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

Last updated: April 17, 2026
Sponsor: Institut Curie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

Radiotherapy

Surveillance after resection

Clinical Study ID

NCT04731610
IC 2020-09
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 < Age < 75 years old

  2. ECOG performance status ≤1

  3. Preoperative chemotherapy is allowed. Maximum of 4 cycles are authorized. Surgeryshould be realized ≤ 2 months after the last chemotherapy injection.

  4. Histologically diagnosed thymoma at pathological examination of surgical specimenafter pathological review; for note, centralized, real-time, systematic pathologicalreview is standard through the RYTHMIC network in France

  5. Complete resection at pathological examination of the surgical specimen aftersurgery conducted through standard, recommended approach ensuring accurateassessment of resection status

  6. Stage IIb or III disease according to the Masaoka-Koga staging system; thiscorresponds to stage pT1a with capsule invasion, until stage pT3 N0 M0 in the 8thTNM staging system TNM UICC/AJCC

  7. Availability of thoracic Computed-Tomography (CT) scan with IV contrast (in theabsence of contra-indications) or PET scan performed before surgery

  8. Availability of a thoracic Computed-Tomography (CT) scan with IV contrast (in theabsence of contra-indications) showing absence of residual disease after surgicalresection of the tumor

  9. Pulmonary function tests after surgery with FEV1 ≥ 1L or ≥ 35% of the theoreticalvalue and DLCO ≥ 40%

  10. Signature of informed consent form

Exclusion

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.
  1. 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 Design

Total Participants: 314
Treatment Group(s): 2
Primary Treatment: Radiotherapy
Phase:
Study Start date:
December 28, 2021
Estimated Completion Date:
December 28, 2032

Connect with a study center

  • Institut de Cancérologie de l'Ouest Angers

    Angers, 44805
    France

    Site Not Available

  • CHU Caen

    Caen, 14000
    France

    Active - Recruiting

  • CLCC François BACLESSE

    Caen, 14000
    France

    Active - Recruiting

  • CHU Caen

    Caen 3029241, 14000
    France

    Site Not Available

  • CLCC François BACLESSE

    Caen 3029241, 14000
    France

    Active - Recruiting

  • CLCC Georges François Leclerc

    Dijon, 21079
    France

    Active - Recruiting

  • CLCC Georges François Leclerc

    Dijon 3021372, 21079
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille, 59000
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille 2998324, 59000
    France

    Site Not Available

  • CHU Lyon

    Lyon, 69002
    France

    Active - Recruiting

  • CHU Lyon

    Lyon 2996944, 69002
    France

    Site Not Available

  • AP-HM Hôpital Nord

    Marseille, 13005
    France

    Active - Recruiting

  • AP-HM Hôpital Nord

    Marseille 2995469, 13005
    France

    Site Not Available

  • Institut du Cancer de Montpellier

    Montpellier, 34090
    France

    Site Not Available

  • Institut du Cancer de Montpellier

    Montpellier 2992166, 34090
    France

    Site Not Available

  • Antoine LACASSAGNE

    Nice, 06189
    France

    Site Not Available

  • Hôpital Bichat AP-HP

    Paris, 75018
    France

    Active - Recruiting

  • Hôpital Européen Georges Pompidou

    Paris, 75015
    France

    Site Not Available

  • Institut Curie

    Paris, 75005
    France

    Active - Recruiting

  • Hôpital Bichat AP-HP

    Paris 2988507, 75018
    France

    Active - Recruiting

  • Hôpital Européen Georges Pompidou

    Paris 2988507, 75015
    France

    Site Not Available

  • Institut Curie

    Paris 2988507, 75005
    France

    Site Not Available

  • CHU Haut Lévêque

    Pessac, 33604 Cedex
    France

    Site Not Available

  • CHU Haut Lévêque

    Pessac 2987805, 33604 Cedex
    France

    Site Not Available

  • CHU Rennes Hôpital Sud

    Rennes, 35056
    France

    Active - Recruiting

  • CHU Rennes Hôpital Sud

    Rennes 2983990, 35056
    France

    Site Not Available

  • CHU Rouen

    Rouen,
    France

    Site Not Available

  • CLCC Henri Becquerel

    Rouen,
    France

    Site Not Available

  • CHU Rouen

    Rouen 2982652,
    France

    Site Not Available

  • CLCC Henri Becquerel

    Rouen 2982652,
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805
    France

    Active - Recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain 2979590, 44805
    France

    Site Not Available

  • CHU Strasbourg

    Strasbourg, 67098
    France

    Site Not Available

  • CHU Strasbourg

    Strasbourg 2973783, 67098
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31300
    France

    Active - Recruiting

  • Institut Claudius Regaud

    Toulouse 2972315, 31300
    France

    Site Not Available

  • CHRU Tours

    Tours, 37044
    France

    Active - Recruiting

  • CHRU Tours

    Tours 2972191, 37044
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine Nancy

    Vandœuvre-lès-Nancy, 54519
    France

    Active - Recruiting

  • Institut de Cancérologie de Lorraine Nancy

    Vandœuvre-lès-Nancy 2970797, 54519
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94800
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif 2968705, 94800
    France

    Site Not Available

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