragility and\u002For complexity;\n\nExclusion Criteria:\n\n* Patient whose life expectancy is assumed to be \\\u003C 6 months;\n* Patient living in an institution (EHPAD, MAS, SSR, MCO, USLD) at inclusion;\n* Caregiver declared as having a pathology that could alter his\u002Fher capacity to support (psychiatric history, dementia…) or under guardianship.",{"count":451,"type":20},250,[23],"The goal of this randomized, open and controlled supportive care study is to see if we can reduce the burden on the caregiver by offering the caregiver systematic and regular support from the nurse (APN, nurse coordinator in French health care organisations) compared to a support focused on the patient. At the same time, we will also evaluate the impact of this personalised support for the caregiver on their anxiety and quality of life.\n\nParticipants will caregivers of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month.\n\nResearchers will compare 2 groups : a group where caregivers benefit from specific nursing support and a group of caregivers with no specific nursing support.\n\nThe specific support includes 3 mandatory on-site nursing consultations with the patient's caregiver and interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.",[455,456],"Oncology","Caregiver Burden",[458,459,460,456],"Nurse","Supportive Care","Zarit scale","2023-06-26",{"date":463,"type":39},"2023-06-28",{"date":465,"type":20},"2023-07",{"date":467,"type":20},"2027-06",{"name":45,"class":46},5,{"id":471,"slug":472,"hasResults":11,"nctId":473,"briefTitle":474,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":144,"minAge":477,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":21,"phases":480,"briefSummary":481,"conditions":482,"keywords":486,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":500},"100413697","phase-2-impact-of-neoadjuvant-hormonal-therapy-on-the-surgical-management-of-extensive-ductal-carcinomas-in-situ-100413697","NCT04666961","Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ","HORNEO01","Inclusion Criteria:\n\n1. Patient ≥ 40 years old\n2. Histological diagnosis of ductal carcinoma in situ without infiltrating contingent\n3. Clinical T0N0\n4. Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status\n5. Indication for mastectomy\n6. DCIS visible on MRI performed with clip sequence\n7. Effective contraceptive method for women of childbearing age who are sexually active and who have reported sexual activity.\n8. Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator.\n9. Affiliated patient or beneficiary of the social security system.\n\nExclusion Criteria:\n\n1. Invasive breast carcinoma\n2. Lobular carcinoma in situ\n3. pN+ patient\n4. Indication for conservative surgery\n5. Contraindications to anastrozole or tamoxifen\n6. Concomitant treatments that may interact and reduce the efficacy of tamoxifen by interaction with cytochrome CYP2D6.\n7. Histologically proven multifocal lesion\n8. Contraindication to breast MRI (pace maker, heart valve, metallic implant, neuronal or peripheral stimulator, severe claustrophobia, ...)\n9. History of homolateral breast cancer\n10. Ongoing contralateral breast cancer\n11. Known mutation BRCA1 BRCA2\n12. Other cancer in progress at inclusion\n13. Pregnant woman, or breastfeeding,\n14. Persons deprived of liberty or under guardianship or trusteeship,\n15. Impossibility to undergo the medical follow-up of the trial for geographical, social, psychic or psychiatric reasons.","40 Years",{"count":479,"type":20},262,[426],"Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of the lesions, which most often manifest as diffuse microcalcifications.\n\nThis mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients.\n\nNeoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy.\n\nAdjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence.\n\nThe HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ. The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS.",[483,484,485],"Ductal Carcinoma in Situ","Extensive Disease","Mastectomy",[487,488,489,490,182,491],"Neoadjuvant hormonotherapy","Tamoxifen","Anastrozole","conservative surgery","extensive microcalcifications","2022-04-21",{"date":494,"type":39},"2022-04-22",{"date":496,"type":39},"2021-02-03",{"date":498,"type":20},"2033-08-01",{"name":45,"class":46},8,""]