Therapy De-escalation in Seminoma Stage IIA/B

Inclusion Criteria:

• Patient has given written informed consent before registration.
• Histologically confirmed classical seminoma treated with primary inguinal orchidectomy 12 weeks or less before registration.
• Tumor stage is pT1-4 cN1-2 cM0 according to UICC TNM 2009.
• Multi-slice CT of the chest, abdomen and pelvis or a FDG-PET-CT within 4 weeks prior to patient registration, showing stage IIA/B disease. Oral and i.v. contrast have to be administered.
• Age ≥ 18 years.
• WHO performance status 0-2.
• Adequate hematological values: neutrophils ≥ 1.0 x 109/L, platelets ≥ 100x 109/L.
• Adequate renal function (calculated creatinine clearance ≥ 50 ml/min, according to the formula of Cockcroft-Gault).
• Patient agrees not to father a child during trial treatment and during 12 months thereafter.
• Patient has been proposed sperm conservation.
• Patient compliance and geographic proximity allow proper staging and follow-up for at least 3 years.

Exclusion Criteria:

• Previous or concurrent malignancy within 5 years with the exception of localized non-melanoma skin cancer.
• Psychiatric disorder precluding understanding of information on trial-related topics or giving informed consent or interfering with compliance for treatment schedule.
• Mixed histology seminoma.
• Elevated levels of AFP (≥ULN).
• Any prior abdominal/pelvic radiotherapy (RT).
• Any anti-cancer therapy after primary tumor resection.
• Any treatment in a clinical trial within 30 days of trial entry.
• Any serious underlying medical condition or serious co-morbidity (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial.
• Any contraindication for the trial drug (for example, known hypersensitivity to trial drug or to any other co-component of the trial drug, past or current renal insufficiency, severe hepatic insufficiency, severe bone marrow dysfunction, tumor bleeding, major hearing defects).
• Any concomitant drugs contraindicated for use with the trial drug according to the approved product information (for example, nephrotoxic or ototoxic medicines).