NCT06476704Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 21 Jun 2024
- Start date
- 1 Jul 2026
- Primary completion date
- 15 Oct 2028
- Lead sponsor
- Centre Paul Strauss
- Diseases
- Sarcoma
- NCT number
- NCT06476704
- EU CT number
- 2024-515668-30-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- From 1 Jul 2026 to the primary completion date, 15 Oct 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiation in the area
Other illness
- Patient with metastatic disease, other concomitant cancer or history of cancer treated and controlled within the previous 3 years.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CGFL Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| ICANS Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.