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

Study acronym: EDEN
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 years 7 months later Sep 6, 2025 → May 4, 2032
See other at-risk trials from Centre Leon Berard

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 6, 2025 to May 4, 2032 Show 5 more changesShow less
    • Study completion pushed from Sep 6, 2030 to May 4, 2032
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised at 4 of 15 sites
    • Study description expanded, about 2 words
  2. Site details revised at 10 of 15 sitesv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 15 of 15 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05529251
Lead Sponsor Centre Leon Berard
Conditions
(from sponsor)		 Seminoma, Stage II
Related terms Seminoma
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov