[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06905132":3,"trial-entities:NCT06905132":95,"trial-summary:NCT06905132":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":42,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":69,"locations":72,"central_contacts":85,"overall_officials":90,"references":93,"see_also_links":94},"NCT06905132","104131","Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma","Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial","RECRUITING","2030-03-27","2026-03","2026-03-30","2025-04-01","Medical University of South Carolina","OTHER",true,"The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and\u002For leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body.","This study is for subjects that have been diagnosed with cancer in their arm, leg, or trunk (the part of the body that involves the chest, abdomen, and pelvis). The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and\u002For leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body. This study will look at early side effects and effectiveness of preoperative 5-day Hypofractionated radiotherapy. Active participation in the study will take about 12 visits and are completed once the participant has a 6-month post-operation visit.",[19],"Soft Tissue Sarcoma",[21,22,23],"STS","HFRT","SFRP2","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},40,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"RADIATION","Hypofractionated Radiation Therapy","Participants will receive preoperative 5-day HFRT (30Gy\u002F5fx once daily over consecutive weekdays) followed by \"standard of care\" wide local excision 2-6 weeks later.",[34],[38],{"measure":39,"description":40,"timeFrame":41},"HFRT Safety","Evaluate the safety of 5-day HFRT as measured by the rates of major wound complications occurring within 120 days of surgery.","6 months",[43,46],{"measure":44,"description":45,"timeFrame":41},"Treatment Response","Evaluate treatment response to 5-day HFRT as measured by pathologic response. Pathologic response is defined as percent necrosis and percent viable tumor.",{"measure":47,"description":48,"timeFrame":41},"Safety Profile","Evaluate the safety profile of 5-day HFRT, specifically the proportion of patients experiencing acute toxicities and late toxicities","ALL","18 Years",null,false,{"inclusion":54,"exclusion":62,"raw_text":68},[55,56,57,58,59,60,61],"Willingness and provision of informed consent via signed and dated copy.","Histologically confirmed STS of extremity or trunk.","Male or female, aged greater than or equal to 18 years old","ECOG performance status 0-3","Meets screening criteria for receipt of radiotherapy.","Deemed eligible for wide local excision.","Patient and\u002For physician identified possible barriers to receiving a 5-week course of conventionally fractionated preoperative radiotherapy. Potential barriers include but are not limited to concern for local progression that could precluded or complicate limb sparing surgery, concern for distant progression that could result in patient being non-operative, financial and\u002For physical burden of travel for daily treatments, financial burden of time away from work or caregiving.",[63,64,65,66,67],"Distant metastatic disease","Prior radiation therapy in the proposed treatment area","Simultaneous treatment of another malignancy","Women who are pregnant or plan to become pregnant during the period of radiation therapy","Planned concurrent administration of chemotherapy and radiation therapy","Inclusion Criteria:\n\n* Willingness and provision of informed consent via signed and dated copy.\n* Histologically confirmed STS of extremity or trunk.\n* Male or female, aged greater than or equal to 18 years old\n* ECOG performance status 0-3\n* Meets screening criteria for receipt of radiotherapy.\n* Deemed eligible for wide local excision.\n* Patient and\u002For physician identified possible barriers to receiving a 5-week course of conventionally fractionated preoperative radiotherapy. Potential barriers include but are not limited to concern for local progression that could precluded or complicate limb sparing surgery, concern for distant progression that could result in patient being non-operative, financial and\u002For physical burden of travel for daily treatments, financial burden of time away from work or caregiving.\n\nExclusion Criteria:\n\n* Distant metastatic disease\n* Prior radiation therapy in the proposed treatment area\n* Simultaneous treatment of another malignancy\n* Women who are pregnant or plan to become pregnant during the period of radiation therapy\n* Planned concurrent administration of chemotherapy and radiation therapy",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":13,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":82},"Charleston","South Carolina","29401","United States",[79],{"name":80,"role":81},"Jennifer Harper, MD","CONTACT",{"lat":83,"lon":84},32.77632,-79.93275,[86],{"name":87,"role":81,"phone":88,"email":89},"HCC Clinical Trials Office","843-792-9321","hcc-clinical-trials@musc.edu",[91],{"name":80,"affiliation":13,"role":92},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":96,"biomarkers":97},[19],[],{"nct_id":4,"found":15,"summary":99,"prompt_version":108},{"design":100,"status":101,"heading":6,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 participants.","completed","This study is testing a new way to treat soft tissue sarcoma (a type of cancer that grows in soft tissues like muscle or fat) in your arm, leg, or trunk (chest, abdomen, and pelvis). It uses a shorter course of radiation therapy called Hypofractionated Radiation Therapy (HFRT) given over 5 days before surgery. The goal is to treat the cancer and prevent it from spreading, while also protecting healthy tissue. Researchers will be looking at how safe HFRT is and any early side effects. You may be able to join if you are 18 or older, have a confirmed soft tissue sarcoma in an arm, leg, or trunk, and are healthy enough for radiation and surgery. This study plans to enroll 40 participants.","The primary endpoint, HFRT Safety, is measured at 6 months.",124,"Active participation in the study will involve about 12 visits. These visits are completed once you have a 6-month post-operation visit.","Not stated in the trial record.",[34],"v2"]