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

NCT ID: NCT04731610

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-28

Study Completion Date

2032-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Thymoma Malignant Recurrent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Post-operative radiotherapy

Tumour resection followed by radiotherapy.

Group Type OTHER

Radiotherapy

Intervention Type OTHER

postoperative radiotherapy after complete resection of thymoma

Surveillance after tumour resection

Tumour resection

Group Type OTHER

Surveillance after resection

Intervention Type OTHER

Surveillance after tumour resection

Interventions

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Radiotherapy

postoperative radiotherapy after complete resection of thymoma

Intervention Type OTHER

Surveillance after resection

Surveillance after tumour resection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Caen

Caen, , France

Site Status RECRUITING

CLCC François BACLESSE

Caen, , France

Site Status RECRUITING

CLCC Georges François Leclerc

Dijon, , France

Site Status RECRUITING

Centre Oscar Lambret

Lille, , France

Site Status RECRUITING

CHU Lyon

Lyon, , France

Site Status RECRUITING

AP-HM Hôpital Nord

Marseille, , France

Site Status RECRUITING

Institut du Cancer de Montpellier

Montpellier, , France

Site Status NOT_YET_RECRUITING

Institut Curie

Paris, , France

Site Status RECRUITING

Hôpital Européen Georges Pompidou

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital Bichat AP-HP

Paris, , France

Site Status RECRUITING

CHU Haut Lévêque

Pessac, , France

Site Status NOT_YET_RECRUITING

CHU Rennes Hôpital Sud

Rennes, , France

Site Status RECRUITING

CHU Rouen

Rouen, , France

Site Status WITHDRAWN

CLCC Henri Becquerel

Rouen, , France

Site Status NOT_YET_RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, , France

Site Status RECRUITING

CHU Strasbourg

Strasbourg, , France

Site Status NOT_YET_RECRUITING

Institut Claudius Regaud

Toulouse, , France

Site Status RECRUITING

CHRU Tours

Tours, , France

Site Status RECRUITING

Institut de Cancérologie de Lorraine Nancy

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nicolas GIRARD, PR

Role: CONTACT

Phone: (0)1 44 32 46 06

Email: [email protected]

Facility Contacts

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Simon DESHAYES, MD

Role: primary

Delphine LEROUGE, MD

Role: primary

Etienne MARTIN, MD

Role: primary

Florence LE TINIER, MD

Role: primary

Thomas PIERRET, MD

Role: primary

Pascal THOMAS, Pr

Role: primary

Xavier QUANTIN, Pr

Role: primary

Nicolas GIRARD, PR

Role: primary

Aurélia ALATI, MD

Role: primary

Valérie GOUNANT, Pr

Role: primary

POUYPOUDAT, MD

Role: primary

Charles RICORDEL, MD

Role: primary

Sébastien THUREAU, MD

Role: primary

François THILLAYS, MD

Role: primary

Pierre-Emmanuel FALCOZ, Pr

Role: primary

Jonathan KHALIFA, MD

Role: primary

Eric PICHON, MD

Role: primary

Mathilde CUENIN, MD

Role: primary

Angela BOTTICELLA, MD

Role: primary

Other Identifiers

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IC 2020-09

Identifier Type: -

Identifier Source: org_study_id