Clinical Trial

De-escalation Study for Stage IIa/IIb < 3 cm Seminoma

Study acronym: EDEN
Recruiting Phase 2
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Record status
This record was last updated January 25, 2024 (before its estimated September 6, 2025 completion). Its status may not reflect the trial's current state.
Summary
Phase II, multicenter, prospective, randomized, non-comparative, de-escalation study. Patients with stage IIa/IIb \< 3 cm seminoma histologically proved after orchiectomy will be included in the study and will receive 1 cycle of Etoposide Cisplatine (EP) chemotherapy. Patients with negative week-3 PET-scan after the EP cycle, will be randomized (1:1 ratio, stratification according to the disease stage (stage IIa versus IIb seminoma)) to receive either radiotherapy (RT) boost on lymph nodes or 1 cycle of carboplatin AUC7 chemotherapy. Patients with positive week-3 PET-scan will received 3 additional cycles of EP chemotherapy. In parallel, eligible patients scheduled to receive standard lombo-aortic RT will be registered in an observational cohort.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-09-01; most recent amendment 2024-01-24.
Status change: Not Yet Recruiting → Recruiting 2022-12-05
Trial Details
NCT Number NCT05529251
Lead Sponsor Centre Leon Berard
Conditions Seminoma, Stage II
Enrollment 90 participants
Start Date 2022-09-06
Primary Completion 2025-09-06 (estimated)
Study Completion 2030-09-06 (estimated)
Updated on ClinicalTrials.gov 2024-01-25