Personalized Preoperative Proton or X-ray Radiotherapy Over 3 Weeks for Localized Soft Tissue Sarcoma in Adults

What this Trial Is About

Researchers are evaluating whether a personalized approach using proton beam therapy PBT for patients with localized soft tissue sarcoma can reduce long-term radiation side effects without increasing surgical complications or affecting treatment effectiveness. This phase II trial includes patients with newly diagnosed soft tissue sarcoma in the head, neck, extremity, girdle, or trunk wall areas. The study also investigates biomarkers to predict response to radiation therapy by analyzing tumor DNA, blood molecules, and MRI scans. Each participant will have two radiation plans createdone using protons and one using X-rays photons. A weekly national meeting of sarcoma specialists will review these plans and recommend either proton or X-ray radiotherapy based on clinical evaluation and toxicity thresholds. Treatment involves a standard dose of 42.75 Gy delivered in 15 fractions over 3 weeks before surgery. The study includes collection of tumor tissue, blood, plasma, and serum for further research. Participants will be followed up to five years after treatment. Researchers will monitor surgical complications within 120 days post-surgery, as well as overall survival, disease-free survival, local recurrence-free survival, response rates, quality of life, and functional outcomes. Patients will complete questionnaires and attend scheduled assessments during the study period, which aims to include 110 patients across multiple centers in Norway.

Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma