OncoMatch/Clinical Trials/NCT05529251
De-escalation Study for Stage IIa/IIb < 3 cm Seminoma
Is NCT05529251 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Carboplatin AUC7 and 3 cycles of EP for seminoma.
Treatment: Carboplatin AUC7 · 3 cycles of EP — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Testicular Germ Cell Tumor
Disease stage
Required: Stage IIA, IIB
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: radiotherapy
No prior treatment with radiotherapy
Cannot have received: chemotherapy
No prior treatment with chemotherapy
Lab requirements
Blood counts
Neutrophils ≥ 1.5 x Giga/l, platelets ≥ 100 x Giga/l
Kidney function
Serum creatinine < 140 µmol/l OR calculated clearance > 60 ml/min (using either Cockcroft-Gault formula or MDRD for > 65 years old)
Liver function
AST and ALT ≤ 1.5 x ULN; Direct and total bilirubin ≤ ULN
Adequate bone-marrow, hepatic, and renal functions with: Neutrophils ≥ 1.5 x Giga/l, platelets ≥ 100 x Giga/l, AST and ALT ≤ 1.5 x ULN, Serum creatinine < 140 µmol/l OR calculated clearance > 60 ml/min, Direct and total bilirubin ≤ ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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