Phase III Study Comparing Adjuvant Radiotherapy to Observation After Complete Surgery for Stage II or III Thymoma

What this Trial Is About

Researchers are studying whether adding radiotherapy after complete surgical removal improves survival in patients with stage II or III thymoma. This study aims to clarify the benefit of adjuvant radiotherapy since previous research shows better outcomes with complete resection but the role of additional radiotherapy remains unclear. The trial is sponsored by Fudan University and focuses on patients with this specific type and stage of thymoma. Participants are randomly assigned to one of two groups one group receives adjuvant radiotherapy delivering a total of 50Gy divided into 25 sessions after their complete tumor removal, while the other group undergoes complete resection alone without further treatment. This open-label, multi-center trial compares these approaches to assess their impact on survival. Throughout the study, participants will be monitored for disease-free survival over five years as the main outcome. Secondary measures include overall survival and tracking any treatment-related side effects using standard criteria. Patients will undergo regular follow-ups and evaluations to assess their health status and treatment effects during this period, which lasts up to five years after enrollment.

Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection