Tests liposomal transcrocetin with radiation before surgery for soft tissue sarcoma
Tests a drug with radiation before surgery in adults with soft tissue sarcoma.
Plain-language title generated from the registry record
Registry title: Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas
Key facts
- Where
- Dijon and Strasbourg, FranceSee the 2 sites
- Phase
- Phase 2
Where in France
- CGFLDijon, FranceNo longer taking part
- ICANSStrasbourg, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Paul Strauss
- Trial code
- NCT06476704EU 2024-515668-30-00
- Record updated
- 4 June 2026
- Original description
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.Read full original descriptionShow less
Phase 2 Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas
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.
Eligible patients will be randomly assigned 2:1 to receive a preoperative HFRT alone (Arm A) or L-TC with preoperative HFRT (Arm B).
Inclusion: Age ≥ 18 years; Localized or locally advanced soft tissue sarcoma of extremity proven by biopsy histological grade 2 and 3; Pathological expert proof-reading in reference centers; 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); R0 surgery is feasible, in reference centers; Pre-biopsy MRI available; Performance status of 0-2 and life expectancy of at least 6 months.
Exclusion: Previous radiation in the area; Patient with metastatic disease, other concomitant cancer or history of cancer treated and controlled within the previous 3 years; Patient who cannot undergo MRI; Patients with localized or locally advanced soft tissue sarcoma of extremity proven by biopsy with histological grade 1; Woman who is pregnant or breastfeeding; Soft tissue sarcoma developed in irradiated area; Patients with myxoid liposarcoma, embryonal or alveolar rhabdomyosarcoma, Ewing sarcoma, osteosarcoma, angiosarcoma, primitive neuroectodermal tumor, desmoid-type fibromatosis, or dermatofibrosarcoma protuberans.