Study Comparing Two Chemotherapy Regimens (Carboplatin vs. Cisplatin) for Malignant Germ Cell Tumors Outside the Brain

Germ cell tumors are malignant diseases that develop from the abnormal precursors of sex cells (eggs or sperm). They are particularly common in the brain, chest, ovaries, testicles, and coccyx. Germ cell tumors are a common form of cancer among adolescents and young adults. Treatment is tailored to different risk groups. Patients are assigned to these groups based on specific criteria such as the tumor’s location and extent, the presence of metastases (spread to other organs), the type of tissue affected, and the patient’s age. In the early stages of the disease, the tumor is surgically removed. Depending on the risk group, chemotherapy may be recommended following surgery. In advanced stages, chemotherapy is often administered first, and any remaining tumor tissue can then be removed. Standard chemotherapy is based, among other things, on cisplatin, which has proven to be very effective against these types of tumors; however, it can cause serious side effects such as kidney damage or hearing loss. Carboplatin has a similar effect on cancer cells but is better tolerated. To date, carboplatin has only been used in specific cases, such as when cisplatin cannot be administered (e.g., in cases of pre-existing kidney insufficiency).

The goal of this Phase 3 study is to investigate the efficacy and safety of carboplatin compared to cisplatin and to determine whether carboplatin is just as effective as cisplatin against germ cell tumors in certain patients, but with fewer debilitating side effects. As part of the study, patients are divided into three risk groups. This classification is based on tumor location, stage, age, and resection status—that is, whether the tumor was completely removed during surgery or not. Treatment is then determined based on the risk assessment. Before chemotherapy begins—depending on the extent of the tumor—the tumor is surgically removed as much as possible, or, if that is not possible, a tumor sample is first taken (tumor biopsy). In the low-risk group, additional chemotherapy may be omitted, and patients undergo regular follow-up examinations (the so-called “watch-and-wait” strategy). In the intermediate- and high-risk groups, patients are randomly assigned to two groups—one group receives chemotherapy with carboplatin, and the other with cisplatin. The study is open-label, meaning that both the medical staff and the patient know which medications are being administered. The treatments and follow-up examinations as part of the study will continue for up to 9 years, during which the effectiveness of the therapy and the occurrence of side effects from the various medications will be evaluated. The primary endpoint of the study is event-free survival (EFS), defined as the time after treatment without, for example, disease recurrence, disease progression, or disease-related death.

Women up to age 29 with an ovarian germ cell tumor and men up to age 17 with a germ cell tumor outside the brain (extracranial) are eligible to participate in this study. The tumor must not have been previously treated with chemotherapy.