Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
ConditionGerm Cell Tumor
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Thromboprophylaxis
DrugThromboprophylaxis in addition of the standard chemotherapy
Treatment groups
387 Participants
are divided into 3 treatment groupsGroup A: Experimental for high-risk patientsExperimental treatment 1 intervention
Group B: Control for high-risk patientsNo intervention 0 interventions
Group C: Low-risk patientsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.Sponsors and contacts
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Source ClinicalTrials.gov