TriangleNCT00565851 · OUTCOME
To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer
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
- The time frame is 82.5 months (median duration of follow-up).
What was measured
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
Analysis population: All patients who were enrolled between December 10, 2007 and August 26, 2011 and received paclitaxel and carboplatin (with or without bevacizumab) (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
Groups in this outcome
Paclitaxel and Carboplatin Chemotherapy
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
| Group | Source count |
|---|---|
| Paclitaxel and Carboplatin Chemotherapy | 337 |
| Paclitaxel and Carboplatin Chemotherapy With Bevacizumab | 337 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Paclitaxel and Carboplatin Chemotherapy | 37.3 | Not reported | 32.6 | 39.7 | Not reported |
| Paclitaxel and Carboplatin Chemotherapy With Bevacizumab | 42.2 | Not reported | 37.7 | 46.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.6
- upper Limit
- 39.7
- value
- 37.3
- group Id
- OG001
- lower Limit
- 37.7
- upper Limit
- 46.2
- value
- 42.2
- denoms
- counts
- group Id
- OG000
- value
- 337
- group Id
- OG001
- value
- 337
- units
- Participants
- description
- The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
- id
- OG000
- title
- Paclitaxel and Carboplatin Chemotherapy
- description
- All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
- id
- OG001
- title
- Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
- param Type
- MEDIAN
- population Description
- All patients who were enrolled between December 10, 2007 and August 26, 2011 and received paclitaxel and carboplatin (with or without bevacizumab) (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
- reporting Status
- POSTED
- time Frame
- The time frame is 82.5 months (median duration of follow-up).
- title
- To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice