De-escalation Study for Stage IIa/IIb < 3 cm Seminoma
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.
Timeline
- Start
- 2022-09-06
- Primary completion
- 2025-09-06
- Completion
- 2030-09-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Etoposide | Small molecule | — | — |