Ongoing Clinical Trials for Testicular Germ Cell Cancer
There are currently 2 ongoing clinical trials studying new treatments for testicular germ cell cancer. These trials are testing different chemotherapy combinations to improve outcomes for patients with newly diagnosed or relapsed disease, and are being conducted across multiple European countries.
Clinical trial locations
- Austria
- Belgium
- Denmark
- France
- Germany
- Ireland
- Italy
- Netherlands
- Spain
Study Comparing Carboplatin and Cisplatin for Patients with Extracranial Malignant Germ Cell Tumors
This trial is comparing two widely used chemotherapy drugs, Carboplatin and Cisplatin, to determine which is more effective for treating malignant germ cell tumors that occur outside the brain. Both medications work by interfering with the DNA in cancer cells, preventing them from growing and dividing.
Main inclusion criteria: The trial is open to patients up to 17 years and 11 months old with confirmed extracranial malignant germ cell tumors who have not previously received chemotherapy for this condition. For patients with ovarian tumors, the age limit extends to 29 years and 11 months. Participants must have a good ability to perform daily activities, measured by a Karnofsky Index of more than 70% or ECOG Status of 0-II. Female patients who can have children must have a negative pregnancy test within 7 days before starting treatment.
Main exclusion criteria: Patients cannot participate if they have other types of cancer, have previously received treatment with Carboplatin or Cisplatin, or have severe kidney or hearing problems. Pregnant or breastfeeding women are not eligible, nor are patients who cannot follow study procedures or have medical conditions that would make participation unsafe.
Trial focus and goals: The study aims to determine if Carboplatin is as effective as Cisplatin in treating these tumors. Researchers will monitor how long patients remain free from cancer events such as tumor growth or recurrence, and will assess overall survival rates. The trial will also evaluate safety by monitoring side effects and will look at practical factors like hospital days required and the need for blood transfusions. The study is expected to continue until 2028.
Investigational drugs: Carboplatin is administered at a dose of 600 mg/m² per cycle through an intravenous infusion. Cisplatin is given at a dose of 100 mg/m² per cycle, also through intravenous infusion. Both are platinum-based chemotherapy agents that target cancer cell DNA.
Study Comparing Chemotherapy with Paclitaxel, Ifosfamide, and Cisplatin versus High-Dose Chemotherapy with Paclitaxel and Drug Combination for Relapsed Germ Cell Tumors
This trial is comparing two different chemotherapy approaches for patients whose germ cell tumors have returned or are not responding to initial treatment. The first approach uses a combination called TIP (Paclitaxel, Ifosfamide, and Cisplatin), while the second uses a high-dose approach called TI-CE (Paclitaxel and Ifosfamide followed by high doses of Carboplatin and Etoposide).
Main inclusion criteria: Patients must be male and at least 14 years old with a confirmed diagnosis of germ cell tumor. They must have progressive or recurrent disease after receiving one type of cisplatin-based chemotherapy (between 3 to 6 cycles). Participants must test negative for HIV, HTLV, Hepatitis B, and Hepatitis C. They must have good general health status measured by an ECOG Performance Status of 0 to 2, and have adequate blood counts, kidney function, and liver function. Patients must agree to use effective birth control during the study and for about 6 months afterwards.
Main exclusion criteria: Patients cannot participate if they do not have progressive or recurrent disease, are not male, or are part of a vulnerable population that might need special protection.
Trial focus and goals: The study aims to compare overall survival between the two treatment approaches. Researchers will monitor patients closely throughout treatment to assess their response and manage any side effects. The trial will also measure progression-free survival (the time patients live without the disease getting worse) and overall response rates to determine which treatment is more effective.
Investigational drugs: The trial tests multiple chemotherapy drugs. Paclitaxel stops cancer cell growth by inhibiting cell division. Ifosfamide damages cancer cell DNA to prevent multiplication. Cisplatin also damages cancer cell DNA, leading to cell death. Carboplatin, similar to cisplatin, interferes with DNA to stop cancer cell growth. Etoposide prevents cancer cells from dividing by inhibiting an enzyme needed for DNA replication. All medications are administered intravenously.
Summary
Both ongoing trials are investigating optimal chemotherapy approaches for germ cell tumors, though they target different patient populations. The first trial focuses on newly diagnosed patients and compares two platinum-based drugs to find the most effective option with manageable side effects. The second trial addresses the more challenging situation of relapsed or treatment-resistant disease, comparing conventional-dose chemotherapy against a more intensive high-dose approach.
Geographically, these trials have strong representation across Europe, with Germany and the Netherlands participating in both studies. The second trial has particularly broad coverage across eight European countries, reflecting the need for international collaboration in studying treatments for relapsed disease. All trials use platinum-based chemotherapy agents, which remain the foundation of treatment for germ cell tumors, though they are testing different combinations and dosing strategies to improve patient outcomes.