A Study to Evaluate Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorInstitut Claudius Regaud

About this trial

This is a phase II, multicenter, non-randomized study.

The main objective is to evaluate the treatment with hypofractionated radiation therapy in neo-adjuvant situations on wound healing in a population of aged patients (≥ 70 years old) or ≥ 65 years of age defined as "fragile" and treated for soft tissue sarcoma.

A maximum of 48 evaluable patients will be included in this study. The patients will receive an hypofractionated radiation therapy prior to conservative surgery.

Each patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery).

Eligibility criteria

Qualifiers

Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk.

Indication for neo-adjuvant or adjuvant radiotherapy.

Patient aged ≥ 70 years with a performance status ECOG ≤ 2 and/or aged 65 to 70 years with an ECOG of 2 and identified by the investigator as "fragile".

Patient affiliated to a Social Health Insurance in France.

Disqualifiers

Retroperitoneal, ORL and visceral sarcomas.

Previous radiotherapy in the area.

Metastatic disease.

Concomitant or sequential chemotherapy.

Trial design

Treatments tested in this trial

  • Hypofractionated Radiation Therapy
  • Conservative treatment

Treatment groups

48 Participants
are divided into 1 treatment group

Sponsors and collaborators