[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"soft-tissue-sarcoma-excluding-gist\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:soft-tissue-sarcoma-excluding-gist":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100631983","phase-2-assessment-of-the-long-term-efficacy-of-moderately-hypofractionated-neoadjuvant-radiotherapy-soft-tissue-sarcoma-in-the-limbs-or-trunk-wall-100631983",false,"NCT07507773","Assessment of the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall","Phase II Clinical Trial Assessing the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall, Incorporating Translationnal Research","NEORASARC","Inclusion Criteria:\n\n* Patient aged ≥ 18 years ;\n* Localised sarcoma of a limb, the root of a limb, or the trunk wall ;\n* Histologically confirmed diagnosis of soft tissue sarcoma regardless of the grade ;\n* Diagnosis biopsy performed at Centre Oscar Lambret, with specimen available for translational research ;\n* Indication of neoadjuvant radiotherapy according to the multidisciplinary consultation meeting ;\n* Tumor considered operable with a curative intent and conservative intent according to the multidisciplinary consultation meeting ;\n* Affiliation to the French National Social Security System ;\n* Informed and signed consent\n\nExclusion Criteria:\n\n* Metastatic disease (including local lymph node diffusion) ;\n* Visceral or retroperitoneal sarcoma ;\n* Tumor considered inoperable even after radiotherapy, according to the multidisciplinary consultation meeting ;\n* Indication of neoadjuvant or adjuvant chemotherapy ;\n* Ewing tumor of soft tissue, desmoid tumor, embryonal or alveolar rhabdomyosarcoma ;\n* Pregnant or breastfeeding women ;\n* Patients under protective measures ;\n* Patient refusal.","ALL","18 Years",{"count":20,"type":21},135,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This trial aims to assess the long-term efficacy of moderately hypofractionated neoadjuvant radiotherapy for soft tissue sarcoma in the limbs or trunk wall. The primary outcome is local disease control, assessed by the cumulative incidence of progression\u002Frecurrence.\n\nAfter informed consent has been obtained and eligibility criteria have been checked, a baseline assessment will be performed followed by the experimental treatment: intensity-modulated radiotherapy with a moderately hypofractionated regimen consisting in 15 fractions of 2.7 Gy administered over 3 weeks.\n\na follow-up assessment will be performed 3 to 4 weeks after the last radiotherapy session.\n\nTumor resection will be performed 4 to 8 weeks after the radiotherapy. Patients will then be followed up until the end of the study; planned 5 years after the last inclusion.\n\nRadiotherapy will be evaluated in terms of safety and efficacy.",[27,28,29,30],"Soft Tissue Sarcoma Adult","Soft Tissue Sarcoma (Excluding GIST)","Soft Tissue Sarcoma of the Trunk and Extremities","Soft Tissue Sarcoma of the Limb",[32,33,34,35,36],"Sarcoma","Trunk","Limb","Radiotherapy","Neoadjuvant","RECRUITING","2026-06-18",{"date":40,"type":41},"2026-06-22","ACTUAL",{"date":43,"type":21},"2026-06-01",{"date":45,"type":21},"2035-06-01",{"name":47,"class":48},"Centre Oscar Lambret","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":49},"100628141","phase-2-liposomal-irinotecan-in-combination-with-temozolomide-and-bevacizumab-in-patients-with-advanced-sts-100628141","NCT07457775","Liposomal Irinotecan in Combination With Temozolomide and Bevacizumab in Patients With Advanced STS","A Study of Liposomal Irinotecan in Combination With Temozolomide and Bevacizumab in Patients With Relapsed or Refractory Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Age ≥14 years old, gender not limited;\n2. For metastatic or surgically unresectable recurrent and refractory soft tissue sarcomas confirmed by histological evidence, this combination therapy regimen can be used as determined by the researcher.\n3. Disease progression or intolerable toxicity has occurred after at least one line of systemic therapy (with or without targeted therapy) in the past.\n4. At least one measurable lesion (RECIST v1.1);\n5. ECOG: 0-2;\n6. Expected survival period ≥3 months;\n7. Good function of major organs, that is, meeting the following criteria (without receiving any blood components or cell growth factors within 14 days prior to randomization) :\n\nNeutrophils ≥1.5\\*109\u002FL; Platelet count ≥80\\*109\u002FL; Hemoglobin ≥9g\u002Fdl; Serum albumin ≥3g\u002Fdl; (2) Total bilirubin ≤ 1.5 times the upper limit of the normal value (biliary drainage is allowed for biliary obstruction); ALT and AST≤ 3 times the upper limit of the normal value (for patients with liver metastasis, it can be relaxed to ≤ 5 times the upper limit of the normal value).