Phase 2 Study of Moderately Hypofractionated Neoadjuvant Radiotherapy for Treating Soft Tissue Sarcoma in Limbs or Trunk Wall with Translational Research

What this Trial Is About

This trial investigates the long-term effectiveness of moderately hypofractionated neoadjuvant radiotherapy for soft tissue sarcoma located in the limbs or trunk wall. The study aims to evaluate how well this radiotherapy controls local disease progression or recurrence over time. It is a Phase II clinical trial sponsored by Centre Oscar Lambret, focusing on safety and efficacy outcomes for patients with operable soft tissue sarcoma. Participants will receive intensity-modulated radiotherapy delivered in 15 fractions of 2.7 Gy each over 3 weeks for a total dose of 40.5 Gy. After completing radiotherapy, an MRI scan will be performed 3 to 4 weeks later. Tumor resection surgery is scheduled between 4 and 8 weeks following the end of radiotherapy. Blood samples will be collected at baseline and before surgery for translational research purposes. Throughout the study, participants will undergo clinical examinations, MRI scans, and complete quality of life questionnaires at baseline and during follow-up visits. These follow-up visits occur every 4 months for the first 2 years, every 6 months for the next 3 years, and then annually until the study concludes five years after the last participant is enrolled. The primary outcome measured is local disease control at two years, with additional assessments including survival, limb function, tumor response, and quality of life.

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