TriangleNCT00069121 · OUTCOME
Overall Survival [Time to Event]
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
What was measured
Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
Analysis population: Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
Groups in this outcome
5-FU/LV
Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
XELOX
Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
| Group | Source count |
|---|---|
| 5-FU/LV | 942 |
| XELOX | 944 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 5-FU/LV | NA | Not reported | 0 | 95 | The median time to death was not reached in this adjuvant trial. |
| XELOX | NA | Not reported | 0 | 93 | The median time to death was not reached in this adjuvant trial. |
Source statistical analyses
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.99
- estimate Comment
- The hazard ratio was calculated as XELOX versus 5-FU/LV arms.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Descriptive analysis only.
- non Inferiority Type
- OTHER
- p Value
- 0.0367
- param Type
- Hazard Ratio (HR)
- param Value
- 0.83
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.99
- estimate Comment
- The hazard ratio was calculated as XELOX versus 5-FU/LV arms.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Descriptive analysis only.
- non Inferiority Type
- OTHER
- p Value
- 0.0367
- param Type
- Hazard Ratio (HR)
- param Value
- 0.83
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The median time to death was not reached in this adjuvant trial.
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 95
- value
- NA
- comment
- The median time to death was not reached in this adjuvant trial.
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 93
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 942
- group Id
- OG001
- value
- 944
- units
- Participants
- description
- Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
- dispersion Type
- Full Range
- groups
- description
- Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
- id
- OG000
- title
- 5-FU/LV
- description
- Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
- id
- OG001
- title
- XELOX
- param Type
- MEDIAN
- population Description
- Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
- title
- Overall Survival [Time to Event]
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice