TriangleNCT02186847 · OUTCOME
Percentage of Participants Alive Without Progression (Progression-free Survival)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
What was measured
Progression is defined per RECIST v1.1 as change in a known lesion(s) meeting one of the following criteria: \[1\] At least a 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be \> 5 mm. \[2\] Appearance of ≥1 new lesions. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.
Analysis population: Eligible participants
Groups in this outcome
Chemoradiation
60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
Metformin + Chemoradiation
Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
| Group | Source count |
|---|---|
| Chemoradiation | 81 |
| Metformin + Chemoradiation | 86 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemoradiation | 60.4 | Not reported | 48.5 | 70.4 | Not reported |
| Metformin + Chemoradiation | 51.3 | Not reported | 39.8 | 61.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.77
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.73
- estimate Comment
- Reference level = Chemoradiation
- group Description
- The study was powered to detect an improvement of the 1-year progression-free survival rate from 50% (no metformin) to 65% (metformin) or equivalently a hazard ratio (HR) of 0.622, at one-sided type 1 error of 0.1 and 85% power with at least 102 progression-free survival events.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7563
- param Type
- Hazard Ratio (HR)
- param Value
- 1.15
- statistical Comment
- One-sided significance level = 0.10
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.77
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.73
- estimate Comment
- Reference level = Chemoradiation
- group Description
- The study was powered to detect an improvement of the 1-year progression-free survival rate from 50% (no metformin) to 65% (metformin) or equivalently a hazard ratio (HR) of 0.622, at one-sided type 1 error of 0.1 and 85% power with at least 102 progression-free survival events.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7563
- param Type
- Hazard Ratio (HR)
- param Value
- 1.15
- statistical Comment
- One-sided significance level = 0.10
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 48.5
- upper Limit
- 70.4
- value
- 60.4
- group Id
- OG001
- lower Limit
- 39.8
- upper Limit
- 61.7
- value
- 51.3
- denoms
- counts
- group Id
- OG000
- value
- 81
- group Id
- OG001
- value
- 86
- units
- Participants
- description
- Progression is defined per RECIST v1.1 as change in a known lesion(s) meeting one of the following criteria: \[1\] At least a 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be \> 5 mm. \[2\] Appearance of ≥1 new lesions. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
- id
- OG000
- title
- Chemoradiation
- description
- Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
- id
- OG001
- title
- Metformin + Chemoradiation
- param Type
- NUMBER
- population Description
- Eligible participants
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
- title
- Percentage of Participants Alive Without Progression (Progression-free Survival)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice