Clinical Trial

Assessment of the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall

Study acronym: NEORASARC
Recruiting Phase 2
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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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-06-23
notable Primary completion pushed: 2032-04-01 -> 2032-06-01 2026-06-23
minor Completion pushed: 2035-04-01 -> 2035-06-01 2026-06-23
Trial Details
NCT Number NCT07507773
Lead Sponsor Centre Oscar Lambret
Collaborators: Canther, Lille, Centre de traitement des données du Cancéropôle Nord-Ouest, Centre F. BACLESSE, Caen, France
Conditions Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma (Excluding GIST), Soft Tissue Sarcoma of the Trunk and Extremities, Soft Tissue Sarcoma of the Limb
Enrollment 135 participants
Start Date 2026-07-21
Primary Completion 2032-06-01 (estimated)
Study Completion 2035-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-23