NCT01081262 · OUTCOME
Overall Survival
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
- Up to five years
What was measured
Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact.
Analysis population: All randomized patients
Groups in this outcome
Arm I (Carboplatin and Paclitaxel)
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
Arm II (Oxaliplatin and Capecitabine)
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III. Bevacizumab: Given IV Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
| Group | Source count |
|---|---|
| Arm I (Carboplatin and Paclitaxel) | 13 |
| Arm II (Oxaliplatin and Capecitabine) | 13 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | 13 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carboplatin and Paclitaxel) | 37.6 | Not reported | 8.8 | NA | Upper limit not yet reached |
| Arm II (Oxaliplatin and Capecitabine) | 27.8 | Not reported | 9.3 | NA | Upper limit not yet reached |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | 27.7 | Not reported | 4.9 | 53.6 | Not reported |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | 55.7 | Not reported | 9.9 | NA | Upper limit not yet reached. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit not yet reached
- group Id
- OG000
- lower Limit
- 8.8
- upper Limit
- NA
- value
- 37.6
- comment
- Upper limit not yet reached
- group Id
- OG001
- lower Limit
- 9.3
- upper Limit
- NA
- value
- 27.8
- group Id
- OG002
- lower Limit
- 4.9
- upper Limit
- 53.6
- value
- 27.7
- comment
- Upper limit not yet reached.
- group Id
- OG003
- lower Limit
- 9.9
- upper Limit
- NA
- value
- 55.7
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 11
- units
- Participants
- description
- Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
- id
- OG000
- title
- Arm I (Carboplatin and Paclitaxel)
- description
- Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
- id
- OG001
- title
- Arm II (Oxaliplatin and Capecitabine)
- description
- Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
- id
- OG002
- title
- Arm III (Carboplatin, Paclitaxel, Bevacizumab)
- description
- Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III. Bevacizumab: Given IV Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
- id
- OG003
- title
- Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
- param Type
- MEDIAN
- population Description
- All randomized patients
- reporting Status
- POSTED
- time Frame
- Up to five years
- title
- Overall Survival
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice
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