TriangleNCT00112918 · OUTCOME
Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis
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
- From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).
What was measured
Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive.
Analysis population: ITT patients with Stage III disease.
Groups in this outcome
FOLFOX4
Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only.
FOLFOX4 + Bv
Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).
XELOX+Bv
Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which 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 first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).
| Group | Source count |
|---|---|
| FOLFOX4 | 955 |
| FOLFOX4 + Bv | 960 |
| XELOX+Bv | 952 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FOLFOX4 | NA | Not reported | NA | NA | Median time to event and 95% confidence intervals could not be estimated due to the low number of events. |
| FOLFOX4 + Bv | NA | Not reported | NA | NA | Median time to event and 95% confidence intervals could not be estimated due to the low number of events. |
| XELOX+Bv | NA | Not reported | NA | NA | Median time to event and 95% confidence intervals could not be estimated due to the low number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median time to event and 95% confidence intervals could not be estimated due to the low number of events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median time to event and 95% confidence intervals could not be estimated due to the low number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median time to event and 95% confidence intervals could not be estimated due to the low number of events.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 955
- group Id
- OG001
- value
- 960
- group Id
- OG002
- value
- 952
- units
- Participants
- description
- Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only.
- id
- OG000
- title
- FOLFOX4
- description
- Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).
- id
- OG001
- title
- FOLFOX4 + Bv
- description
- Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which 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 first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).
- id
- OG002
- title
- XELOX+Bv
- param Type
- MEDIAN
- population Description
- ITT patients with Stage III disease.
- reporting Status
- POSTED
- time Frame
- From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).
- title
- Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice