De-escalation Study for Stage IIa/IIb < 3 cm Seminoma
Status:
Not yet recruiting
Trial end date:
2030-09-06
Target enrollment:
Participant gender:
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.