TriangleNCT01730937 · MORE INFO
Limitations, agreements, and source contact
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- certain Agreement
- other Details
- PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- pi Sponsor Employee
- false
- restriction Type
- OTHER
- restrictive Agreement
- true
- limitations And Caveats
- description
- The trial closed to accrual in March 2021 at 193 of 292 planned patients due to a change in the systemic standard of care for this disease, from sorafenib to atezolizumab and bevacizumab. As the original number of OS events (238) couldn't be met, the statistical analysis plan (SAP) was revised to report the study using available patients, with data through 7/1/2022. The changes were done by a statistician independent from the trial in accordance with the NCI Policy for Major Design Amendments.
- point Of Contact
- seiferheldw@nrgoncology.org
- organization
- NRG Oncology
- phone
- 2155743208
- title
- Wendy Seiferheld
Complete source fields
- certain Agreement
- other Details
- PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- pi Sponsor Employee
- false
- restriction Type
- OTHER
- restrictive Agreement
- true
- limitations And Caveats
- description
- The trial closed to accrual in March 2021 at 193 of 292 planned patients due to a change in the systemic standard of care for this disease, from sorafenib to atezolizumab and bevacizumab. As the original number of OS events (238) couldn't be met, the statistical analysis plan (SAP) was revised to report the study using available patients, with data through 7/1/2022. The changes were done by a statistician independent from the trial in accordance with the NCI Policy for Major Design Amendments.
- point Of Contact
- seiferheldw@nrgoncology.org
- organization
- NRG Oncology
- phone
- 2155743208
- title
- Wendy Seiferheld
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice