Phase II Study of Pre-Operative Hypofractionated Radiation Therapy for Patients 70 Years or Older or Fragile Patients 65 to 70 Years with Limb or Trunk Soft Tissue Sarcoma

What this Trial Is About

Researchers are evaluating hypofractionated radiation therapy given before surgery in older or fragile patients treated for soft tissue sarcoma of the limbs or trunk. This phase II, multicenter, non-randomized study focuses on patients aged 70 or older, or those aged 65 to 70 identified as fragile, to assess how this treatment affects wound healing after surgery. The study will include up to 48 patients and aims to improve understanding of treatment outcomes in this specific population. Participants will receive hypofractionated intensity-modulated radiation therapy delivered in 5 doses of 6 Gy each, totaling 30 Gy over approximately one week. About 1.5 to 2 months after radiation therapy, patients will undergo conservative surgery involving wide resection but excluding amputation. This approach is designed to preserve function while addressing the sarcoma. During the study, patients will be followed for up to three years after completing both radiation and surgery. Researchers will monitor surgical complications within six months and evaluate longer-term outcomes such as disease-free survival, wound healing, quality of life, autonomy, geriatric assessments, and treatment toxicities. Various questionnaires and criteria will be used to assess these measures, ensuring comprehensive monitoring of patient health and recovery.

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.