\n\n(3) Serum creatinine ≤ 1.5 times the upper limit of the normal value, creatinine clearance rate ≥60ml\u002Fmin; (4) INR≤ 1.5 times the upper limit of the normal value and APTT≤ 1.5 times the upper limit of the normal value (screening can be conducted for anticoagulant therapy with stable doses such as low-molecular-weight heparin or warfarin and INR within the expected therapeutic range of the anticoagulant); (5) Electrocardiogram: QTcF≤450ms(for males), ≤470ms(for females); (6) Cardiac color Doppler ultrasound: LVEF (left ventricular ejection fraction) ≥50%; Women of childbearing age must undergo a blood pregnancy test within 3 days before randomization, and the result must be negative. They must also be willing to take appropriate contraceptive measures during the trial and for 6 months after the end of treatment. For men, it should be agreed to use appropriate methods of contraception during the study period and within 3 months after the end of treatment; 9. The subjects voluntarily joined this study and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with known central nervous system metastases;\n2. Severe gastrointestinal dysfunction (with bleeding, obstruction; inflammation above grade 2; diarrhea above grade 1);\n3. Patients who have a history of treatment with irinotecan, temozolomide, bevacizumab or similar drugs;\n4. Within the two weeks prior to randomization, there was third space effusion (such as a large amount of pleural effusion) that could not reach a stable state except for ascites (no intervention treatment is required after the drainage tube is removed);\n5. Patients with ascites with clinical symptoms who require puncture or drainage, or those who have received ascites drainage within the past 3 months (except for those with only a small amount of ascites shown on imaging and controllable, but without clinical symptoms);\n6. Currently accompanied by interstitial pneumonia or interstitial lung disease, or those with a history of interstitial pneumonia or interstitial lung disease requiring hormone therapy in the past, or other conditions that may interfere with the judgment and management of immune-related lung toxicity such as pulmonary fibrosis or organizing pneumonia (for example, Subjects with obliterative bronchiolitis, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or those with active pneumonia or severely impaired lung function as shown by chest CT during the screening period; Active tuberculosis\n7. Subjects with active autoimmune diseases or a history of autoimmune diseases that may relapse \\[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (subjects that can be controlled only through hormone replacement therapy can be enrolled)\\]; Those with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type 1 diabetes treated with insulin, or childhood asthma that has been completely relieved and does not require any intervention in adulthood can be enrolled.\n8. Known peripheral neuropathy (CTCAE≥ grade 3);\n9. Known dihydropyrimidine dehydrogenase (low activity) or deficiency;\n10. Severe infections (CTCAE \\> grade 2) occurred within 4 weeks prior to randomization, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc. There were symptoms and signs of infection within 2 weeks prior to randomization, requiring intravenous antibiotic treatment (except for prophylactic antibiotic use).\n11. Have received any of the following treatments:\n\n    The concomitant medication contained CYP3A4, CYP2C8 strong suppressor\u002Fstrong inducer or UGT1A1 strong suppressor within 2 weeks prior to randomization; Use immunosuppressants or systemic hormones for immunosuppressive purposes within 2 weeks before randomization (dose \\>10mg\u002F day, prednisone or other equivalent therapeutic hormones); \\\u003Cs:1\\> Received radiotherapy within 2 weeks prior to randomization; Undergo major surgeries (such as thoracotomy, laparotomy, etc.) within 4 weeks before randomization; The patient has received any other clinical study drug treatment within 4 weeks prior to randomization, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study.\n12. Abnormal coagulation function, with a bleeding tendency, or currently undergoing thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (≤100mg\u002F day) and low-molecular-weight heparin (enoxaparin 40mg\u002F day and other low-molecular-weight heparin at equivalent doses) is permitted.\n13. There are poorly controlled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Has suffered a myocardial infarction within six months; (4) Patients with clinically significant supraventricular or ventricular arrhythmias who require treatment or intervention;\n14. Within the 3 years prior to randomization, the patient had a malignant tumor other than relapsed or refractory soft tissue sarcoma, excluding well-treated carcinoma in situ, cutaneous basal cell or squamous cell carcinoma, etc., which showed no signs of recurrence.