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
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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