Short Course of Preoperative Radiotherapy in Head and Neck, Trunk, and Extremity Soft Tissue Sarcomas: A Randomized Phase II Clinical Trial

What this Trial Is About

Researchers are evaluating different schedules of preoperative radiotherapy for patients with intermediate to high grade soft tissue sarcomas located in the head and neck area, trunk, chest wall, or extremities. This study compares a modestly hypofractionated radiotherapy schedule of 14 sessions at 3 Gy each over three weeks to an even shorter regimen of 5 sessions at 6 Gy each over one week. The main goal is to see if both approaches have similar rates of wound complications up to 120 days after surgery and comparable local control at two years. Participants will be randomly assigned to one of two groups. Arm A receives 42 Gy total dose divided into 14 daily treatments of 3 Gy over three weeks. Arm B receives 30 Gy total dose divided into 5 daily treatments of 6 Gy over one week. Both groups will undergo surgery after radiotherapy. The study is based on previous evidence that shorter radiotherapy schedules may be as safe and effective as conventional longer courses, offering benefits such as patient convenience and reduced pressure on radiotherapy equipment. During the trial, participants will be closely followed up with regular visits for up to five years to monitor short-term toxicity within 120 days after surgery, local control of the sarcoma, and any long-term side effects. Patients will complete quality of life and cost-effectiveness questionnaires. Researchers will also track patients who do not proceed to surgery. The total participation duration includes treatment, surgery, and long-term follow-up to assess both safety and effectiveness outcomes.

Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas