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RecruitingTesticular germ cell tumour
Study on Preventing Blood Clots in Patients with Advanced Germ Cell Tumors Using Cisplatin and a Drug Combination
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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 patients with advanced germ cell tumors, which are a type of cancer that can occur in the reproductive cells. The study aims to evaluate the effectiveness of a treatment called thromboprophylaxis in preventing blood clots, known as venous thromboembolic events (VTE), in patients who have a good or intermediate prognosis. These patients are undergoing their first round of chemotherapy that includes a drug called cisplatin. The study is particularly interested in patients who have certain risk factors for developing blood clots, such as high levels of a substance called LDH in their blood, a body surface area greater than 1.9, or large lymph nodes in the abdomen.
The trial involves the use of several medications, including Cisplatin, INNOHEP (which contains tinzaparin sodium), Fragmin (which contains dalteparin sodium), and LOVENOX (which contains enoxaparin sodium). These medications are administered through injections and are designed to help prevent blood clots. Some patients in the study may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.
The study will last for a period of up to 13 weeks, during which patients will receive their assigned treatment and be monitored for any occurrence of blood clots or other side effects. The goal is to determine how well the thromboprophylaxis treatment works in preventing blood clots in patients with advanced germ cell tumors who are at risk. The results will help doctors understand the benefits and risks of using these medications in similar patients in the future.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
10 criteria
- Diagnosis of good or intermediate prognosis Germ Cell Tumor (as defined by the IGCCCG Group).
- Must be 18 years or older.
- Suitable for first-line cisplatin-based chemotherapy.
- No prior treatment with systemic cytotoxic therapy (a type of cancer treatment that uses drugs to kill cancer cells).
- Must have signed informed consent (a document that explains the study and confirms your agreement to participate).
- For patients at high risk of blood clots (VTE), one or more of the following must apply:
- LDH (a type of enzyme) levels are higher than normal.
- BSA (Body Surface Area) is greater than 1.9.
- Retroperitoneal lymph nodes (glands in the abdomen) are larger than 5 cm.
- Must understand, sign, and date the written informed consent form before any study-specific procedures are done. Must be able and willing to attend study visits and follow procedures as required by the study.
- Must be affiliated with a social security system or be a beneficiary of one.
Who cannot join the trial?
2 criteria
- Patients who are female cannot participate in the study. This study is only for male patients.
- Patients who are part of a vulnerable population cannot participate. This means groups of people who might need special protection or care.
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Verified sites
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Verified Verified CHU Gabriel-Montpied
Clermont Ferrand, FranceResponsive Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France
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Investigated drugs
Cisplatin is a type of chemotherapy medication used to treat various types of cancer, including germ cell tumors. It works by stopping the growth of cancer cells, which are then destroyed by the body. In this trial, cisplatin is used as part of the first-line treatment for patients with advanced germ cell tumors. The goal is to help reduce the size of the tumors and control the spread of cancer.
What is already known about the treatment
Cisplatin – Cisplatin is administered intravenously, meaning it is given through a vein, typically in a hospital or clinic setting. It is a well-established chemotherapy drug used in the treatment of various cancers, including advanced germ cell tumors. The main therapeutic indication for cisplatin in this context is to treat metastatic germ cell cancer, particularly in patients with a good or intermediate prognosis. At the molecular level, cisplatin works by binding to DNA in cancer cells, causing damage that prevents the cells from dividing and growing, ultimately leading to cell death. It is classified as a platinum-based antineoplastic agent, which is a type of chemotherapy drug that contains platinum and is used to kill cancer cells.
Investigated diseases
Metastatic Germ Cell Cancer – Metastatic germ cell cancer is a type of cancer that originates in the reproductive cells and spreads to other parts of the body. It often begins in the testicles or ovaries but can also start in other areas like the chest or abdomen. As the disease progresses, cancer cells travel through the bloodstream or lymphatic system, forming new tumors in distant organs. The progression can lead to symptoms such as lumps, pain, or swelling in the affected areas. Over time, the disease may cause additional symptoms depending on the organs involved, such as respiratory issues if the lungs are affected. The spread and growth of cancer cells can disrupt normal organ function, leading to further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502426-41-00Protocol code2022/3510 GIG-TEstimated enrolment387 patientsSponsorInstitut Gustave Roussy
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