A Phase 3 interventional study of Thromboprophylaxis in Germ Cell Tumor, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Recruiting at 26 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 3, Interventional, and Supportive care
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).
291 studies on the registry are indexed under Neoplasms, Germ Cell and Embryonal; 51 are open to participants now.
This study's planned enrollment of 387 is above the median of 37 across 211 interventional studies indexed under Neoplasms, Germ Cell and Embryonal.
Browse Neoplasms, Germ Cell and Embryonal studies →Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Thromboprophylaxis in addition of the standard chemotherapy
Drug: Thromboprophylaxis
No thromboprophylaxis in addition of the standard chemotherapy
No thromboprophylaxis in addition of the standard chemotherapy
Thromboprophylaxis in addition of the standard chemotherapy
Proportion of patients undergoing a thromboembolic event
(composite end point: symptomatic or asymptomatic (incidental finding) venous thrombosis or pulmonary embolism or unexplained death)
Time frame: from randomization up to 6 weeks after D1 of the last cycle of chemotherapy or up to the residual masses surgery, whichever occurs first.
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Neoplasms, Germ Cell and Embryonal→
Gustave Roussy, Cancer Campus, Grand Paris