NCT01042522 · 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
- pi Sponsor Employee
- false
- restriction Type
- LTE60
- restrictive Agreement
- true
- limitations And Caveats
- description
- An interim analysis was planned occur after 20 PFS events were observed in either arm (roughly 50% information time). The futility threshold for paclitaxel and carboplatin relative to BEP was HR\>1.10. Median followup time was 48 months. The study closed at the interim analysis for futility, and difficulty with accrual. At the time of closures, 63 of a planned 128 patients had enrolled at the time of accrual suspension.
- point Of Contact
- purdyc@nrgoncology.org
- organization
- NRG Oncology
- phone
- (716) 845-1300
- phone Ext
- 2296
- title
- Christopher Purdy on behalf of Austin Miller PhD
Complete source fields
- certain Agreement
- pi Sponsor Employee
- false
- restriction Type
- LTE60
- restrictive Agreement
- true
- limitations And Caveats
- description
- An interim analysis was planned occur after 20 PFS events were observed in either arm (roughly 50% information time). The futility threshold for paclitaxel and carboplatin relative to BEP was HR\>1.10. Median followup time was 48 months. The study closed at the interim analysis for futility, and difficulty with accrual. At the time of closures, 63 of a planned 128 patients had enrolled at the time of accrual suspension.
- point Of Contact
- purdyc@nrgoncology.org
- organization
- NRG Oncology
- phone
- (716) 845-1300
- phone Ext
- 2296
- title
- Christopher Purdy on behalf of Austin Miller PhD
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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