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Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

Study acronym: GIG-T
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 18 to 26
    • Eligibility criteria shortened, about 3 words
    v5
  2. Study sites: 15 to 18v4
  3. Study sites: 14 to 15v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 14
    • Primary and study completion dates: Nov 2027 to Feb 2028
    • Start date changed from estimate of Jul 2023 to Oct 17, 2023
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05874063
Lead Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Conditions
(from sponsor)		 Germ Cell Tumor
Related terms Neoplasms, Germ Cell and Embryonal
Enrollment 387 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov