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NCT05874063 | RECRUITING | Germ Cell Tumor

Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
Sponsor:

Gustave Roussy, Campus Cancer, Grand Paris

Brief Summary:

The goal of this clinical trial is to assess the efficacy of thromboprophylaxis in preventing venous thromboembolic events (VTE) in good and intermediate prognosis patients with metastatic germ cell cancer (GCT) undergoing first-line cisplatin-based chemotherapy with risk factors for developing a thromboembolic event . The high-risk patients will be randomized between two treatments arm (receiving a thromboprophylaxis in the experimental arm, or no thromboprophylaxis in the control arm). The low-risk patients will be observed without any thromboprophylaxis. Patients will participate in the study for 14-17 weeks depending on the planned number of cycles of chemotherapy. Researchers will compare an experimental arm with thromboprophylaxis and a control arm without thromboprophylaxis to detect an absolute decrease of 12% of the proportion of patients having experienced a VTE, from 21% (high risk patients, control arm) to 9% (high risk patients, experimental arm).

Condition or disease

Germ Cell Tumor

Intervention/treatment

Thromboprophylaxis

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 387 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
Actual Study Start Date : 2023-10-17
Estimated Primary Completion Date : 2028-02
Estimated Study Completion Date : 2028-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Diagnosis of good or intermediate prognosis of Germ Cell Tumor (according to the International Germ Cell Cancer Collaborative Group)
  • * Older than 18 years
  • * Suitable for first-line cisplatin-based chemotherapy
  • * No prior systemic cytotoxic therapy
  • * Signed informed consent
  • * Additional criteria for patients who will be randomized (Venous Thromboembolic Event (VTE) high-risk patients): Lactate dehydrogenase higher than 1 Upper Normal Level and/or Body Surface Area higher than 1.9 and/or longer than 5 cm long axis retroperitoneal lymph nodes
  • * Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
  • * Patients must be affiliated to a social security system or beneficiary of the same
Exclusion Criteria
  • * Brain metastasis
  • * History of VTE
  • * Concomitant use of anticoagulants or antiaggregants
  • * Renal impairment defined as creatinine clearance less than 50 ml/min using Cockcroft-Gault formula
  • * Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients
  • * Any major surgery (i.e. open surgery lasting more than 45 minutes from opening to closure) within 4 weeks or planned during the study treatment period
  • * Severe uncontrolled high blood pressure (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg)
  • * Low baseline platelet count (\< 100 X 10\^9 /L) or history of heparin-induced thrombocytopenia
  • * Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
  • * Extensive metastatic disease at high risk of bleeding, e.g. prevalent choriocarcinoma
  • * Participation in another clinical study with an investigational product during the last 4 weeks, and while on study treatment without the approval from sponsor
  • * Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

Location Details

NCT05874063

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

France,

Ico Paul Papin

Angers, France, 49100

RECRUITING

France,

CH of the Basque Coast

Bayonne, France, 64100

RECRUITING

France,

Chu the clemont-ferrand

Clermont-Ferrand, France, 63000

RECRUITING

France,

Oscar Lambret Center

Lille, France, 59000

RECRUITING

France,

chu's Limoges

Limoges, France, 87000

RECRUITING

France,

Center Léon Bérard

Lyon, France, 69000

RECRUITING

France,

Center Antoine Lacassagne

Nice, France, 06189

RECRUITING

France,

Saint Louis Hospital

Paris, France, 75010

RECRUITING

France,

Poitiers of chu

Poitiers, France, 86000

RECRUITING

France,

La Croix du Sud clinic

Quint-Fonsegrives, France, 31130

RECRUITING

France,

Center Eugène Marquis

Rennes, France, 35000

RECRUITING

France,

Western Cancer Institute

Saint-Herblain, France, 44805

RECRUITING

France,

Hia Bégin

Saint-Mandé, France, 94160

RECRUITING

France,

Chu de stane

Saint-Etienne, France, 42270

RECRUITING

France,

ICANS

Strasbourg, France, 67200

RECRUITING

France,

CHU Bretonneau

Tours, France, 37044

RECRUITING

France,

Lorraine Cancer Institute

Vandoeuvre les nancy, France, 54500

RECRUITING

France,

Gustave Roussy

Villejuif, France, 94800