About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years on the day of signing informed consent.
Primary testicular seminomatous germ cell tumor.
Stage IIa/IIb < 3 cm in largest diameter seminoma, histologically proved after orchiectomy.
Confirmation of a progressive disease (positive PET scan or increase of lymph nodes size by two successive CT scan).
Disqualifiers
Extra-retroperitoneal metastasis on Computed tomography scan (CT scan).
Infection by Human Immunodeficiency Virus (HIV), or active infection with the Hepatitis B or C virus.
History, within 2 years, of cancer other than seminoma, except for treated skin cancer (basal cell).
Uncontrolled or severe cardiovascular pathology.
Trial design
Treatments tested in this trial
- Radiotherapy boost
- Carboplatin AUC7
- 3 cycles of EP