NCT07507773RecruitingPhase 2
Assessment of the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall
Phase II Clinical Trial Assessing the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall, Incorporating Translationnal Research
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 135 (estimated)
- First submitted
- 23 Mar 2026
- Start date
- Jul 2026
- Primary completion date
- Jun 2032
- Lead sponsor
- Centre Oscar Lambret
- Diseases
- Sarcoma
- NCT number
- NCT07507773
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 135
- From Jul 2026 to the primary completion date, Jun 2032
- 1 site 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
- Tumor considered inoperable even after radiotherapy, according to the multidisciplinary consultation meeting ;
- Indication of neoadjuvant or adjuvant chemotherapy ;
Other illness
- Metastatic disease (including local lymph node diffusion) ;
Other
- Visceral or retroperitoneal sarcoma ;
- Ewing tumor of soft tissue, desmoid tumor, embryonal or alveolar rhabdomyosarcoma ;
- Pregnant or breastfeeding women ;
- Patients under protective measures ;
- Patient refusal.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.