This clinical trial is focused on studying Malignant Extracranial Germ Cell Tumors, which are a type of cancer that occurs outside the brain. The trial aims to compare the effectiveness of two chemotherapy drugs, Carboplatin and Cisplatin, in treating these tumors. Both drugs are used to kill cancer cells and are administered through an intravenous method, meaning they are given directly into a vein.
The purpose of the study is to determine if Carboplatin is as effective as Cisplatin in treating patients with these tumors. Participants in the study will receive either Carboplatin or Cisplatin and will be monitored over time to see how well the treatment works. The study will look at how long patients remain free from cancer events, such as tumor growth or recurrence, and will also consider overall survival rates.
Throughout the study, researchers will also assess the safety of the treatments by monitoring any side effects or adverse reactions. Additionally, the study will evaluate other factors such as the number of hospital days required during treatment and the need for blood transfusions. The trial is expected to continue until 2028, providing valuable information on the best treatment options for patients with Malignant Extracranial Germ Cell Tumors.
1joining the trial
Upon joining the trial, you will be randomly assigned to receive either Carboplatin or Cisplatin as part of your treatment for malignant germ cell tumors.
This assignment is part of a study to compare the effectiveness of these two medications.
2treatment plan
If assigned to Carboplatin, you will receive a dose of 600 mg/m² per cycle, administered through an intravenous infusion.
If assigned to Cisplatin, you will receive a dose of 100 mg/m² per cycle, also administered through an intravenous infusion.
The treatment cycles will be repeated as per the trial protocol, and your doctor will provide specific details about the frequency and duration.
3monitoring and assessments
Throughout the trial, regular monitoring will be conducted to assess your response to the treatment.
This includes checking standard tumor marker levels after each cycle and evaluating any side effects or adverse events.
Your overall health and any changes in your condition will be closely observed.
4follow-up evaluations
After completing the treatment cycles, follow-up evaluations will be conducted to determine the effectiveness of the treatment.
These evaluations will include imaging tests and possibly additional laboratory tests to check for any remaining tumor cells or changes in your condition.
5end of trial participation
Your participation in the trial will conclude after the final follow-up evaluations are completed.
The results of your treatment will contribute to the overall findings of the study, which aims to improve treatment options for patients with malignant germ cell tumors.
Who Can Join the Study?
Confirmed extracranial MGCT (Malignant Germ Cell Tumours outside the brain) up to 17 years and 11 months of age, or patients with ovarian primaries up to 29 years and 11 months of age on the date of written informed consent.
Diagnosis of a chemotherapy-naïve extracranial MGCT, meaning the patient has not received chemotherapy treatment for this condition before.
Written informed consent from patients and/or their parents according to national law before joining the trial.
Karnofsky Index of more than 70% or ECOG Status of 0-II. These are scales used to measure the patient’s ability to perform daily activities. A higher score means the patient is more capable.
Negative pregnancy test within 7 days before starting treatment for female patients who can have children. If the MGCT secretes a hormone called ß-HCG, pregnancy must be ruled out using appropriate methods.
Who Cannot Join the Study?
Patients with other types of cancer that are not Malignant Extracranial Germ Cell Tumours (MGCT).
Patients who have previously received treatment with Carboplatin or Cisplatin for MGCT.
Patients with severe kidney problems, as these drugs can affect kidney function.
Patients with severe hearing problems, as these drugs can affect hearing.
Patients who are pregnant or breastfeeding, as the drugs may harm the baby.
Patients who are unable to follow the study procedures or attend follow-up visits.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate.
Carboplatin is a medication used in this clinical trial to treat certain types of cancer, specifically malignant germ cell tumors. It works by interfering with the DNA in cancer cells, which prevents them from growing and dividing. This medication is being tested to see if it is as effective as another drug, Cisplatin, in helping patients live longer without the cancer coming back.
Cisplatin is another medication used in the trial for treating malignant germ cell tumors. Like Carboplatin, it also targets the DNA of cancer cells, stopping them from multiplying. The trial aims to compare Cisplatin with Carboplatin to determine which one is more effective in preventing the return of cancer in patients with these tumors.
Malignant Extracranial Germ Cell Tumors – These are a type of cancer that originates from germ cells, which are cells that develop into sperm or eggs. They occur outside the brain and spinal cord, often in areas like the abdomen, chest, or pelvis. The disease can grow and spread to other parts of the body, including lymph nodes and distant organs. As the tumor progresses, it may cause symptoms such as pain, swelling, or a noticeable mass. The progression can vary, with some tumors growing slowly while others may advance more rapidly. The disease is categorized into different risk groups based on factors like tumor size and spread, which can influence its progression.
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