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

Study acronym: NEORASARC
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Start date changed from estimate of Jun 1, 2026 to Jul 21, 2026v3
  2. Notable Recruitment openedv2 Show 4 more changesShow less
    • Start date: Apr 1, 2026 to Jun 1, 2026
    • Primary completion pushed from Apr 1, 2032 to Jun 1, 2032
    • Study completion pushed from Apr 1, 2035 to Jun 1, 2035
    • Site details revised
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,026 trials monitored
See 67 trials at risk
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.
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
(from sponsor)
Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma (Excluding GIST), Soft Tissue Sarcoma of the Trunk and Extremities, Soft Tissue Sarcoma of the Limb
Related terms Sarcoma
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov