Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) Versus Carboplatin in Stage I Seminomatous Testicular Cancer

Ki vehet részt

• Histological diagnosis of unilateral seminoma testicular cancer, evaluating both size of tumor and invasion of the rete testis
• Clinical stage I
• Tumor size over 4 cm and/or stromal invasion of the rete testis by tumor cells
• Normal value of alpha-fetoprotein (AFP) before orchiectomy. A stable, slightly elevated AFP as a normal value may be permitted
• Age ≥ 18 years and < 60 years
• Adequate organ function defined as:; Serum aspartate transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN). Total serum bilirubin ≤ 1.5 x ULN Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L Creatinine clearance > 50 ml/min (eGFR) All fertile patients should use safe contraception Written informed consent

Ki nem vehet részt

• Prior diagnosis of testicular cancer
• Serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
• Signs of metastatic disease evaluated by CT thorax, abdomen and pelvis. Patients in need of restaging (see SWENOTECA IX) should not be included
• Chronic pulmonary disorders giving a high risk of bleomycin induced toxicity (for example chronic obstructive pulmonary disease or lung fibrosis)
• Cancer other than seminoma testicular cancer
• Known hypersensitivity or contraindications for the study drugs
• Medical, social, psychological conditions that could prevent adequate information and follow-up