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

NCT07507773 | Not Yet Recruiting Phase 2

• 2 other identifiers: NEORASARC-25022025-A02053-46
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sarcoma; Trunk; Limb; Radiotherapy; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Local control of the disease at the two-year follow-up

  Local control of the disease will be assessed by cumulative incidence of local progression / recurrence. The main primary outcome analysis will focus on this incidence at the two-year follow-up. The cumulative incidence of local progression / recurrence will be estimated by considering the time between the start of radiotherapy and the date of local progression / recurrence. For patients who are free of local progression / recurrence, this time will be censored at the last follow-up. Death without prior local progression / recurrence and metastatic progression / recurrence without prior local progression / recurrence will be considered competing events. Pre-operative tumor assessment will be performed according to the RECIST 1.1 criteria. For the main analysis, a progressive disease according to RECIST 1.1 criteria during or at the end of radiotherapy will not be considered as an event if the patient remains eligible for surgical resection.

  From enrollment to the two-year follow-up

Secondary Outcomes (12)

• Control of the disease at the two-year follow-up

  From enrollment to the end of study, planned 5 years after the last enrollment

• Local control of the disease at the two-year follow-up - sensitivity analysis

  From enrollment to the two-year follow-up

• Overall survival

  From enrollment to the end of study, planned 5 years after the last enrollment

• Incidence of amputation

  From enrollment to the end of study, planned 5 years after the last enrollment

• Radiological response

  From enrollment to the post radiotherapy MRI planned 3 to 4 weeks after the end of radiotherapy.

Study Arms (1)

Neoadjuvant radiotherapy

EXPERIMENTAL

Neoadjuvant radiotherapy as described in the "intervention description" field, followed by a tumor resection 4 to 8 after the last session of radiotherapy.

Radiation: Moderately hypofractionated neoadjuvant radiotherapy

Interventions

Moderately hypofractionated neoadjuvant radiotherapy RADIATION

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

Neoadjuvant radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged ≥ 18 years ;
• Localised sarcoma of a limb, the root of a limb, or the trunk wall ;
• Histologically confirmed diagnosis of soft tissue sarcoma regardless of the grade ;
• Diagnosis biopsy performed at Centre Oscar Lambret, with specimen available for translational research ;
• Indication of neoadjuvant radiotherapy according to the multidisciplinary consultation meeting ;
• Tumor considered operable with a curative intent and conservative intent according to the multidisciplinary consultation meeting ;
• Affiliation to the French National Social Security System ;
• Informed and signed consent

You may not qualify if:

• Metastatic disease (including local lymph node diffusion) ;
• Visceral or retroperitoneal sarcoma ;
• Tumor considered inoperable even after radiotherapy, according to the multidisciplinary consultation meeting ;
• Indication of neoadjuvant or adjuvant chemotherapy ;
• Ewing tumor of soft tissue, desmoid tumor, embryonal or alveolar rhabdomyosarcoma ;
• Pregnant or breastfeeding women ;
• Patients under protective measures ;
• Patient refusal.

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Canther, Lille: collaborator
• Centre de traitement des données du Cancéropôle Nord-Ouest, Centre F. BACLESSE, Caen, France: collaborator

Study Sites (1)

Centre Oscar Lambret

Lille, 59000, France

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Abel CORDOBA, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien THERY

CONTACT

(0)320295918; promotion@o-lambret.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2035
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)