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 study about?

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.

1 joining the study

Upon joining the study, the patient will be required to sign a consent form. This form confirms understanding of the study and agreement to participate.

The patient must meet specific criteria, such as being 18 years or older and having a diagnosis of good or intermediate prognosis germ cell tumor.

2 initial assessment

An initial assessment will be conducted to evaluate the patient’s health status and eligibility for the study. This includes checking for risk factors like elevated LDH levels or large retroperitoneal lymph nodes.

3 treatment phase

The patient will begin first-line chemotherapy treatment with cisplatin. This medication is administered as an injection.

In addition to chemotherapy, the patient will receive thromboprophylaxis treatment to prevent blood clots. This involves the use of medications such as tinzaparin sodium, dalteparin sodium, or enoxaparin sodium, which are given as subcutaneous injections.

4 monitoring and follow-up

Throughout the treatment, the patient will be monitored for any thromboembolic events, which are blood clots that can occur in veins or arteries.

Regular follow-up visits will be scheduled to assess the patient’s response to treatment and to manage any side effects.

5 end of treatment

The treatment phase will continue until the completion of chemotherapy cycles or until any necessary surgery for residual masses.

The patient will be observed for up to six weeks after the last chemotherapy cycle to monitor for any late-occurring thromboembolic events.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Comite Entreprise Paul Papin	Angers	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Hopital Tenon	Paris	France
Centre Hospitalier De La Cote Basque	Bayonne	France
Hospital Foch	Suresnes	France
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble	Grenoble	France
Institut Godinot	Reims	France
Unite De Recherche Clinique HIA Begin	Saint-Mande	France
Centre Antoine Lacassagne	Nice	France
Capio La Croix Du Sud	Quint-Fonsegrives	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
CHU Gabriel-Montpied	Clermont Ferrand	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Coztjq Hdylvcxtvqg Eo Uffobcdafpfvb Dc Lfouafr	Limoges	France
Asxbeqsdfx Pkhnzelj Hvktxcii Dn Pwqlj	Paris	France
Cgqemu Htseythsdig Rgouikcc Upxpymkvibrdv Dd Tgtvo	Tours	France
Czbltb Lidk Bxaevm	Lyon	France
Icpgyxpk do Ccxyzytvhcvs Hlqcrbcbxky Uslfffxhmmmgc dg Shjdx Eeotzvt (qbvdtrx	Saint Priest En Jarez	France
Ingyirjq Ptkrkrkfaxlkpvg Caqvwh Cooedl	Marseille	France
Cjhiqr Opbrn Lticdcl	Lille	France
Hjxwokth Urljwmagujvkhb Saqcophpjr &bdqikk Hiyynli dh Htglqvjsafz	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.02.2023

Trial locations

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.

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 ID:

2022-502426-41-00

Protocol code:

2022/3510 GIG-T

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preventing Blood Clots in Patients with Advanced Germ Cell Tumors Using Cisplatin and a Drug Combination

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