TriangleNCT02122185 · OUTCOME
Time to Biochemical (CA-125) Progression, Radiological Progression, or Death.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 6 years
What was measured
CA125 progression determined using GCIG criteria. Radiological progression assessed using RECIST criteria as described above for PFS. For example, progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Groups in this outcome
Metformin Plus Chemotherapy
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity. metformin hydrochloride: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
Placebo Plus Chemotherapy
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity. placebo: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
| Group | Source count |
|---|---|
| Metformin Plus Chemotherapy | 54 |
| Placebo Plus Chemotherapy | 54 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Metformin Plus Chemotherapy | 14.4 | Not reported | 11.0 | 17.1 | Not reported |
| Placebo Plus Chemotherapy | 13.7 | Not reported | 11.5 | 17.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.66
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.61
- estimate Comment
- Adjusted for initial treatment (primary debulking surgery or neoadjuvant therapy followed by surgery) and planned chemotherapy regimen.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.89
- p Value Comment
- Two-sided
- param Type
- Cox Proportional Hazard
- param Value
- 1.03
- statistical Comment
- Stratified by initial treatment (primary debulking surgery or neoadjuvant therapy followed by surgery) and planned chemotherapy regimen.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.66
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.61
- estimate Comment
- Adjusted for initial treatment (primary debulking surgery or neoadjuvant therapy followed by surgery) and planned chemotherapy regimen.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.89
- p Value Comment
- Two-sided
- param Type
- Cox Proportional Hazard
- param Value
- 1.03
- statistical Comment
- Stratified by initial treatment (primary debulking surgery or neoadjuvant therapy followed by surgery) and planned chemotherapy regimen.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.0
- upper Limit
- 17.1
- value
- 14.4
- group Id
- OG001
- lower Limit
- 11.5
- upper Limit
- 17.9
- value
- 13.7
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 54
- units
- Participants
- description
- CA125 progression determined using GCIG criteria. Radiological progression assessed using RECIST criteria as described above for PFS. For example, progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity. metformin hydrochloride: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
- id
- OG000
- title
- Metformin Plus Chemotherapy
- description
- Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity. placebo: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
- id
- OG001
- title
- Placebo Plus Chemotherapy
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Up to 6 years
- title
- Time to Biochemical (CA-125) Progression, Radiological Progression, or Death.
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice