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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Oscar Lambret

About this trial

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.

Eligibility criteria

Qualifiers

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 ;

Disqualifiers

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 ;

Trial design

Treatments tested in this trial

  • Moderately hypofractionated neoadjuvant radiotherapy

Treatment groups

135 Participants
are divided into 1 treatment group

Sponsors and collaborators

Centre Oscar Lambret

Lead sponsor

Canther, Lille

Collaborator

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

Collaborator