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NOT YET RECRUITING
NCT07507773
PHASE2

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

Sponsor: Centre Oscar Lambret

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2026-04-01

Completion Date

2035-04-01

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

RADIATION

Moderately hypofractionated neoadjuvant radiotherapy

Intensity-modulated radiotherapy with a moderately hypofractionated scheme consisting of 15 fractions of 2.7 Gy administered over 3 weeks.

Locations (1)

Centre Oscar Lambret

Lille, France