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Study on Reducing Treatment for Stage IIa/IIb Seminoma Using Etoposide, Cisplatin, and Carboplatin in Patients with Tumors Smaller than 3 cm

Verified siteRegistered drugNo placebo

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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 a type of cancer called seminoma, specifically in its early stages, known as stage IIa/IIb, where the tumor is less than 3 cm in size. The study aims to evaluate a treatment approach that involves reducing the intensity of therapy. Initially, patients will receive one cycle of a combination of two chemotherapy drugs, etoposide and cisplatin. After three weeks, if a special scan called FDG-PET shows no signs of cancer, patients will either receive one cycle of another chemotherapy drug, carboplatin, or a focused dose of radiation therapy on the lymph nodes.

The purpose of this study is to assess how effective this reduced treatment approach is in delaying the return of cancer. The study will monitor patients over time to see how long they remain free of cancer. Additionally, the study will explore the relationship between a specific biomarker, miRNA-M371, and the response to treatment. This biomarker is a small molecule found in the blood that may help predict how well the treatment is working.

Participants in the study will undergo regular check-ups and tests to monitor their health and the status of their cancer. The study will also evaluate the overall safety of the treatment and its impact on the quality of life of the participants. The trial is expected to continue for several years to gather comprehensive data on the effectiveness and safety of the treatment approach.

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
Initial treatment phase
The initial treatment involves one cycle of a combination of two medications: etoposide and cisplatin. These medications are administered through a vein, a method known as intravenous use.
The purpose of this phase is to evaluate the response of the seminoma to the treatment.
Step 2
Evaluation phase
Three weeks after the initial treatment, a specialized scan called FDG-PET is performed. This scan helps to determine the activity of the seminoma.
A negative result on this scan indicates that the seminoma is not active.
Step 3
Follow-up treatment phase
If the FDG-PET scan is negative, the next step involves either one cycle of carboplatin or a focused dose of radiation therapy on the lymph nodes.
Carboplatin is also administered intravenously, with a specific dosage calculated as AUC 7.
Step 4
Monitoring phase
Throughout the trial, regular monitoring is conducted to assess the response to treatment and to check for any side effects.
The primary goal is to evaluate the time until the first relapse of the seminoma.
Step 5
Long-term follow-up
The progression-free rate is assessed at 36 months to determine the effectiveness of the treatment.
Additional evaluations include the correlation between serum levels of a specific biomarker, miRNA-M371, and the response to treatment.

Who can join the trial?

13 criteria

Must be at least 18 years old on the day of signing the consent form.
Must be willing and able to attend scheduled visits, follow treatment plans, and undergo laboratory tests and other study procedures.
Must agree to use effective birth control methods or abstain from heterosexual activity during the study and for 12 months after the last dose of chemotherapy, or be surgically sterile. Patients should consider sperm preservation before starting treatment due to the risk of infertility.
Must have health insurance.
Must sign and date the informed consent form.
Must have a primary testicular seminomatous germ cell tumor.
Must have a stage IIa/IIb seminoma that is less than 3 cm in size, confirmed by a tissue sample after surgery to remove the testicle.
Must have confirmation of disease progression, shown by a positive FDG-PET scan or an increase in lymph node size on two CT scans.
Must have a good prognosis according to specific criteria and a level of LDH (a type of enzyme) that is less than 2.5 times the upper limit of normal.
Must have normal levels of AFP (a protein) before and after surgery to remove the testicle.
Must not have had previous treatment with radiotherapy or chemotherapy.
Must have an ECOG performance status of 2 or less, which means being able to carry out all self-care but unable to carry out any work activities.
Must have adequate bone marrow, liver, and kidney function, with specific blood test results meeting certain criteria.

Who cannot join the trial?

4 criteria

Patients with a seminoma larger than 3 cm cannot participate. A seminoma is a type of testicular cancer.
Patients who do not have Stage IIa or IIb seminoma are excluded. These stages refer to the size and spread of the cancer.
Patients who are not able to undergo the specific treatments being tested in the study, such as certain chemotherapy drugs or radiotherapy, cannot join.
Patients who are part of a vulnerable population, meaning they might need special protection or care, are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Besancon University Hospital Center
Verified
Besançon, France
Centre De Lutte Contre Le Cancer Eugene Marquis
Verified
Rennes, France
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

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Investigated drugs

Etoposide
is a medication used in this trial as part of the initial treatment cycle. It works by interfering with the growth of cancer cells, which are eventually destroyed. It is often used in combination with other medications to treat certain types of cancer, including seminomas.
Cisplatin
is another medication used in the initial treatment cycle. It is a chemotherapy drug that helps to kill cancer cells by damaging their DNA, preventing them from dividing and growing. Cisplatin is commonly used in combination with other drugs to treat various types of cancer.
Carboplatin
is used in this trial as a follow-up treatment if the initial response to therapy is positive. It is a chemotherapy drug similar to cisplatin, and it works by damaging the DNA of cancer cells, which stops them from growing and dividing. Carboplatin is often used when a less aggressive treatment is needed.
Radiotherapy
is a treatment option in this trial that involves using high-energy rays to target and kill cancer cells. It is used as a boost to treat lymph nodes if the initial response to therapy is positive. Radiotherapy is a common treatment for various types of cancer and can be used alone or in combination with other treatments.

What is already known about the treatment

Etoposide
Etoposide is administered intravenously and is used in combination with other medications for treating certain types of cancer, including seminoma. It is currently well-established in medical practice and literature as a chemotherapy agent. The main therapeutic indication for etoposide in this context is the treatment of stage IIa/IIb seminoma. At the molecular level, etoposide works by inhibiting an enzyme called topoisomerase II, which is essential for DNA replication and cell division, leading to cancer cell death. It is classified as a topoisomerase inhibitor.
Cisplatin
Cisplatin is administered intravenously and is a widely used chemotherapy drug in the treatment of various cancers, including seminoma. It is well-documented in medical literature and is a standard treatment option. The primary therapeutic indication for cisplatin in this trial is to treat stage IIa/IIb seminoma. Cisplatin works by forming cross-links in DNA, which prevents cancer cells from dividing and leads to cell death. It is classified as a platinum-based chemotherapy agent.
Carboplatin
Carboplatin is administered intravenously and is used as a chemotherapy treatment for various cancers, including seminoma. It is recognized in medical literature as an effective treatment option. In this trial, carboplatin is indicated for stage IIa/IIb seminoma. Its mechanism of action involves binding to DNA and interfering with the cell's repair mechanism, leading to cell death. Carboplatin is classified as a platinum-based chemotherapy drug.

Investigated diseases

Stage IIa/IIb Seminoma – This is a type of testicular cancer that is classified as stage IIa or IIb, indicating that the cancer has spread to nearby lymph nodes but remains less than 3 cm in size. Seminomas are germ cell tumors that typically grow slowly and are sensitive to radiation therapy. In stage IIa, the cancer has spread to one or more lymph nodes, none larger than 2 cm. In stage IIb, the cancer has spread to lymph nodes, with at least one node measuring between 2 and 5 cm. The progression of the disease involves the potential for further spread to additional lymph nodes or other parts of the body if not managed. Regular monitoring and imaging tests are often used to track the progression of the disease.