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Study on Reduced Intensity Radio-Chemotherapy for Stage IIA/B Seminoma Using Etoposide, Cisplatin, and Carboplatin for Patients with Stage IIA/B Seminoma

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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 Stage IIA/B seminoma, which is a form of testicular cancer. The study is exploring a treatment approach that combines reduced intensity radio-chemotherapy. The medications being used in this study include Etomedac (active substance: etoposide), Cisplatin NeoCorp (active substance: cisplatin), and Carboplat onkovis (active substance: carboplatin). These medications are administered as a solution for infusion, which means they are given through a vein.

The purpose of the study is to investigate the effectiveness of this treatment regimen for patients with Stage IIA/B seminoma. Participants in the study will receive the treatment over a period of time, and their health will be monitored to see how well the cancer responds to the treatment. The study will also look at how long patients remain free from cancer progression, which means the cancer does not get worse, over a period of three years.

Throughout the study, various health assessments will be conducted, including imaging tests like CT or MRI scans, to check the status of the cancer. The study aims to gather information on the response rate to the treatment, the time it takes for the cancer to progress, and overall survival rates. This information will help in understanding the potential benefits of the treatment for patients with this type of cancer.

The research process

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

  1. Step 1

    Initial registration

    Upon joining the study, registration is completed. This involves confirming eligibility based on specific criteria such as age, health status, and previous medical history.

    A diagnostic scan, such as a CT or MRI, is performed to confirm the stage of the seminoma.

  2. Step 2

    Treatment initiation

    The treatment begins with the administration of medications through a solution for infusion. The medications used include etoposide, cisplatin, and carboplatin.

    These medications are given as a concentrate for solution for infusion, which means they are administered directly into the bloodstream through an IV.

  3. Step 3

    Treatment schedule

    The treatment regimen is adapted to the stage of the seminoma. The specific dosage and frequency of the medications are determined by the healthcare provider based on individual patient needs.

    The duration of the treatment is aligned with the study's objectives to assess the efficacy of the regimen.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to the treatment. This includes follow-up scans and health assessments.

    Progression-free survival is evaluated at 3 years, along with other secondary endpoints such as response rate and overall survival.

  5. Step 5

    Completion of trial

    The trial is estimated to conclude by March 31, 2045. Upon completion, the results will be analyzed to determine the effectiveness of the treatment regimen.

    Participants are advised to continue regular health check-ups and follow any additional guidance provided by their healthcare provider.

Who can join the trial?

11 criteria

  • You must provide written informed consent before joining the study. This means you agree to participate after understanding all the details.
  • Your kidneys need to be working well, with a creatinine clearance of at least 60 ml/min. This is a measure of how well your kidneys filter waste.
  • You must agree to use highly effective contraception and not donate sperm or father a child during the study and for 12 months after. You should also consider sperm conservation.
  • You need to have a confirmed diagnosis of classical seminoma, a type of testicular cancer, treated with surgery called inguinal or partial orchidectomy.
  • You should have stage IIA or IIB seminoma, either newly diagnosed or recurring after previous treatments like surveillance, carboplatin, or radiotherapy. The cancer should not have spread beyond certain areas.
  • If you have stage IIA with uncertain lymph node enlargement, it must be confirmed with another CT or MRI scan to ensure accuracy.
  • You must have had a CT, MRI, or FDG-PET-CT scan of your chest, abdomen, and pelvis within 28 days before joining, showing stage IIA/B disease. A contrast medium should be used during the scan.
  • You must be at least 18 years old.
  • Your WHO performance status should be between 0 and 2, indicating your ability to carry out daily activities.
  • You need to complete the baseline PRO questionnaires, which are surveys about your health and well-being.
  • Your bone marrow should be functioning well, with a neutrophil count of at least 1.0 x 10^9/L and a platelet count of at least 100 x 10^9/L. These are measures of your blood health.

Who cannot join the trial?

4 criteria

  • Only males can participate, so females are excluded.
  • Individuals who do not have **Stage IIA/B seminoma** cannot participate. **Stage IIA/B seminoma** is a specific type of testicular cancer.
  • Participants must be within a certain age range, so those outside this range are excluded.
  • Vulnerable populations, such as those who may not be able to give informed consent, are excluded.
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Investigated drugs

  • Carboplatin

    is a chemotherapy medication used in this trial to treat seminoma, a type of testicular cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. This helps to reduce the size of the tumor and stop the cancer from spreading.

  • Radiotherapy

    is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, radiotherapy is used alongside chemotherapy to enhance the overall effectiveness of the treatment for stage IIA/B seminoma. The goal is to destroy cancer cells while minimizing damage to surrounding healthy tissue.

What is already known about the treatment

Cisplatin – Cisplatin is administered intravenously and is commonly used in chemotherapy treatments. It is currently well-established in medical practice and literature as an effective treatment for various types of cancer, including testicular cancer such as Stage IIA/B seminoma. The main therapeutic indication for Cisplatin is its use in combination with other drugs to treat cancer by damaging the DNA of cancer cells, which prevents them from dividing and growing. At the molecular level, Cisplatin forms cross-links with DNA, disrupting the DNA structure and function, leading to cell death. It is classified as a platinum-based antineoplastic agent.

Investigated diseases

Stage IIA/B Seminoma – This is a type of testicular cancer that originates in the germ cells of the testicles. It is classified as stage IIA/B when the cancer has spread to nearby lymph nodes but not to distant parts of the body. The disease typically progresses slowly, and symptoms may include a painless lump or swelling in the testicle, discomfort, or a feeling of heaviness in the scrotum. As the cancer advances, it may cause back pain or abdominal discomfort due to lymph node involvement. The progression of seminoma is often monitored through imaging and physical examinations to assess the spread and response to treatment.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509663-24-00Protocol codeSAKK 01/18Estimated enrolment180 patientsSponsorSwiss Group for Clinical Cancer Research

sourced from the EU Clinical Trials Register and site verification

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