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

NCT04731610 | Recruiting

• 1 other identifier: IC 2020-09
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 21

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Local-regional (pleural or pericardial) recurrence

  3 years

Study Arms (2)

Post-operative radiotherapy

OTHER

Tumour resection followed by radiotherapy.

Other: Radiotherapy

Surveillance after tumour resection

OTHER

Tumour resection

Other: Surveillance after resection

Interventions

Surveillance after resection OTHER

Surveillance after tumour resection

Surveillance after tumour resection

Radiotherapy OTHER

postoperative radiotherapy after complete resection of thymoma

Post-operative radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \< Age \< 75 years old
• ECOG performance status ≤1
• Preoperative chemotherapy is allowed. Maximum of 4 cycles are authorized. Surgery should be realized ≤ 2 months after the last chemotherapy injection.
• 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
• Complete resection at pathological examination of the surgical specimen after surgery conducted through standard, recommended approach ensuring accurate assessment of resection status
• 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
• Availability of thoracic Computed-Tomography (CT) scan with IV contrast (in the absence of contra-indications) or PET scan performed before surgery
• 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
• Pulmonary function tests after surgery with FEV1 ≥ 1L or ≥ 35% of the theoretical value and DLCO ≥ 40%
• Signature of informed consent form

You may not qualify if:

• \- 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.
• \. 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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (21)

CHU Caen

Caen, 14000, France

RECRUITING

CLCC François BACLESSE

Caen, 14000, France

RECRUITING

CLCC Georges François Leclerc

Dijon, 21079, France

RECRUITING

Centre Oscar Lambret

Lille, 59000, France

RECRUITING

CHU Lyon

Lyon, 69002, France

RECRUITING

AP-HM Hôpital Nord

Marseille, 13005, France

RECRUITING

Institut du Cancer de Montpellier

Montpellier, 34090, France

NOT YET RECRUITING

Antoine LACASSAGNE

Nice, 06189, France

NOT YET RECRUITING

Institut Curie

Paris, 75005, France

RECRUITING

Hôpital Européen Georges Pompidou

Paris, 75015, France

NOT YET RECRUITING

Hôpital Bichat AP-HP

Paris, 75018, France

RECRUITING

CHU Haut Lévêque

Pessac, 33604 Cedex, France

NOT YET RECRUITING

CHU Rennes Hôpital Sud

Rennes, 35056, France

RECRUITING

CHU Rouen

Rouen, France

WITHDRAWN

CLCC Henri Becquerel

Rouen, France

NOT YET RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

RECRUITING

CHU Strasbourg

Strasbourg, 67098, France

NOT YET RECRUITING

Institut Claudius Regaud

Toulouse, 31300, France

RECRUITING

CHRU Tours

Tours, 37044, France

RECRUITING

Institut de Cancérologie de Lorraine Nancy

Vandœuvre-lès-Nancy, 54519, France

RECRUITING

Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Nicolas GIRARD, PR

CONTACT

(0)1 44 32 46 06; nicolas.girard2@curie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 1, 2021
• Study Start: December 28, 2021
• Primary Completion (Estimated): December 28, 2031
• Study Completion (Estimated): December 28, 2032
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• 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).

Locations

FR (21)