[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623398":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":20,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":77,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypofractionated Radiotherapy Combined with Immunotherapy","EXPERIMENTAL","Patients receive hypofractionated radiotherapy with 43.5Gy in 15 fractions, combined with immunotherapy, followed by surgery done at 6-10 weeks post-radiotherapy (RT).",[13],"Radiation: ultra-hypofractionated radiotherapy combined with immunotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","ultra-hypofractionated radiotherapy combined with immunotherapy","ultra-hypo-fractionated radiotherapy with 43.5Gy in 15 fractions combined with immunotherapy, followed by surgery done at 6 to 10 weeks post-RT",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Ning-Ning Lu","CONTACT","+868611804268","Ning-Ning.Lu@hotmail.com",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences","Beijing","Beijing Municipality","100021","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.39723,39.9075,{"lat":39,"lon":38},[42],{"name":23,"role":24,"phone":43,"phoneExt":20,"email":26},"+86 01087787630",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","NINGNING LU","Principle Investigator","100623398","preoperative-hypofractionated-rt--immunotherapy--surgery-for-retroperitoneal-sarcoma-fusion-02-100623398",false,"NCT07396116","Preoperative Hypofractionated RT + Immunotherapy & Surgery for Retroperitoneal Sarcoma (FUSION-02)","Preoperative Hypofractionated Radiotherapy Combined With Immunotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-02)","FUSION-02","Inclusion Criteria:\n\n* Diagnosis \\& Indication: Primary or recurrent abdominopelvic soft tissue sarcoma. Patients are deemed to have a high probability of R1\u002FR2 resection with upfront surgery and are confirmed to require radiotherapy following Multidisciplinary Team (MDT) discussion.\n* Target Volume: In cases of multifocal disease, all lesions must be safely encompassable within a single radiotherapy target volume.\n* Age: Age ≥ 18 years.\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status 0-2; American Society of Anesthesiologists (ASA) score ≤ 2; patients must be expected to tolerate surgery and radiotherapy.\n* Pathology: Histologically confirmed soft tissue sarcoma.\n* Measurability: Presence of evaluable lesions.\n* Life Expectancy: Life expectancy \\> 5 years.\n* Hematological \\& Hepatic Function: Adequate organ function\n* Renal Function: Adequate renal function defined as Glomerular Filtration Rate (GFR) ≥ 50 ml\u002Fmin (calculated by Cockcroft-Gault formula), and split renal function imaging confirms function in the contralateral kidney.\n* Contraception: Female patients of childbearing potential, or male patients with female partners of childbearing potential, must agree to use effective contraception during the entire treatment period and for 6 months after the last dose.\n* Consent: Signed informed consent form.\n* Follow-up: Capable of complying with follow-up requirements.\n\nExclusion Criteria:\n\n* Significant Comorbidities: Patients with the following concurrent conditions: active hemorrhage, ulceration, intestinal perforation, intestinal obstruction, uncontrolled hypertension, cardiac insufficiency (NYHA Class III-IV), severe hepatic or renal dysfunction (Grade 4), mesenteric ischemia, or severe inflammatory bowel disease (IBD).\n* Excluded Histologies: Other pathological types, including Gastrointestinal Stromal Tumor (GIST), sarcomatoid carcinoma, sarcomas primarily treated with chemotherapy (e.g., rhabdomyosarcoma and PNET), desmoid fibromatosis, and benign tumors.\n* Unresectability: Tumor invasion into critical structures such as the liver, pancreatic head, or abdominal aorta, rendering the tumor deemed unresectable.\n* Prior Radiotherapy: History of prior radiotherapy to the same anatomical region.\n* Distant Metastasis: Presence of distant metastasis (M1) confirmed by comprehensive imaging\u002Fexamination within 4 weeks prior to enrollment.\n* Contraindications to Surgery\u002FProtocol: Presence of other severe medical comorbidities that contraindicate surgery or preclude participation in the study.\n* Planned Neoadjuvant Chemotherapy: Patients scheduled to receive (concurrent) neoadjuvant chemotherapy.\n* Recent Systemic Therapy: Receipt of chemotherapy or other systemic treatments within 4 weeks prior to enrollment.","ALL","18 Years",{"count":59,"type":60},28,"ESTIMATED","INTERVENTIONAL",[63],"NA","To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy combined with immunotherapy followed by surgery for retroperitoneal sarcoma",[66,67,68,69,70],"Soft Tissue Sarcoma (STS)","Retroperitoneal Sarcoma","Immunotherapy","Radiotherapy Side Effect","Ultra-hypofractionated Radiotherapy",[72,73,74,75,76],"hypofractionated radiotherapy","retroperitoneal sarcoma","soft tissue sarcoma","immunotherapy","peri-operative complications","NOT_YET_RECRUITING","2026-02-10",{"date":80,"type":81},"2026-02-12","ACTUAL",{"date":80,"type":60},{"date":84,"type":60},"2028-12-31",{"name":5,"class":6},1]