\n15. Individuals who are known to be allergic to irinotecan liposomes, other liposome products, temozolomide, bevacizumab, or any of the components in the above products;\n16. Those who are known to have acquired immune deficiency syndrome (AIDS) or test positive for HIV, or are active syphilis carriers;\n17. There is a clear history of neurological or mental disorders in the past, including epilepsy or dementia;\n18. As determined by the researchers, the subjects have other factors that may force them to terminate the study halfway, such as non-compliance with the protocol, suffering from other serious diseases (including mental disorders) that require concurrent treatment, having severely abnormal laboratory test values of clinical significance, family or social factors that may affect the safety of the subjects or the collection of trial data, etc.","14 Years",{"count":59,"type":21},24,[24],"The study is expected to include 24 patients with metastatic or surgically unresectable relapsed\u002Frefractory soft tissue sarcoma confirmed by histological evidence, who have received at least one line of systemic treatment previously. The efficacy and safety of liposome irinotecan combined with temozolomide and bevacizumab in the treatment of relapsed\u002Frefractory soft tissue sarcoma will be evaluated.",[28],"NOT_YET_RECRUITING","2026-03-04",{"date":66,"type":41},"2026-03-09",{"date":68,"type":21},"2026-03-31",{"date":70,"type":21},"2028-01-31",{"name":72,"class":48},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":92,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100605961","phase-2-hypofractionated-3-week-preoperative-proton-or-x-ray-radiotherapy-for-patients-with-localized-soft-tissue-sarcoma-100605961","NCT07169344","Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma","PROSARC-1. Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.","PROSARC-1","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of informed consent.\n2. Histological diagnosis of STS, except rhabdomyosarcoma and Ewing sarcoma. Pleomorphic rhabdomyosarcomas are eligible.\n3. Primary tumor localized in head, neck, extremity, girdle and\u002For trunk wall.\n4. Measurable disease according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n6. Before patient registration, written informed consent must be given according to national and local regulations.\n7. Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for PBT.\n\nExclusion Criteria:\n\n1. Locoregional or distant metastasis as assessed by CT and\u002For MRI at time of diagnosis. Patients with lung nodules \\\u003C10 mm of uncertain etiology may be included.\n2. Prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may be included. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may be included.\n3. Previous radiotherapy to the primary tumor region.\n4. Patients with pacemakers and\u002For implanted defibrillators.\n5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.\n6. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.",{"count":82,"type":21},110,[24],"The purpose of the study is to investigate whether a personalized selection of patients with localized soft tissue sarcoma for preoperative proton radiation therapy can reduce long-term radiation side effects without increasing surgical complications or reducing the effectiveness of the treatment. Two radiation plans will be created for each patient-one for protons and one for photons-and through a national meeting, we will determine which type of radiation therapy each patient will receive. The radiation dose will be the same for both photons and protons.\n\nThe primary endpoint is surgical complications 120 days after surgery. Secondary endpoints include overall survival, local recurrence-free survival, disease-free survival, side effects, and quality of life. Furthermore, the study will investigate biomarkers that may predict response to radiation therapy, including changes in the tumor's genetic material (DNA), measurement of various molecules in the bloodstream, and the tumor's appearance on MRI scans.\n\nThe study will be conducted in Norway, with a planned inclusion of 110 patients.",[28,27,29,86,87,88,89,90,91],"Synovial Sarcomas","Leiomyosarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Myxofibrosarcoma (MFS)","Liposarcoma","Pleomorphic Rhabdomyosarcoma",[93,94,95,96],"Soft tissue sarcoma","proton radiotherapy","x-ray radiotherapy","surgical complications","2026-01-26",{"date":99,"type":41},"2026-01-28",{"date":97,"type":41},{"date":102,"type":21},"2035-11-01",{"name":104,"class":48},"Oslo University Hospital",4]