[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02701153":3,"trial-entities:NCT02701153":123,"trial-summary:NCT02701153":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":50,"secondary_outcomes":55,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":72,"eligibility_criteria":73,"std_ages":86,"locations":89,"central_contacts":108,"overall_officials":114,"references":117,"see_also_links":122},"NCT02701153","15-001657","Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort","RECRUITING","2028-02-03","2026-03","2026-03-10","2016-02-03","Jonsson Comprehensive Cancer Center","OTHER",true,"This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas prior to surgery. Hypofractionated 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.","PRIMARY OBJCETIVES:\n\nI. Grade \\>= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) at 2 years.\n\nSECONDARY OBJECTIVES:\n\nI. Evaluate local control, regional control, distant metastasis, progression free survival, and overall survival.\n\nII. Evaluate the functional outcomes as assessed using the musculoskeletal tumor rating scale (MSTS) and the Toronto Extremity Salvage Score (TESS).\n\nIII. Collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.\n\nIV. Investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.\n\nOUTLINE:\n\nPatients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.\n\nAfter completion of study treatment, patients are followed up at 3 months and then every 6 months for 5 years.",[18],"Recurrent Adult Soft Tissue Sarcoma",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},51,"ESTIMATED",[28,34,42,46],{"type":29,"name":30,"description":31,"armGroupLabels":32},"PROCEDURE","Conventional Surgery","Undergo surgery",[33],"Treatment (hypofractionated radiation therapy)",{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"RADIATION","Hypofractionated Radiation Therapy","Undergo hypofractionated radiation therapy",[33],[40,41],"Hypofractionated Radiotherapy","hypofractionation",{"type":13,"name":43,"description":44,"armGroupLabels":45},"Laboratory Biomarker Analysis","Correlative studies",[33],{"type":13,"name":47,"description":48,"armGroupLabels":49},"Questionnaire Administration","Ancillary studies",[33],[51],{"measure":52,"description":53,"timeFrame":54},"Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)","Interim reports will be prepared every six months until the results of the study are published. In general, the interim reports will contain information about patient accrual rate with projected completion dates, status of question-answer (QA) review and compliance rate of treatment per protocol, and the frequencies and severity of toxicity.","Up to 2 years",[56,60,63,65,67],{"measure":57,"description":58,"timeFrame":59},"Distant metastasis","Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.","Up to 3 years",{"measure":61,"description":62,"timeFrame":59},"Local failure","Cumulative incidence approach (Kaplan-Meier \\[K-M\\] plots and Cox proportional hazard modeling) will be used.",{"measure":64,"description":58,"timeFrame":59},"Overall survival",{"measure":66,"description":58,"timeFrame":59},"Progression free survival",{"measure":68,"description":58,"timeFrame":59},"Regional failure","ALL","18 Years",null,false,{"inclusion":74,"exclusion":81,"raw_text":85},[75,76,77,78,79,80],"Histologically confirmed soft tissue sarcoma of the extremity\u002Ftrunk","Intermediate or high grade sarcoma","Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)","Recurrent, any grade, no previous radiation therapy","Karnofsky performance status (KPS) \\>= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2","If a woman is of childbearing potential, a negative serum pregnancy test must be documented",[82,83,84],"Active treatment of a separate malignancy","History of prior irradiation to the area to be treated","Pre-operative chemotherapy (post-op acceptable)","Inclusion Criteria:\n\n* Histologically confirmed soft tissue sarcoma of the extremity\u002Ftrunk\n* Intermediate or high grade sarcoma\n* Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)\n* Recurrent, any grade, no previous radiation therapy\n* Karnofsky performance status (KPS) \\>= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2\n* If a woman is of childbearing potential, a negative serum pregnancy test must be documented\n\nExclusion Criteria:\n\n* Active treatment of a separate malignancy\n* History of prior irradiation to the area to be treated\n* Pre-operative chemotherapy (post-op acceptable)",[87,88],"ADULT","OLDER_ADULT",[90],{"facility":91,"status":7,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":105},"UCLA \u002F Jonsson Comprehensive Cancer Center","Los Angeles","California","90095","United States",[97,102],{"name":98,"role":99,"phone":100,"email":101},"Vincent Basehart","CONTACT","310-267-8954","vbasehart@mednet.ucla.edu",{"name":103,"role":104},"Anusa Kalbasi, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":106,"lon":107},34.05223,-118.24368,[109],{"name":110,"role":99,"phone":111,"phoneExt":112,"email":113},"Jackie Hernandez","310-206-8477","97624","jhernandez@mednet.ucla.edu",[115],{"name":116,"affiliation":91,"role":104},"Anusa Kalbasi, MD",[118],{"pmid":119,"type":120,"citation":121},"41405883","DERIVED","Nikitas J, Kendal JK, Savjani RR, Jackson N, Peterson N, Deng J, Hernandez J, Chong N, Singh AS, Chmielowski B, Federman NC, Crompton JG, Kadera BE, Wessel LE, Christ AB, Nelson SD, Dry SM, Weidhaas JB, Steinberg ML, Bernthal NM, Eilber FC, Kalbasi A, Reddy VK. Five-Day Preoperative Radiation Therapy for Patients With High-Risk Soft Tissue Sarcoma: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2550195. doi: 10.1001\u002Fjamanetworkopen.2025.50195.",[],{"nct_id":4,"conditions":124,"biomarkers":126},[125],"Soft Tissue Sarcoma",[],{"nct_id":4,"found":14,"summary":128,"prompt_version":138},{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This is a Phase II interventional study. It will include 51 participants with recurrent soft tissue sarcoma.","completed","Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas","This study is looking at a new way to give radiation therapy before surgery for soft tissue sarcomas. It's called hypofractionated radiation therapy, which means you get higher doses of radiation over a shorter time (5 days). Researchers want to see if this method can kill more cancer cells and cause fewer side effects. You might be able to join if you have an intermediate or high-grade soft tissue sarcoma in an arm, leg, or your body, and it has come back. The main goal is to see how many people experience side effects like scarring, joint stiffness, or swelling up to two years after treatment. The study is currently unclear about its recruitment status and plans to enroll 51 participants.","After treatment, you will have follow-up visits at 3 months and then every 6 months for 5 years.",121,"You would receive hypofractionated radiation therapy for 5 days, followed by surgery 2-12 weeks later. You will also complete questionnaires and provide samples for laboratory analysis.","Not stated in the trial record.",[36],"v2"]