Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Thromboprophylaxis

Treatment groups

387 Participants
are divided into 3 treatment groups