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

ConditionThymoma Malignant Recurrent

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorInstitut Curie

About this trial

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

Qualifiers

18 < 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

Disqualifiers

None

Trial design

Treatments tested in this trial

Radiotherapy
Surveillance after resection

Treatment groups

314 Participants

are divided into 2 treatment groups

Locations21

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Sponsors and collaborators

Institut Curie

Lead sponsor

Source ClinicalTrials.gov