Testicular seminoma (pure) stage I Trials in Disease

Study Comparing Chemotherapy Options for Patients with Stage I Testicular Cancer: Bleomycin, Etoposide, Cisplatin vs. Carboplatin

This clinical trial is investigating the best chemotherapy approach for men diagnosed with seminomatous testicular cancer at stage I, meaning the cancer has not spread beyond the testicle. The study compares two different treatment strategies to reduce the risk of cancer returning after the affected testicle has been surgically removed.

Main inclusion criteria:

• Confirmed diagnosis of seminoma testicular cancer on one side only, at clinical stage I
• The tumor must be larger than 4 cm or have invaded the rete testis (a structure within the testicle)
• Normal levels of AFP (alpha-fetoprotein) before surgery
• Age between 18 and 59 years old
• ECOG performance status of 0, 1, or 2, which measures how well you can perform daily activities
• Normal organ function, including adequate liver function, kidney function (GFR greater than 50 ml/min), and blood cell counts
• Agreement to use effective birth control for 6 months after treatment if fertile
• Ability to provide written informed consent

Main exclusion criteria:

• Female patients cannot participate
• Patients without testicular cancer cannot participate
• Patients who belong to vulnerable populations with limited ability to protect their own interests

Trial focus and goal:

The main goal of this study is to determine whether one course of BEP chemotherapy (a combination of three drugs) results in a lower chance of cancer returning compared to one course of Carboplatin (a single drug). Participants will be randomly assigned to receive either the BEP combination or Carboplatin, both given intravenously. Researchers will monitor patients over time to evaluate how well each treatment works, assess any side effects, and measure the impact on quality of life. The study will track relapse rates, short-term and long-term side effects, overall survival, and will also include an economic analysis of the healthcare costs involved. The trial is expected to continue until the end of 2032.

Investigational drugs being tested:

• Bleomycin: A medication that interferes with cancer cell growth by causing breaks in DNA strands, preventing cancer cells from dividing
• Etoposide: A chemotherapy drug that stops cancer cells from growing by inhibiting an enzyme essential for DNA replication
• Cisplatin: A platinum-based chemotherapy drug that kills cancer cells by damaging their DNA and preventing cell division
• Carboplatin: Similar to cisplatin, this platinum-based drug prevents cancer cells from growing by interfering with their DNA

All medications are administered through intravenous infusion. The BEP group receives all three drugs (bleomycin, etoposide, and cisplatin) together, while the carboplatin group receives only carboplatin. Regular follow-up visits are scheduled to monitor treatment effectiveness and patient wellbeing throughout the study period.