Phase III Randomized Trial Comparing Adjuvant Bleomycin, Etoposide, and Cisplatin Versus Carboplatin AUC7 in Stage I Seminomatous Testicular Cancer

The primary objective of this randomized Phase III study is to evaluate the efficacy of one course of adjuvant **Bleomycin**, **Etoposide**, and **Cisplatin** (BEP) compared to one course of adjuvant **Carboplatin** AUC7 in reducing the relapse rate in patients with clinical stage I seminomatous **testicular cancer**. This investigation is clinically relevant as it aims to determine the most effective chemotherapy regimen for minimizing the risk of cancer recurrence in this patient population, thereby potentially improving long-term outcomes and quality of life for individuals affected by this condition.

The clinical trial focuses on **testicular cancer**, specifically targeting a male population aged between 18 and 59 years. The study does not include female participants and does not involve a vulnerable population. The sponsor has not provided the total number of participants. The trial population was selected based on specific criteria, including a histological diagnosis of unilateral seminoma testicular cancer, clinical stage I, and tumor size over 4 cm or stromal invasion of the rete testis. Participants are required to have a normal value of AFP before orchiectomy, with a stable, slightly elevated AFP considered permissible. Eligible participants must have an ECOG performance status of 0, 1, or 2 and demonstrate adequate organ function, as defined by specific laboratory values. Lifestyle considerations include the requirement for all fertile patients to use safe contraception for six months following adjuvant treatment. Written informed consent is mandatory for participation in the study.

The clinical trial is a **randomized**, **controlled**, Phase III study designed to compare the efficacy of one course of adjuvant **Bleomycin**, **Etoposide**, and **Cisplatin** (BEP) with one course of **Carboplatin** AUC7 in patients with clinical stage I seminomatous **testicular cancer**. The primary objective is to evaluate the relapse rate, while secondary endpoints include short-term and long-term toxicity, health-related quality of life, overall survival, and health economy analysis. The trial is expected to run from April 2015 to December 2032, with an estimated recruitment period starting in 2015.

Participants will be involved in the study for a maximum treatment period of up to five days, depending on the assigned treatment arm. The study includes several key visits: an initial screening visit to confirm eligibility based on criteria such as histological diagnosis, tumor size, and organ function; treatment visits for the administration of chemotherapy via **intravenous administration**; and follow-up visits to monitor for relapse and assess secondary endpoints. The end-of-study visit will conclude the participant's involvement, where final assessments will be conducted.

Inclusion criteria require participants to have a histological diagnosis of unilateral seminoma testicular cancer, be within the age range of 18 to 60 years, and have an ECOG performance status of 0, 1, or 2. Adequate organ function and written informed consent are also necessary. Participants may be terminated early from the study if they experience unacceptable toxicity, withdraw consent, or if the investigator deems it in the participant's best interest. The trial is not classified as a low-intervention study, and it is conducted under rigorous scientific and ethical standards to ensure the validity and reliability of the results.

The clinical trial involves the administration of **Carboplatin**, a chemotherapy agent with the active substance name carboplatin. It is provided in the pharmaceutical form coded as PHF00230MIG and is administered via **intravenous administration**. The maximum daily dose is 1500 mg, with a total dose not exceeding 1500 mg over a treatment period of 1 day. This medication is used as a comparator treatment in the study.

**Etoposide** is another chemotherapy agent used in the trial, with the active substance name etoposide. It is provided in the pharmaceutical form coded as PHF675 and is also administered intravenously. The dosing regimen allows for a maximum daily dose of 100 mg/m², with a total dose not exceeding 500 mg/m² over a treatment period of 5 days. Etoposide is part of the experimental treatment group in the study.

**Cisplatin** is included in the trial as part of the experimental treatment group. The active substance name is cisplatin, and it is provided in the pharmaceutical form coded as PHF00015MIG. It is administered via intravenous administration, with a maximum daily dose of 20 mg/m² and a total dose not exceeding 100 mg/m² over a treatment period of 5 days.

**Bleomycin** is also part of the experimental treatment group, with the active substance name bleomycin. It is provided in the pharmaceutical form coded as PHF00231MIG and administered intravenously. The dosing schedule allows for a maximum daily dose of 30,000 units, with a total dose not exceeding 90,000 units over a treatment period of 3 days. Bleomycin is a mixture, unlike the other chemical substances in the trial.

Efficacy in this clinical trial will be assessed primarily through the evaluation of the **relapse rate** in patients with clinical stage I seminomatous testicular cancer. The trial aims to compare the efficacy of one course of adjuvant Bleomycin, Etoposide, and Cisplatin (BEP) against one course of Carboplatin AUC7. The primary endpoint is the relapse rate, which will be systematically measured and analyzed to determine the comparative effectiveness of the treatment regimens.

Secondary endpoints include assessments of short-term and long-term toxicity, health-related quality of life, overall survival, and health economy analysis. These parameters will be collected and analyzed at specified intervals throughout the trial to provide a comprehensive evaluation of the treatment's impact on patients. The trial is designed as a randomized Phase III study, ensuring rigorous assessment of the efficacy and safety of the treatment options under investigation.