TriangleNCT00069095 · OUTCOME
PFS (On-treatment Approach): 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
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline until disease progression or death, approximately 2 years 6 months
What was measured
PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing 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 | 241.0 | Not reported | 227 | 254 | Not reported |
| FOLFOX-4+BV/XELOX+BV | 316.0 | Not reported | 294 | 338 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 97.5
- ci Upper Limit
- 0.75
- group Description
- Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.63
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 97.5
- ci Upper Limit
- 0.75
- group Description
- Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.63
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 227
- upper Limit
- 254
- value
- 241.0
- group Id
- OG001
- lower Limit
- 294
- upper Limit
- 338
- value
- 316.0
- denoms
- counts
- group Id
- OG000
- value
- 701
- group Id
- OG001
- value
- 699
- units
- Participants
- description
- PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- The ITT population included all randomized participants who provided written informed consent.
- reporting Status
- POSTED
- time Frame
- Baseline until disease progression or death, approximately 2 years 6 months
- title
- PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice