[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"soft-tissue-sarcoma-of-the-trunk-and-extremities\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:soft-tissue-sarcoma-of-the-trunk-and-extremities":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,80,108,141,173,195,217],{"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},"100603259","fluorescence-guided-optimization-of-sarcoma-margins-100603259",false,"NCT07134192","Fluorescence-Guided Optimization of Sarcoma Margins","FOCUS","Inclusion Criteria:\n\n* Biopsy verified intermediate-to-high grade sarcoma of theextremity or trunk wall\n* Age\\>18 years old\n* Tumor operable\n* Curative intent at time of surgery\n* Consent of patient\n\nExclusion Criteria:\n\n* History of allergic reaction to iodine-containing pharmaceuticals\n* End-stage renal disease or eGFR \\\u003C15\n* Patient decision\n* Lack of capacity\n* Inoperability","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection.",[26,27],"Soft Tissue Sarcoma of the Trunk and Extremities","Sarcoma",[27,29,30,31,32,33,34],"ICG","Indocyanine green","Fluorescence Guided Surgery","FGS","STS","Soft Tissue Sarcoma","RECRUITING","2026-06-29",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2025-09-01",{"date":43,"type":20},"2028-03-01",{"name":45,"class":46},"University of Aarhus","OTHER",2,{"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":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100631983","phase-2-assessment-of-the-long-term-efficacy-of-moderately-hypofractionated-neoadjuvant-radiotherapy-soft-tissue-sarcoma-in-the-limbs-or-trunk-wall-100631983","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.",{"count":57,"type":20},135,[59],"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.",[62,63,26,64],"Soft Tissue Sarcoma Adult","Soft Tissue Sarcoma (Excluding GIST)","Soft Tissue Sarcoma of the Limb",[27,66,67,68,69],"Trunk","Limb","Radiotherapy","Neoadjuvant","2026-06-18",{"date":72,"type":39},"2026-06-22",{"date":74,"type":20},"2026-06-01",{"date":76,"type":20},"2035-06-01",{"name":78,"class":46},"Centre Oscar Lambret",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100639015","phase-3-testing-short-course-radiation-versus-standard-course-radiation-for-soft-tissue-sarcomas-that-need-surgery-and-radiation-100639015","NCT07615049","Testing Short-Course Radiation Versus Standard-Course Radiation for Soft Tissue Sarcomas That Need Surgery and Radiation","Phase III Randomized Study Testing Non-Inferiority of Short-Course Ultra-Hypofractionated Radiation (UHRT-5) Versus Standard Fractionation (RT-25) for Stage II-IIIB, Extremity, Resectable Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Participants must have histological evidence of a soft tissue sarcoma from core or incisional biopsy. Participants must have a primary or locally recurrent tumor. Stage II-IIIB (by American Joint Committee on Cancer \\[AJCC\\] 8th edition) soft tissue sarcoma is required\n\n  * Prior partial excision or partial excisional biopsy of the tumor, with imaging evidence of gross residual disease \\> 1cm in longest dimension (stage II-IIIB)\n* Participants must have a primary site of disease in the extremity, including the shoulder girdle and hip girdle but excluding the hands and feet\n\n  * Participants with primary sites of trunk, head, neck, or intra-abdominal, intrapelvic, or retroperitoneal region are not eligible\n  * Participants with extension of the primary tumor into adjacent regions (e.g. torso, hands, feet) are eligible\n* Participants must have an MRI of the primary site within 90 days prior to randomization. The MRI field of view must contain the entirety of the tumor (may be accomplished with multiple MRI scans). MRI must contain axial acquired T1 weighted with fat suppression, T1 weighted sequence with gadolinium contrast with fat suppression, and T2 weighted fat suppression sequence\n* Participants must have no evidence of metastatic disease by CT imaging of the chest (or positron emission tomography \\[PET\\] CT), within 28 days before randomization\n\n  * Given the lack of specificity of chest CT, pulmonary nodule(s) ≤ 5 mm without a histological diagnosis are not exclusionary\n  * Participants with pulmonary nodule(s) measuring 6-10 mm on chest CT are eligible if the nodules appear stable compared to prior chest imaging from at least 6 months ago, or if an fludeoxyglucose F-18 (18FDG)-PET scan indicates that the nodules are unlikely to be metastatic disease\n  * Pulmonary nodules \\> 10 mm should be considered metastatic unless proven otherwise by biopsy\u002Fresection or stable appearance for at least 6 months on imaging\n* Participants must not have fungating tumor. (i.e., tumor breakthrough of skin)\n* Participants must not have myxoid liposarcoma, embryonal rhabdomyosarcoma, alveolar rhabdomyosarcoma, gastrointestinal stromal tumor, osteosarcoma, neurotrophic tyrosine receptor kinase (NTRK)-rearranged spindle cell neoplasm, desmoplastic small round cell tumor, Ewing sarcoma, or sarcoma arising from bone\n* Participants must not have known brain metastases. Brain imaging studies are not required for eligibility if the participant has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease\n* Participants must have been evaluated by a surgeon, and it must have been determined that they are a good candidate for a limb salvage resection with an expectation of negative margins, within 35 days prior to randomization. Anticipated positive margins on fixed critical structures are allowed\n* Participants must not have had prior treatment for the current tumor (systemic therapy, radiation, or complete surgical resection)\n* Participants must not have had prior radiation to the anatomical site\n* Participants must be ≥ 18 years old at the time of randomization\n* Participants must have Zubrod performance status of 0-2\n* Participants must have medical history and physical exam within 28 days prior to randomization. History and physical examination must include a description of the location of the tumor, including lateralization and extremity\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must not have uncontrolled intercurrent illnesses or any other significant condition(s) that would make this protocol unreasonably hazardous\n* Participants with a history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants registered by sites located in the United States only must be offered the opportunity to participate in specimen banking\n* NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":88,"type":20},296,[90],"PHASE3","This clinical trial compares the effect of short-course ultrahypofractionated radiation therapy over 5 days (UHRT-5) to standard-course radiation therapy over 25 days (RT-25) in treating patients with soft tissue sarcomas of the extremities that may be primary or that may have come back to nearby tissue or lymph nodes after a period of improvement (locally recurrent) and that can be removed by surgery (resectable). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. 3-dimensional (3D) conformal radiation therapy (CRT) uses a computer to create a 3D picture of the tumor. This allows doctors to give the highest possible dose of radiation to the tumor, while sparing the normal tissue as much as possible. Intensity-modulated radiation therapy (IMRT) is a type of 3D radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Standard-course (fractionated) radiation divides the total dose of radiation therapy into several smaller, equal doses delivered over a period of several days. Ultrahypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving UHRT-5 may be as effective as RT-25 in treating patients with primary or locally recurrent soft tissue sarcomas of the extremities that are resectable. It may also improve quality of life by requiring fewer treatments.",[93,94,26,95,96],"Recurrent Soft Tissue Sarcoma of the Trunk and Extremities","Resectable Soft Tissue Sarcoma of the Trunk and Extremities","Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","NOT_YET_RECRUITING","2026-05-22",{"date":100,"type":39},"2026-05-29",{"date":102,"type":20},"2026-12-02",{"date":104,"type":20},"2030-04-30",{"name":106,"class":107},"SWOG Cancer Research Network","NETWORK",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":128,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":79},"100626230","precision-medicine-approaches-for-neoadjuvant-therapy-in-high-risk-sarcoma-patients-100626230","NCT07432932","Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients","PANTHR-S","Inclusion Criteria:\n\n* Written informed consent for the prospective cohort\n\n  * Histopathological diagnosis of high-risk soft tissue sarcoma and one of the following subtypes: DDLPS, LMS, SS, vascular sarcomas or MPNST. Other subtypes may be included with PI approval.\n  * High-risk sarcoma definition:\n\n    * Greater than 5cm or Grade 3\n    * Deep anatomic location\n  * Have disease amenable to biopsy\n\n    o Patients who are not amenable to repeat biopsy at baseline can be reviewed with the local site PI for consideration of inclusion to the study\n  * Resectable tumour\n  * Measurable disease by RECIST 1.1\n  * Aged ≥ 18 years\n  * WHO performance status 0-2\n  * For patients receiving NCT, medically fit enough, with adequate organ function, to undergo neoadjuvant chemotherapy\n  * Patients medically fit enough to undergo surgical resection\n  * Capable of giving written informed consent (for prospective cohort) and comply with the study schedule\n  * Patients may also participate in the STRASS 2 trial\n\nExclusion Criteria:\n\n-Prior invasive malignancy in last 5 years, low risk malignancies in the last 5 years may be reviewed by the PI.\n\n* Known additional malignancy that is progressing or requires active treatment\n* Metastatic disease not amenable to curative intent local therapy\n* Any active uncontrolled medical conditions",{"count":116,"type":20},800,"OBSERVATIONAL","This is a cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT) in high-risk soft tissue sarcoma (STS) patients with dedifferentiated liposarcoma (DDLPS), leiomyosarcoma (LMS), synovial sarcoma (SS), vascular sarcomas, malignant peripheral nerve sheath tumour (MPNST) or other subtypes. It comprises of both retrospective and prospective tissue collection from patients advancing directly to surgery (control group) and patients receiving NCT and surgery.",[27,120,121,122,62,26,64,123,124,125,126,127],"Sarcoma, Leiomyo-, Adult","Sarcoma, Synovial, Adult","Soft Tissue Sarcoma (STS)","Retroperitoneal Sarcoma","Liposarcoma, Dedifferentiated","Liposarcoma","Leiomyosarcoma (LMS)","Angiosarcoma",[129,130,131],"PANTHRS","PANTHRS-S","Sarcoma Accelerator","2026-02-18",{"date":134,"type":39},"2026-02-25",{"date":136,"type":39},"2021-11-19",{"date":138,"type":20},"2028-06-30",{"name":140,"class":46},"Royal Marsden NHS Foundation Trust",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":152,"conditions":153,"keywords":159,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"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":150,"type":20},110,[59],"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.",[63,62,26,154,155,156,157,125,158],"Synovial Sarcomas","Leiomyosarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Myxofibrosarcoma (MFS)","Pleomorphic Rhabdomyosarcoma",[160,161,162,163],"Soft tissue sarcoma","proton radiotherapy","x-ray radiotherapy","surgical complications","2026-01-26",{"date":166,"type":39},"2026-01-28",{"date":164,"type":39},{"date":169,"type":20},"2035-11-01",{"name":171,"class":46},"Oslo University Hospital",4,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":193,"leadSponsor":194,"locationsCount":47},"100606316","phase-2-dose-escalated-hypofractionated-definitive-proton-radiotherapy-for-patients-with-inoperable-soft-tissue-sarcoma-100606316","NCT07173972","Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.","PROSARC-2. Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.","PROSARC-2","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of informed consent.\n2. Histological diagnosis of soft tissue sarcoma including gastrointestinal stromal tumor (GIST).\n3. Measurable disease according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n5. For patients with metastatic disease a life-expectancy greater than 2 years should be expected.\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 Proton Beam radiotherapy.\n\nExclusion Criteria:\n\n1. Patients with a 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.\n2. Previous radiotherapy to the tumor site.\n3. Patients with pacemakers and\u002For implanted defibrillators.\n4. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.\n5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.",{"count":182,"type":20},40,[59],"The purpose of the study is to study if dose escalated proton radiotherapy can improve local controll for patients with inoperable soft tissue sarcomas. The standard treatment is photon-based radiation. By using proton radiotherapy instead, the hypothesis is that the dose can be increased to enhance treatment effectiveness without increasing side effects.\n\nThe planned radiation dose is 56 Gy in 16 fractions (treatments) over 4 weeks (4 fractions per week), with a maximum dose escalation centrally in the tumor up to 80 Gy (5 Gy per fraction).\n\nAt the same time, the study will investigate biomarkers that can predict treatment response, including changes in the tumor's genetic material (DNA), measurements of various molecules in the bloodstream, and the tumor's appearance on MRI scans.\n\nThe primary endpoint is local control after 2 years, meaning that the treated tumor has not grown during this period. Secondary endpoints include overall survival, progression-free survival, radiological response rates, side effects, and quality of life.\n\nThe study will be conducted in Norway, with a planned inclusion of 40 patients.",[122,62,26,154,156,186,126,187,158,125],"Myxofibrosarcoma","Pleomorphic Liposarcoma",[189,161,190],"soft tissue sarcoma","inoperable soft tissue sarcoma",{"date":166,"type":39},{"date":164,"type":39},{"date":169,"type":20},{"name":171,"class":46},{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":4},"100613367","surgical-timing-after-preoperative-hypofractionated-radiotherapy-for-localized-extremity-and-trunk-soft-tissue-sarcoma-100613367","NCT07265661","Surgical Timing After Preoperative Hypofractionated Radiotherapy for Localized Extremity and Trunk Soft Tissue Sarcoma","Surgical Timing After Preoperative Hypofractionated Radiotherapy for Patients With Primary Localized Soft Tissue Sarcoma of the Extremity and Trunk: a Randomized Phase 2 Clinical Trial","STARS","Inclusion Criteria:\n\n* Voluntary written informed consent, with the ability to fully understand and effectively communicate, before performance of any study-related procedure not part of normal medical practice, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.\n* Age \\> 18 years\n* Proven diagnosis of primary, resectable extremity\u002Ftrunk wall STS with low-medium risk (Sarculator© predicted 10y-OS \\> 60%)\n* Measurable disease criteria (RECIST 1.1 and CHOI)\n* ECOG: 0, 1 or 2 (if influenced by orthopedic condition and not by general status)\n* No major contraindication to the planned radiotherapy or surgical treatment\n* Active participation with adherence to requested treatment schedule and follow-up\n* Female subject will undergo a negative pregnancy test\n* Adequate bone marrow function (hemoglobin \\> 9g\u002FdL, Leukocytes \\> 3000\u002Fmm³, platelets \\> 100,000\u002Fmm³). Patients with plasma creatinine ≤ 1.6 mg\u002FdL, transaminase (AST-SGOT, ALT-SGPT) ≤ 2.5 times the UNL; total bilirubin ≤ 1.5 time the UNL; alkaline phosphatase ≤ 2.5 times the UNL are acceptable. CRP, LDH, total protein and albumin must also be recorded.\n* HBV and HCV serologies must be performed prior to patient inclusion. If hepatitis B surface antigen (HBsAg) is positive, further evaluation is required to exclude active viral replication (i.e., testing for hepatitis B e antigen \\[HBeAg\\] and HBV DNA). If either of these markers is positive, study inclusion is not recommended. In such cases, prophylactic treatment with lamivudine may be considered at the investigator's discretion. If a potential participant tests positive for anti-HCV antibodies, active infection must be ruled out through a qualitative HCV PCR test. If PCR testing cannot be performed, or if it confirms active infection, the patient will not be eligible for the study. Patients must be HIV-seronegative, with a CD4+ T-cell count greater than 400\u002Fmm³. Individuals with clinically significant immunodeficiency-either congenital or acquired-are not eligible for enrollment\n\nExclusion Criteria:\n\n* Age \\\u003C 18y\n* Soft tissue sarcomas (STS) originating at different sites (i.e., retroperitoneal, abdominal, pelvic, head and neck), gynecological sarcomas, as well as gastrointestinal stromal tumors (GISTs), desmoid-type fibromatosis and pediatric-type sarcomas (i.e., extraosseous Ewing sarcoma, embryonal\u002Falveolar rhabdomyosarcoma, desmoplastic small round cell tumor) are excluded.\n* Recurrent or metastatic condition or previous whoop-surgery for sarcoma (incisional biopsies are allowed if performed 6 months before referral).\n* Unresectable tumors (with limb sparing surgery)\n* Diagnosed oncological condition in the 5 years before enrollment (exceptions: Gleason \\\u003C6 prostatic adenocarcinoma; In-situ cervical cancer and melanoma; basal cell skin carcinoma radically treated)\n* Prior radiation treatment to the site designated for planned surgery or radiotherapy, regardless of indication\n* Any medical condition that can impair and reduce life expectancy to less than 2 years including but not limited to significant systemic diseases grade 3 or higher on the CI-CTCAE v5.0 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity\n* Uncontrolled bacterial, fungal, or viral infections-either systemic or localized at the site of planned surgery or radiotherapy\n* Severe psychiatric disorder, psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent.\n* Patients who had participated in another clinical trial and\u002For had received any other investigational product in the last 30 days prior to inclusion\n* Patients who had received any other treatment for the disease under study including chemotherapy, radiotherapy, surgery or any other treatment with curative intent. incisional biopsies are allowed if performed 6 months before referral.\n* Inability to comply with the requested follow-up\n* Women who are pregnant or breast-feeding\n* Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study\n* BMI \\> 40 and BMI \\\u003C 18",{"count":204,"type":20},142,[23],"Phase II, national, multicentric, prospective, randomized (1:1) non-inferiority trial with two parallel groups, incorporating a concurrent observational cohort of eligible non-randomized patients, designed to address critical knowledge gaps by prospectively evaluating the safety, efficacy, and feasibility of preoperative ultra-hypofractionated radiotherapy (HFRT) in patients with soft tissue sarcomas (STS) of the extremities and trunk.",[26],"2026-01-02",{"date":210,"type":39},"2026-01-06",{"date":212,"type":20},"2026-01-30",{"date":214,"type":20},"2035-12-01",{"name":216,"class":107},"Italian Sarcoma Group",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":224,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":4},"100556576","evaluation-of-chest-ct-versus-chest-x-ray-for-lung-surveillance-after-curative-intent-resection-of-high-risk-truncal-extremity-soft-tissue-sarcoma-100556576","NCT06526897","Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","A Phase III Randomized Controlled Trial of Chest CT vs Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Patient must be ≥ 1 and ≤ 85 years old on the day of randomization\n* Patient must have and undergone curative-intent (R0 or R1) resection of an American Joint Committee on Cancer (AJCC) 8th edition stage III truncal or extremity soft tissue sarcoma\n* Patient must have a high-risk (grade 2 or 3) soft tissue carcinoma according to the French Federation of Cancer Centers Sarcoma Group (FNCLCC)\n\n  * Patients with the following histiotypes are eligible: dedifferentiated liposarcoma, pleomorphic liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, myxofibrosarcoma, fibrosarcomatous dermatofibrosarcoma protuberant variant, spindle cell sarcomas, pleomorphic sarcoma, fibrosarcoma,extra-skeletal myxoid chrondrosarcoma, extraskeletal Ewing and Ewing-like sarcoma, sarcoma not otherwise specified (NOS), or other grade 2 or grade 3 sarcomas not further classified\n  * Patients with a high-risk histiotype that is typically not graded, including adult pleomorphic rhabdomyosarcoma, synovial sarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma, epithelioid sarcoma, or clear cell sarcoma are eligible\n* Patient must have a tumor size ≥ 