Assessment of the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft… (NCT07507773) | Clinical Trial Compass
RecruitingPhase 2
Assessment of the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall
France135 participantsStarted 2026-06-01
Plain-language summary
This trial aims to assess the long-term efficacy of moderately hypofractionated neoadjuvant radiotherapy for soft tissue sarcoma in the limbs or trunk wall. The primary outcome is local disease control, assessed by the cumulative incidence of progression/recurrence.
After informed consent has been obtained and eligibility criteria have been checked, a baseline assessment will be performed followed by the experimental treatment: intensity-modulated radiotherapy with a moderately hypofractionated regimen consisting in 15 fractions of 2.7 Gy administered over 3 weeks.
a follow-up assessment will be performed 3 to 4 weeks after the last radiotherapy session.
Tumor resection will be performed 4 to 8 weeks after the radiotherapy. Patients will then be followed up until the end of the study; planned 5 years after the last inclusion.
Radiotherapy will be evaluated in terms of safety and efficacy.
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:
* Patient aged ≥ 18 years ;
* Localised sarcoma of a limb, the root of a limb, or the trunk wall ;
* Histologically confirmed diagnosis of soft tissue sarcoma regardless of the grade ;
* Diagnosis biopsy performed at Centre Oscar Lambret, with specimen available for translational research ;
* Indication of neoadjuvant radiotherapy according to the multidisciplinary consultation meeting ;
* Tumor considered operable with a curative intent and conservative intent according to the multidisciplinary consultation meeting ;
* Affiliation to the French National Social Security System ;
* Informed and signed consent
Exclusion Criteria:
* Metastatic disease (including local lymph node diffusion) ;
* Visceral or retroperitoneal sarcoma ;
* Tumor considered inoperable even after radiotherapy, according to the multidisciplinary consultation meeting ;
* Indication of neoadjuvant or adjuvant chemotherapy ;
* Ewing tumor of soft tissue, desmoid tumor, embryonal or alveolar rhabdomyosarcoma ;
* Pregnant or breastfeeding women ;
* Patients under protective measures ;
* Patient refusal.
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
1
Local control of the disease at the two-year follow-up
Timeframe: From enrollment to the two-year follow-up