[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552716":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":40,"locations":47,"responsibleParty":76,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":26,"enrollmentInfo":92,"targetDuration":26,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":107,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Centre Paul Strauss","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypofractionated radiotherapy + Liposomal Transcorcetin (L-TC)","EXPERIMENTAL","L-TC as an IV infusion over 90 minutes at a fixed dose of 300 mg daily before each HFRT fraction, for a total of 5 days corresponding to the planned five daily HFRT fractions. The intravenous infusion should begin 2 hours before each HFRT fraction. Radiotherapy is scheduled to coincide with the plasma peak, which occurs approximately 2 hours after the start of the infusion. + HFRT treatment will be administered in control group as 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.",[13],"Drug: Administration of L-TC",{"label":15,"type":16,"description":17,"interventionNames":18},"Hypofractionated radiotherapy alone","ACTIVE_COMPARATOR","HFRT treatment will be administered in control group as 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.",[19],"Radiation: HFRT alone",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Administration of L-TC","Administration of L-TC (300 mg) as an IV perfusion, daily before each radiotion session",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"RADIATION","HFRT alone","HFRT : 30 Gy in 5 fractions of 6 Gy.\n\n1 fraction per day, 5 days per week.",[15],[33,37],{"name":34,"affiliation":35,"role":36},"Isabelle CHAMBRELANT, MD","Institut de cancérologie Strasbourg Europe","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":35,"role":39},"Georges NOEL, MD, PhD","STUDY_CHAIR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Manon VOEGELIN","CONTACT","368339523","+33","promotion-rc@icans.eu",[48,64],{"facility":49,"status":26,"city":50,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"CGFL","Dijon","France","FR",{"type":54,"coordinates":55},"Point",[56,57],5.01391,47.31344,{"lat":57,"lon":56},[60],{"name":61,"role":43,"phone":62,"phoneExt":26,"email":63},"Gilles TRUC","33380737518","gtruc@cgfl.fr",{"facility":65,"status":26,"city":66,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"ICANS","Strasbourg",{"type":54,"coordinates":68},[69,70],7.74553,48.58392,{"lat":70,"lon":69},[73],{"name":74,"role":43,"phone":75,"phoneExt":26,"email":46},"Georges NOEL","33368339523",{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[79],{"name":80,"class":81},"LEAF4Life, Inc.","INDUSTRY","100552716","phase-2-study-of-preoperative-radiation-therapy-with-concomitant-liposomal-transcrocetin-l-tc-in-soft-tissue-sarcomas-100552716",false,"NCT06476704","Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas","Phase 2 Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas","PRACTISS","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Localized or locally advanced soft tissue sarcoma of extremity proven by biopsy histological grade 2 and 3.\n* Pathological expert proof-reading in reference centers\n* HFRT and surgery planned (regardless the potential inclusion in this trial) as decided in a multidisciplinary tumor board, in reference centre (European Society for Medical Oncology (ESMO) guideline 2021)\n* R0 surgery is feasible, in reference centers\n* Pre-biopsy MRI available\n* Performance status of 0-2 and life expectancy of at least 6 months\n\nExclusion Criteria:\n\n* Patient who cannot undergo MRI\n* Patients with localized or locally advanced soft tissue sarcoma of extremity proven by biopsy with histological grade 1\n* Previous radiation in the area\n* Woman who is pregnant or breastfeeding\n* Soft tissue sarcoma developed in irradiated area.\n* Patients with myxoid liposarcoma, embryonal or alveolar rhabdomyosarcoma, Ewing sarcoma, osteosarcoma, angiosarcoma, primitive neuroectodermal tumor, desmoid-type fibromatosis, or dermatofibrosarcoma protuberans\n* Patient with metastatic disease, other concomitant cancer or history of cancer treated and controlled within the previous 3 years.","ALL","18 Years",{"count":93,"type":94},42,"ESTIMATED","INTERVENTIONAL",[97],"PHASE2","This is phase II randomized, multicenter study of treatment with L-TC and preoperative HFRT in patients who were aged 18 years or older with documented localised or locally advanced soft-tissue sarcoma of the extremity.\n\nEligible patients will be randomly assigned 2:1 to receive a preoperative HFRT alone (Arm A) or L-TC with preoperative HFRT (Arm B).",[100],"Sarcoma",[102,103,104,105,106],"hypofractionated radiotherapy","soft tissue sarcoma","hypoxia","liposomal transcrocetin","neo-adjuvant","NOT_YET_RECRUITING","2026-06-03",{"date":110,"type":111},"2026-06-04","ACTUAL",{"date":113,"type":94},"2026-07-01",{"date":115,"type":94},"2033-06-01",{"name":5,"class":6},2]