Assessment of the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall
Recruiting now · Phase 2
Conditions studied: Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma (Excluding GIST), Soft Tissue Sarcoma of the Trunk and Extremities, Soft Tissue Sarcoma of the Limb
In brief
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.
Key facts
- Study ID
- NCT07507773
- Run by
- Centre Oscar Lambret
- People needed
- 135
- Starts
- 2026-07-21
- Expected to finish
- 2035-06-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Centre Oscar Lambret — Lille, France (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.