Not Yet RecruitingPhase 2

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

France42 participantsStarted 2026-07-01

Plain-language summary

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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of the efficacy of the L-TC treatment in combination with preoperative hypofractionated radiotherapy (HFRT)

Timeframe: At surgery (Between 4 and 8 weeks after the end of radiotherapy)

Trial details

NCT IDNCT06476704

SponsorCentre Paul Strauss

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10-15

Contact for this trial

Manon VOEGELIN

368339523 promotion-rc@icans.eu

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