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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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
RKH Klinken Ludwigsburg-Bietigheim gGmbH Ludwigsburg Germany
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Rotkreuzklinikum Muenchen gGmbH Munich Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Ulpkuxoaul Mzcltbq Cfnslb Hcdoleinuwydyafxp Hamburg Germany
Vwwkncer Nbgeeonk fyhj Gnzihnrpja Gcrp Berlin Germany
Kwykdblx Epebktwarxkwhowimuethtdn Hfkxrxdskdddaeswi Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.09.2020

Trial locations

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.

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 ID:
2023-509663-24-00
Protocol code:
SAKK 01/18
NCT ID:
NCT03937843
Trial Phase:
Therapeutic exploratory (Phase II)

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