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Studies

Interventional Recruiting

NCT04731610 on ClinicalTrials.gov

Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma (RADIO-RYTHMIC-01)

Official title: Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma

  • Sponsor: Institut Curie
  • Enrollment: 314 (Estimated)
  • Study start: 2021-12-28 (Actual)
  • Primary completion: 2031-12-28 (Estimated)
  • Study completion: 2032-12-28 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

The primary objective of the study : to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.

Conditions

  • Thymoma Malignant Recurrent

Intervention / Treatment

  • Other: Radiotherapy
  • Other: Surveillance after resection

Primary Outcome Measures

  • Recurrence-Free survival (RFS) (3 years)
    to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.

Countries

France

Locations and Investigators

  • CHU Caen, Caen, France (Recruiting)
    • Simon DESHAYES, MD
    • Simon DESHAYES, MD (Principal Investigator)
  • CLCC François BACLESSE, Caen, France (Recruiting)
    • Delphine LEROUGE, MD
    • Delphine LEROUGE, MD (Principal Investigator)
  • CLCC Georges François Leclerc, Dijon, France (Recruiting)
    • Etienne MARTIN, MD
    • Etienne MARTIN, MD (Principal Investigator)
  • Centre Oscar Lambret, Lille, France (Recruiting)
  • CHU Lyon, Lyon, France (Recruiting)
    • Thomas PIERRET, MD
    • Thomas PIERRET, MD (Principal Investigator)
  • AP-HM Hôpital Nord, Marseille, France (Recruiting)
  • Institut du Cancer de Montpellier, Montpellier, France (Not yet recruiting)
    • Xavier QUANTIN, Pr
    • Xavier QUANTIN, Pr (Principal Investigator)
  • Antoine LACASSAGNE, Nice, France (Not yet recruiting)
    • Jérôme DOYEN, MD
    • Jérôme DOYEN, MD (Principal Investigator)
  • Institut Curie, Paris, France (Recruiting)
    • Nicolas GIRARD, PR
    • Nicolas GIRARD, PR (Principal Investigator)
  • Hôpital Européen Georges Pompidou, Paris, France (Not yet recruiting)
    • Aurélia ALATI, MD
    • Aurélia ALATI, MD (Principal Investigator)
  • Hôpital Bichat AP-HP, Paris, France (Recruiting)
    • Valérie GOUNANT, Pr
    • Valérie GOUNANT, Pr (Principal Investigator)
  • CHU Haut Lévêque, Pessac, France (Not yet recruiting)
    • POUYPOUDAT, MD
    • Claudia POUYPOUDAT, MD (Principal Investigator)
  • CHU Rennes Hôpital Sud, Rennes, France (Recruiting)
    • Charles RICORDEL, MD
    • Charles RICORDEL, MD (Principal Investigator)
  • CHU Rouen, Rouen, France (Withdrawn)
  • CLCC Henri Becquerel, Rouen, France (Not yet recruiting)
  • Institut de Cancérologie de l'Ouest, Saint-Herblain, France (Recruiting)
    • François THILLAYS, MD
    • François THILLAYS, Pr (Principal Investigator)
  • CHU Strasbourg, Strasbourg, France (Not yet recruiting)
  • Institut Claudius Regaud, Toulouse, France (Recruiting)
    • Jonathan KHALIFA, MD
    • Jonathan KHALIFA, MD (Principal Investigator)
  • CHRU Tours, Tours, France (Recruiting)
    • Eric PICHON, MD
    • Eric PICHON, MD (Principal Investigator)
  • Institut de Cancérologie de Lorraine Nancy, VandÅ“uvre-lès-Nancy, France (Recruiting)
    • Mathilde CUENIN, MD
    • Mathilde CUENIN, MD (Principal Investigator)
  • Gustave Roussy, Villejuif, France (Recruiting)
    • Angela BOTTICELLA, MD
    • Angela BOTTICELLA, MD (Principal Investigator)