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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying testicular cancer, specifically a type called seminomatous testicular cancer that has not spread to other parts of the body. The study aims to compare the effectiveness of two different chemotherapy treatments in reducing the risk of cancer returning. The first treatment involves a combination of three drugs: Bleomycin, Etoposide, and Cisplatin, often referred to as BEP. The second treatment uses a single drug called Carboplatin. Both treatments are given through a vein, which is known as intravenous administration.

The purpose of the study is to determine if one course of the BEP treatment results in a lower chance of the cancer coming back compared to one course of Carboplatin. Participants in the study will receive one of these treatments and will be monitored over time to see how well the treatment works and to check for any side effects. The study will also look at the overall health and quality of life of the participants during and after the treatment.

Throughout the study, researchers will collect information on the relapse rate, which is the likelihood of the cancer returning. They will also assess any short-term and long-term side effects of the treatments, the overall survival of participants, and how the treatments impact their quality of life. Additionally, the study will include an analysis of the economic aspects related to the health care provided during the trial. The study is expected to continue until the end of 2032.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, the patient is enrolled based on specific criteria, including a diagnosis of unilateral seminoma testicular cancer at clinical stage I, with a tumor size over 4 cm or stromal invasion of the rete testis.
The patient must be between 18 and 60 years old, with adequate organ function and a specific performance status. Written informed consent is required.
Step 2
Treatment assignment
The patient is randomly assigned to one of two treatment groups. One group receives a course of adjuvant BEP (bleomycin, etoposide, and cisplatin), while the other group receives a course of carboplatin AUC7.
Both treatments are administered through intravenous administration.
Step 3
Treatment administration
For the BEP group, the patient receives bleomycin, etoposide, and cisplatin intravenously. The specific dosage and frequency are determined by the study protocol.
For the carboplatin AUC7 group, the patient receives carboplatin intravenously, with the dosage calculated based on the area under the curve (AUC) method.
Step 4
Monitoring and follow-up
The patient undergoes regular monitoring to assess the treatment's effectiveness and any side effects. This includes evaluating the relapse rate, short-term and long-term toxicity, and overall health-related quality of life.
Follow-up visits are scheduled according to the study protocol to ensure ongoing assessment of the patient's condition and response to treatment.
Step 5
Completion
The study is estimated to conclude by December 31, 2032. Upon completion, the patient's overall survival and health economy analysis are evaluated as part of the study's secondary endpoints.
The patient is advised to use safe contraception for six months following the adjuvant treatment to prevent any potential risks.

Who can join the trial?

13 criteria

Must have a confirmed diagnosis of **testicular cancer** on one side, specifically a type called **seminoma**. This involves checking the size of the tumor and whether it has invaded a part of the testis called the **rete testis**.
Must be in **clinical stage I**, which means the cancer is limited to the testis and has not spread.
The tumor must be larger than 4 cm or have invaded the **rete testis**.
Must have a normal level of a protein called **AFP** (alpha-fetoprotein) before surgery to remove the testis. A slightly higher but stable AFP level might be acceptable.
Must be between 18 and 59 years old.
Must have an **ECOG performance status** of 0, 1, or 2, which is a scale that measures how well a person can perform daily activities. 0 means fully active, 1 means some symptoms but nearly fully active, and 2 means unable to work but can take care of themselves.
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Must have normal organ function, which includes:
- **ALT** (a liver enzyme) level no more than 1.5 times the normal upper limit.
- **Bilirubin** (a substance made by the liver) level no more than 1.5 times the normal upper limit.
- **Neutrophil count** (a type of white blood cell) at least 1.5 x 10⁹/L.
- **Platelet count** (cells that help blood clot) at least 100 x 10⁹/L.
- **GFR** (a measure of kidney function) greater than 50 ml/min.
- If fertile, must use effective birth control for 6 months after treatment. Options include using a condom, sterilization, or the partner using hormonal contraceptives, sterilization, or an intrauterine device.
- Must provide written informed consent, which means agreeing to participate after understanding the study details.

Who cannot join the trial?

3 criteria

Patients who are not male cannot participate in the study.
Patients who do not have testicular cancer cannot participate in the study.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their own interests, such as children or people with certain disabilities.

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Verified sites

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Region Oestergoetland
Linkoping, Sweden
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Region Vaesterbotten
Umea, Sweden
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Universitetssykehuset Nord-Norge HF
Tromsø, Norway

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Investigated drugs

Bleomycin
is a medication used in cancer treatment. It works by interfering with the growth of cancer cells, which are eventually destroyed. In this trial, it is part of a combination therapy to treat testicular cancer.
Etoposide
is a chemotherapy drug that helps stop the growth of cancer cells by causing them to die. It is used in combination with other medications to enhance its effectiveness in treating testicular cancer.
Cisplatin
is a chemotherapy medication that kills cancer cells by damaging their DNA. It is often used in combination with other drugs to treat various types of cancer, including testicular cancer.
Carboplatin
is a chemotherapy drug similar to cisplatin, used to treat cancer by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, it is being compared to the combination of bleomycin, etoposide, and cisplatin to see which is more effective in preventing cancer relapse.

What is already known about the treatment

Bleomycin
This medication is administered through injection into a vein. It is currently used in the treatment of various cancers, including testicular cancer, and is well-documented in medical literature. Bleomycin is primarily indicated for its ability to treat certain types of cancer by interfering with the growth of cancer cells. At the molecular level, it works by causing breaks in DNA strands, which prevents cancer cells from dividing and growing. It is classified as an antineoplastic antibiotic.
Etoposide
Etoposide is given as an intravenous infusion. It is widely recognized in the medical community for its role in cancer treatment, particularly for testicular cancer. The main therapeutic use of etoposide is to inhibit the growth of cancer cells. It acts by inhibiting an enzyme called topoisomerase II, which is essential for DNA replication, thus preventing cancer cell division. Etoposide is classified as a topoisomerase inhibitor.
Cisplatin
Administered intravenously, cisplatin is a well-established chemotherapy drug used in the treatment of various cancers, including testicular cancer. Its primary therapeutic indication is to kill cancer cells by damaging their DNA and preventing them from dividing. Cisplatin works at the molecular level by forming cross-links in DNA, which disrupts DNA synthesis and function. It is classified as a platinum-based antineoplastic agent.
Carboplatin
This medication is also administered through an intravenous infusion. It is a recognized treatment option for several types of cancer, including testicular cancer, and is well-documented in medical literature. Carboplatin is used to treat cancer by interfering with the DNA of cancer cells, preventing them from growing and dividing. It works by forming cross-links in DNA, similar to cisplatin, and is classified as a platinum-based chemotherapy drug.

Investigated diseases

Testicular cancer – Testicular cancer is a disease where malignant cells form in the tissues of one or both testicles. It often begins as a painless lump or swelling in the testicle, which may be discovered during a self-exam or routine physical check-up. As the disease progresses, it may cause discomfort or pain in the testicle or scrotum, a feeling of heaviness, or a dull ache in the lower abdomen or groin. In some cases, it can lead to changes in the size or shape of the testicles. The cancer can spread to other parts of the body, such as the lymph nodes, lungs, liver, or brain, if not detected and managed early. Testicular cancer is most common in young and middle-aged men, but it can occur at any age.