5 cm\n* Patient must have had a R0 or R1 oncologic resection on final pathologic report\n* Patient must have a baseline chest CT obtained within 30 days prior to randomization that is negative or detecting only non-suspicious nodules ≤ 4 mm\n* Patients receiving preoperative or post-operative chemotherapy and\u002For radiotherapy for the primary tumor are eligible. However, all chemotherapy and\u002For radiotherapy must be completed prior to randomization\n* Patient must not be pregnant due to the potential harmful risks associated with CXR and CT imaging to the unborn fetus\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not have a chest wall\u002Fupper truncal primary tumor requiring locoregional surveillance with CT or magnetic resonance imaging (MRI)\n* Patient must not have retroperitoneal, mesenteric\u002Fabdominal sarcoma\n* Patient must not have a primary bone sarcoma (including osteosarcomas, Ewings sarcoma, or chondrosarcomas), desmoid tumor, gastrointestinal stromal tumor (GIST), Kaposi sarcoma, pediatric rhabdomyosarcoma, nor uterine sarcoma\n* Patient must not have had a palliative or R2 resection\n* Patient must not require routine cross-sectional imaging of the chest\u002Flungs with CT\u002FMRI\u002Fpositron emission tomography (PET)\n* Patient must not have participation in another clinical trial that is incompatible with this study surveillance schema and follow-up regimen\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Pediatric patients (\\\u003C 18 years of age) and patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible. Child assent must be obtained as appropriate in accordance with institutional guidelines\n* Patient must be English speaking to be eligible for the quality of life (QOL) component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms","1 Year","85 Years",{"count":227,"type":20},1582,[23],"This phase III trial compares chest computed tomography (CT) to chest x-ray (CXR) for lung surveillance after curative-intent resection of high-risk truncal-extremity soft tissue sarcoma. Currently, complete oncologic resection (with or without radiation therapy) is the standard of care for most high-risk soft tissue sarcoma that has not spread to other parts of the body (localized). However, despite curative-intent resection, 20-40% of patients will develop cancer that has spread from where it first started (primary site) to other places in the body (distant metastases), with the lungs being the most common site. Thus, lung surveillance is important for detection of lung metastases in order to facilitate timely treatment. Although there is general agreement about the usefulness of postoperative surveillance, consensus is lacking regarding the optimal modality for lung surveillance after curative-intent resection for high-risk soft tissue sarcoma. Current National Comprehensive Cancer Network guidelines recommend chest imaging with CT or CXR every 3-6 months for 2-3 years, then every 6 months for the next two years, and then annually after that for high-risk tumors. Data from across the United States and internationally indicate that there is considerable variation in clinical practice with regards to the use of CXR versus CT chest for lung surveillance. The information gained from this trial may allow researchers to determine the effectiveness of varying imaging modalities needed for optimal surveillance for patients with extremity or truncal soft tissue sarcoma.",[231,232,233,234,127,235,236,237,238,239,240,155,241,186,187,242,27,34,26,243,96,244,245],"Adult Pleomorphic Rhabdomyosarcoma","AJCC Grade 2 Sarcoma","AJCC Grade 3 Sarcoma","Alveolar Soft Part Sarcoma","Clear Cell Sarcoma of Soft Tissue","Dedifferentiated Liposarcoma","Extraskeletal Ewing Sarcoma","Extraskeletal Myxoid Chondrosarcoma","Fibrosarcoma","Fibrosarcomatous Dermatofibrosarcoma Protuberans","Malignant Peripheral Nerve Sheath Tumor","Round Cell Sarcoma With EWSR1-non-ETS Fusion","Spindle Cell Sarcoma","Synovial Sarcoma","Undifferentiated Pleomorphic Sarcoma","2024-07-24",{"date":248,"type":39},"2024-07-30",{"date":250,"type":20},"2025-01-28",{"date":252,"type":20},"2032-11-01",{"name":254,"class":107},"ECOG-ACRIN Cancer Research Group"]