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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Thymoma Malignant Recurrent
• Intervention / Treatment: Other: Radiotherapy; Other: Surveillance after resection

• Study Type: Interventional
• Enrollment (Estimated): 314
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas GIRARD, PR; Phone Number: +33 (0)1 44 32 46 06; Email: nicolas.girard2@curie.fr

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • CHU caen
    • Contact: Simon DESHAYES, MD
    • Principal Investigator: Simon DESHAYES, MD
  • Caen, France, 14000
    • Recruiting
    • CLCC François BACLESSE
    • Contact: Delphine LEROUGE, MD
    • Principal Investigator: Delphine LEROUGE, MD
  • Dijon, France, 21079
    • Recruiting
    • Clcc Georges Francois Leclerc
    • Principal Investigator: Etienne MARTIN, MD
    • Contact: Etienne MARTIN, MD
  • Lille, France, 59000
    • Recruiting
    • Centre Oscar Lambret
    • Principal Investigator: Florence LE TINIER, MD
    • Contact: Florence LE TINIER, MD
  • Lyon, France, 69002
    • Recruiting
    • CHU Lyon
    • Contact: Thomas PIERRET, MD
    • Principal Investigator: Thomas PIERRET, MD
  • Marseille, France, 13005
    • Recruiting
    • AP-HM Hopital Nord
    • Contact: Pascal THOMAS, Pr
    • Principal Investigator: Pascal THOMAS, Pr
  • Montpellier, France, 34090
    • Not yet recruiting
    • Institut du Cancer de Montpellier
    • Contact: Xavier QUANTIN, Pr
    • Principal Investigator: Xavier QUANTIN, Pr
  • Nice, France, 06189
    • Not yet recruiting
    • Antoine LACASSAGNE
    • Contact: Jérôme DOYEN, MD
    • Principal Investigator: Jérôme DOYEN, MD
  • Paris, France, 75015
    • Not yet recruiting
    • Hôpital Européen Georges Pompidou
    • Contact: Aurélia ALATI, MD
    • Principal Investigator: Aurélia ALATI, MD
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
    • Contact: Nicolas GIRARD, PR; Email: nicolas.girard2@curie.fr
    • Principal Investigator: Nicolas GIRARD, PR
  • Paris, France, 75018
    • Recruiting
    • Hôpital Bichat AP-HP
    • Contact: Valérie GOUNANT, Pr
    • Principal Investigator: Valérie GOUNANT, Pr
  • Pessac, France, 33604 Cedex
    • Not yet recruiting
    • CHU Haut Lévêque
    • Contact: POUYPOUDAT, MD
    • Principal Investigator: Claudia POUYPOUDAT, MD
  • Rennes, France, 35056
    • Recruiting
    • CHU Rennes Hôpital Sud
    • Contact: Charles RICORDEL, MD
    • Principal Investigator: Charles RICORDEL, MD
  • Rouen, France
    • Withdrawn
    • CHU Rouen
  • Rouen, France
    • Not yet recruiting
    • CLCC Henri Becquerel
    • Contact: Sébastien THUREAU, MD
    • Principal Investigator: Sébastien THUREAU, MD
  • Saint-Herblain, France, 44805
    • Recruiting
    • Institut de cancerologie de l'ouest
    • Contact: François THILLAYS, MD
    • Principal Investigator: François THILLAYS, Pr
  • Strasbourg, France, 67098
    • Not yet recruiting
    • CHU Strasbourg
    • Contact: Pierre-Emmanuel FALCOZ, Pr
    • Principal Investigator: Pierre-Emmanuel FALCOZ, Pr
  • Toulouse, France, 31300
    • Recruiting
    • Institut Claudius Regaud
    • Contact: Jonathan KHALIFA, MD
    • Principal Investigator: Jonathan KHALIFA, MD
  • Tours, France, 37044
    • Recruiting
    • CHRU Tours
    • Contact: Eric PICHON, MD
    • Principal Investigator: Eric PICHON, MD
  • Vandœuvre-lès-Nancy, France, 54519
    • Recruiting
    • Institut de Cancérologie de Lorraine Nancy
    • Contact: Mathilde CUENIN, MD
    • Principal Investigator: Mathilde CUENIN, MD
  • Villejuif, France, 94800
    • Recruiting
    • Gustave Roussy
    • Contact: Angela BOTTICELLA, MD
    • Principal Investigator: Angela BOTTICELLA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 < Age < 75 years old
2. ECOG performance status ≤1
3. Preoperative chemotherapy is allowed. Maximum of 4 cycles are authorized. Surgery should be realized ≤ 2 months after the last chemotherapy injection.
4. Histologically diagnosed thymoma at pathological examination of surgical specimen after pathological review; for note, centralized, real-time, systematic pathological review is standard through the RYTHMIC network in France
5. Complete resection at pathological examination of the surgical specimen after surgery conducted through standard, recommended approach ensuring accurate assessment of resection status
6. Stage IIb or III disease according to the Masaoka-Koga staging system; this corresponds to stage pT1a with capsule invasion, until stage pT3 N0 M0 in the 8th TNM staging system TNM UICC/AJCC
7. Availability of thoracic Computed-Tomography (CT) scan with IV contrast (in the absence of contra-indications) or PET scan performed before surgery
8. Availability of a thoracic Computed-Tomography (CT) scan with IV contrast (in the absence of contra-indications) showing absence of residual disease after surgical resection of the tumor
9. Pulmonary function tests after surgery with FEV1 ≥ 1L or ≥ 35% of the theoretical value and DLCO ≥ 40%
10. Signature of informed consent form

Exclusion Criteria:

- 1. Age > 75 years old 2. Histology of thymic carcinoma 3. Delivery of post-operative chemotherapy, concurrent chemotherapy to radiotherapy 4. Presence of microscopic or macroscopic residual tumor after surgery or metastases (R1 or R2 resection) 5. Uncontrolled, clinically significant pleural or pericardial effusion 6. Patients with prior radiation therapy to the thorax. Patients treated with conformal radiotherapy for prior breast or head and neck neoplasms should be discussed with PI 7. Evidence of severe or uncontrolled systemic disease as judged by the investigator 8. Recent (< 6 months) severe cardiac disease (uncontrolled arrhythmia, congestive heart failure, infarction, pace-maker) or pulmonary disease. Controlled and non clinically symptomatic arrhythmia is allowed.

9. Current or past history of neoplasm diagnosed within the last 3 years, except: basal cell carcinoma of the skin, in situ carcinoma of the cervix, and bladder in situ. A patient diagnosed for another neoplasm 3 years ago or more, treated and considered as cured may be included in the study if all the other criteria are respected 10. Pregnancy or breast feeding or inadequate contraceptive measures for women of childbearing potential during PORT 11. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls, 12. Patients deprived of freedom or under guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Post-operative radiotherapy; Tumour resection followed by radiotherapy.	Other: Radiotherapy; postoperative radiotherapy after complete resection of thymoma
Other: Surveillance after tumour resection; Tumour resection	Other: Surveillance after resection; Surveillance after tumour resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-Free survival (RFS)	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local-regional (pleural or pericardial) recurrence	Local-regional (pleural or pericardial) recurrence; location of recurrence /removed	3 years

Collaborators and Investigators

• Sponsor: Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Estimated): December 28, 2031
• Study Completion (Estimated): December 28, 2032

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Thoracic Neoplasms; Lymphatic Diseases; Neoplasms, Complex and Mixed; Thymus Neoplasms; Thymoma; Therapeutics; Radiotherapy
• Other Study ID Numbers: IC 2020-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets . Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No