RADIO-RYTHMIC
RADIORYTHMIC: Phase III, Opened, Randomized Study of Postoperative Radiotherapy Versus Surveillance in Stage IIb/III of Masaoka Koga Thymoma after Complete Surgical Resection
Phase 3N = 314NCT04731610
- Population
- Patients with Masaoka-Koga stage IIb or III thymoma after complete surgical resection (planned 314)
- Design
- Randomised phase 3 trial (design paper; no results published in the paper). 314 patients are planned, randomised 1:1 to postoperative radiotherapy (50-54 Gy to the mediastinum with intensity-modulated radiation therapy or proton beam therapy) or surveillance, stratified by histologic grading, stage and delivery of preoperative chemotherapy; central pathologic review before enrolment; recruitment mainly through the French RYTHMIC network of 15 expert centres; follow-up 7 years. The primary end point is recurrence-free survival; secondary objectives include OS, acute and late toxicity, and prognostic and predictive biomarkers. The design paper expected the first patient in January 2021 and results in 2028. The ClinicalTrials.gov record (NCT04731610, sponsor Institut Curie) lists the study as recruiting (status verified April 2026), with an actual start of 28 December 2021, an estimated primary completion of December 2031, phase 'NA' and a 3-year time frame for the primary outcome; the paper and the registry differ on these points and both are shown as published.
- Primary endpoint
- RFS
- Arms
- Surveillance (control): Surveillance after complete resection, no radiotherapy
- Postoperative radiotherapy (experimental): 50-54 Gy to the mediastinum using intensity-modulated radiation therapy or proton beam therapy
- People
- Basse C, senior author Girard N, RYTHMIC network (France)