1. RADIORYTHMIC: Phase III, Opened, Randomized Study of Postoperative Radiotherapy Versus Surveillance in Stage IIb/III of Masaoka Koga Thymoma after Complete Surgical Resection
- Author
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Xavier Quantin, Nicolas Girard, Marylise Ginoux, Luc Thiberville, Benjamin Besse, Christelle Clément-Duchêne, P.A. Thomas, P. Mordant, Angela Botticella, C. Le Pechoux, J. Khalifa, Eric Pichon, Thierry Jo Molina, F. Le Tinier, Youssef Oulkhouir, Mallorie Kerjouan, Clémence Basse, Pierre Emmanuel Falcoz, F. Thillays, Virginie Westeel, Equipe Quantification en Imagerie Fonctionnelle (QuantIF-LITIS), Laboratoire d'Informatique, de Traitement de l'Information et des Systèmes (LITIS), Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Université Le Havre Normandie (ULH), Normandie Université (NU)-Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), and Normandie Université (NU)
- Subjects
Adult ,0301 basic medicine ,Pulmonary and Respiratory Medicine ,Cancer Research ,medicine.medical_specialty ,Thymoma ,Adolescent ,[SDV]Life Sciences [q-bio] ,medicine.medical_treatment ,Network ,law.invention ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,hemic and lymphatic diseases ,medicine ,Clinical endpoint ,Humans ,Postoperative Period ,Postoperative radiotherapy ,Stage (cooking) ,Lung cancer ,Aged ,Neoplasm Staging ,Retrospective Studies ,Surveillance ,business.industry ,Mediastinum ,Retrospective cohort study ,Thymus Neoplasms ,Middle Aged ,Prognosis ,medicine.disease ,3. Good health ,Radiation therapy ,030104 developmental biology ,medicine.anatomical_structure ,Oncology ,030220 oncology & carcinogenesis ,Surgery ,Radiology ,business - Abstract
Introduction Thymomas are rare intrathoracic malignancies that may be aggressive and difficult to treat. Knowledge and level of evidence for treatment strategies are mainly based on retrospective studies or expert opinion. Currently there is no strong evidence that postoperative radiotherapy after complete resection of localized thymoma is associated with survival benefit in patients. RADIORYTHMIC is a phase III, randomized trial aiming at comparing postoperative radiotherapy versus surveillance after complete resection of Masaoka-Koga stage IIb/III thymoma. Systematic central pathologic review will be performed before patient enrollment as per the RYTHMIC network pathway. Patients and Methods Three hundred fourteen patients will be included; randomization 1:1 will attribute either postoperative radiotherapy (50-54 Gy to the mediastinum using intensity-modulated radiation therapy or proton beam therapy) or surveillance. Stratification criteria include histologic grading (thymoma type A, AB, B1 vs B2, B3), stage, and delivery of preoperative chemotherapy. Patient recruitment will be mainly made through the French RYTHMIC network of 15 expert centers participating in a nationwide multidisciplinary tumor board. Follow-up will last 7 years. The primary endpoint is recurrence-free survival. Secondary objectives include overall survival, assessment of acute and late toxicities, and analysis of prognostic and predictive biomarkers. Results The first patient will be enrolled in January 2021, with results expected in 2028.
- Published
- 2021
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