Risk of Venous Thromboembolism in Patients Receiving First-Line Chemotherapy for Disseminated Germ Cell Tumours - a Multi-Site Retrospective Cohort Study as Part of the Global Germ-Cell Cancer Group (G3) Consortium
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,135
- Locations
- 1
- Primary Endpoint
- To validate the association between large RPLN metastases (measuring >5cm in axial dimension) and increased risk of VTE during and immediately after completion of (within 90 days) first line chemotherapy for disseminated GCT
Study Overview
Brief Summary
Recent data (Srikanthan and Tran et al. JCO 2014, in press) have demonstrated that the presence of large retroperitoneal lymph node metastases on baseline staging scans (measuring >5cm in axial dimension) are associated with significantly increased risk of venous thromboembolism in patients receiving first line chemotherapy for disseminated germ cell tumours.
This study, a G3 collaborative effort, aims to confirm these findings in a large multi-national validation cohort.
Detailed Description
Recent data (Srikanthan and Tran et al. JCO 2014, in press) have demonstrated that the presence of large retroperitoneal lymph node (RPLN) metastases on baseline staging scans (measuring >5cm in axial dimension) are associated with significantly increased risk of venous thromboembolism (VTE) in patients receiving first line chemotherapy for disseminated germ cell tumours (GCT).
This study, a G3 collaborative effort, aims to confirm these findings in a large multi-national validation cohort.
Primary objective:
To validate the association between large RPLN metastases (measuring >5cm in axial dimension) and increased risk of VTE during and immediately after completion of (within 90 days) first line chemotherapy for disseminated GCT.
Secondary objectives:
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men with disseminated GCT (AJCC Stage IS, 2, or 3)
- •Received first line chemotherapy with curative intent for disseminated GCT
- •Clinical data available from chemotherapy initiation to at least 90 days following completion of chemotherapy (patients who died prior to 90 days will be included in this study)
- •Initiated chemotherapy between 1-January-2000 and 31-December-2014* *Data collection from consecutive patients initiating chemotherapy during a defined period within the specified timeframe is acceptable (e.g. patient data from 5-year period starting 1-January-2008 and ending 31-December-2012 is acceptable)
Exclusion Criteria
- •Prior chemotherapy for GCT (including use of adjuvant chemotherapy or curative chemotherapy for prior diagnosis of disseminated GCT).
- •History of secondary malignancy (excluding non-melanoma superficial skin cancers)
Outcomes
Primary Outcomes
To validate the association between large RPLN metastases (measuring >5cm in axial dimension) and increased risk of VTE during and immediately after completion of (within 90 days) first line chemotherapy for disseminated GCT
Time Frame: March 2016
Secondary Outcomes
- To assess the discriminatory accuracy for VTE of both large RPLN metastases and high-risk Khorana score (defined as > 3)(March 2016)
- To determine the incidence of VTE in patients with disseminated GCT receiving first line chemotherapy at baseline, during chemotherapy and immediately following chemotherapy(March 2016)
- To determine the incidence of VTE during and immediately after chemotherapy in patients receiving prophylactic anticoagulation during first line chemotherapy for disseminated GCT(March 2016)
- To determine the incidence of major bleeding in patients who received prophylactic anticoagulation versus those who did not(March 2016)
- To determine overall survival at 12 months, 3 years and 5 years for patients who developed VTE compared to those who did not.(March 2016)
Investigators
Dr Ben Tran
Medical Oncologist/Clinical Researcher
Walter and Eliza Hall Institute of Medical Research