TriangleNCT00069095 · OUTCOME
BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of responders
- Interval / dispersion
- Not reported
- Time frame
- From baseline until disease progression/recurrence, approximately 2 years 6 months
What was measured
According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.
Analysis population: The ITT population included all randomized participants who provided written informed consent.
Groups in this outcome
FOLFOX-4+P/XELOX+P
Participants from the 2x2 factorial part of the study including the following groups - 1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
FOLFOX-4+BV/XELOX+BV
Participants from the 2x2 factorial part of the study including the following groups - 1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks). 2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
| Group | Source count |
|---|---|
| FOLFOX-4+P/XELOX+P | 701 |
| FOLFOX-4+BV/XELOX+BV | 699 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FOLFOX-4+P/XELOX+P | 37.5 | Not reported | Not reported | Not reported | Not reported |
| FOLFOX-4+BV/XELOX+BV | 37.5 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.78
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 97.5
- ci Upper Limit
- 1.28
- group Description
- Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX 4+P/XELOX+P) \</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \> 1.0. The test used a two-sided significance level of 2.5%
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.9887
- param Type
- Odds Ratio (OR)
- param Value
- 1.00
- statistical Method
- Chi-squared
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.78
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 97.5
- ci Upper Limit
- 1.28
- group Description
- Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX 4+P/XELOX+P) \</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \> 1.0. The test used a two-sided significance level of 2.5%
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.9887
- param Type
- Odds Ratio (OR)
- param Value
- 1.00
- statistical Method
- Chi-squared
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 37.5
- group Id
- OG001
- value
- 37.5
- denoms
- counts
- group Id
- OG000
- value
- 701
- group Id
- OG001
- value
- 699
- units
- Participants
- description
- According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.
- groups
- description
- Participants from the 2x2 factorial part of the study including the following groups - 1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
- id
- OG000
- title
- FOLFOX-4+P/XELOX+P
- description
- Participants from the 2x2 factorial part of the study including the following groups - 1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks). 2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
- id
- OG001
- title
- FOLFOX-4+BV/XELOX+BV
- param Type
- NUMBER
- population Description
- The ITT population included all randomized participants who provided written informed consent.
- reporting Status
- POSTED
- time Frame
- From baseline until disease progression/recurrence, approximately 2 years 6 months
- title
- BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
- type
- SECONDARY
- unit Of Measure
- Percentage of responders
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Preserved source evidence · Not medical advice