Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas

Starting soon · Phase 2

Conditions studied: Sarcoma

In brief

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).

Key facts

Study ID

NCT06476704

Run by

Centre Paul Strauss

People needed

42

Starts

2026-07-01

Expected to finish

2033-06-01

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patient who cannot undergo MRI
• Patients with localized or locally advanced soft tissue sarcoma of extremity proven by biopsy with histological grade 1
• Previous radiation in the area
• 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
• Patient with metastatic disease, other concomitant cancer or history of cancer treated and controlled within the previous 3 years.

Where it is running

• CGFL — Dijon, France
• ICANS — Strasbourg, France

Full record on ClinicalTrials.gov

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