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

NCT07507773 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • Soft Tissue Sarcoma Adult
  • Soft Tissue Sarcoma (Excluding GIST)
  • Soft Tissue Sarcoma of the Trunk and Extremities
  • Soft Tissue Sarcoma of the Limb

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.

Sponsors & Collaborators

  • Canther, Lille

    collaborator UNKNOWN
  • Centre de traitement des données du Cancéropôle Nord-Ouest, Centre F. BACLESSE, Caen, France

    collaborator UNKNOWN
  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Abel CORDOBA, MD · Centre Oscar Lambret

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2032-04-01
Completion
2035-04-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507773 on ClinicalTrials.gov