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

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy

    Other intervention

    postoperative radiotherapy after complete resection of thymoma

  • Surveillance after resection

    Other intervention

    Surveillance after tumour resection

Treatment groups

314 Participants
are divided into 2 treatment groups
Group A: Post-operative radiotherapyOther 1 intervention
Group B: Surveillance after tumour resectionOther 1 intervention

Trial outcomes

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.

Time frame
3 years

Secondary outcomes

1

Local-regional (pleural or pericardial) recurrence

Local-regional (pleural or pericardial) recurrence; location of recurrence /removed

Time frame
3 years

Other outcomes

Sponsors and contacts

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