NCT00069095 · OUTCOME
Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer · Source last updated 2016-10-06
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Week 1 to Week 54
What was measured
For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.
Analysis population: The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Groups in this outcome
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
1. Folfox-4: 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 (given on day 1).
2. Folfox-4+P: 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 placebo control for bevacizumab (both given on day 1 every 2 weeks).
3. 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).
XELOX/XELOX+P/XELOX+BV
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
1. Xelox: 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 (given on day 1).
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).
3. 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 937 |
|---|
| XELOX/XELOX+P/XELOX+BV | 967 |
|---|
Reported measurements
Week 1-6
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 67 | Not reported | Not reported | Not reported | Not reported |
|---|
| XELOX/XELOX+P/XELOX+BV | 93 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 7-12
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 190 | Not reported | Not reported | Not reported | Not reported |
|---|
| XELOX/XELOX+P/XELOX+BV | 191 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 13-18
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 155 | Not reported | Not reported | Not reported | Not reported |
|---|
| XELOX/XELOX+P/XELOX+BV | 110 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 19-24
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| XELOX/XELOX+P/XELOX+BV | 38 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 25-30
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| XELOX/XELOX+P/XELOX+BV | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 31-36
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| XELOX/XELOX+P/XELOX+BV | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 37-42
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| XELOX/XELOX+P/XELOX+BV | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 49-54
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| XELOX/XELOX+P/XELOX+BV | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 93
- title
- Week 1-6
- categories
- measurements
- group Id
- OG000
- value
- 190
- group Id
- OG001
- value
- 191
- title
- Week 7-12
- categories
- measurements
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 110
- title
- Week 13-18
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 38
- title
- Week 19-24
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 13
- title
- Week 25-30
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 3
- title
- Week 31-36
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- title
- Week 37-42
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Week 49-54
- denoms
- counts
- group Id
- OG000
- value
- 937
- group Id
- OG001
- value
- 967
- units
- Participants
- description
- For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.
- groups
- description
- Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
1. Folfox-4: 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 (given on day 1).
2. Folfox-4+P: 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 placebo control for bevacizumab (both given on day 1 every 2 weeks).
3. 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).
- id
- OG000
- title
- FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
- description
- Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -
1. Xelox: 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 (given on day 1).
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).
3. 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
- XELOX/XELOX+P/XELOX+BV
- param Type
- NUMBER
- population Description
- The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
- reporting Status
- POSTED
- time Frame
- Week 1 to Week 54
- title
- Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
- type
- SECONDARY
- unit Of Measure
- Participants
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