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

What this trial studies

Short term overall survival is, regardless of treatment allocation, expected to be very close to 100 %. The primary outcome is relapse rate. The power of the study depends on the number of observed relapses. If the relapse rate in the adjuvant carboplatin group, the reference group, is lower than the anticipated 9 %, we need to include more patients to the study. Based on all previous published material on adjuvant treatment in clinical stage I seminoma it is not possible to precisely estimate the correct relapse rate until the median follow-up is four years. Consequently, we will estimate the relapse rate in the reference group close to the end of accrual. If the estimated relapse rate, and thus the number of relapses, is lower than the anticipated we will increase the sample size to make sure that the study meets the minimum required number of relapses in the reference group. A possible inclusion of more study participants does not compromise the Type I error rate of the study.

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Signs of metastatic disease evaluated by CT thorax, abdomen and pelvis. Patients in need of restaging (see SWENOTECA IX) should not be included
* Prior diagnosis of testicular cancer
* 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
* 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
* Medical, social, psychological conditions that could prevent adequate information and follow-up

Where it's running

• Institutt for kreftforskning og molekylær medisin, St Olavs Hospital
  Trondheim, Norway
• St. Olavs University hospital HF
  Trondheim, Norway

Study contacts

• Principal investigator: Olof Ståhl, Md PhD — Skane University Hospital

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.