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
Locations
11Sponsors and collaborators
Institut Claudius Regaud
Lead sponsor