NCT01081262 · OUTCOME
Progression-free 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
- Is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.
What was measured
Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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) | 36.1 | Not reported | 2.0 | NA | Upper limit not yet reached |
| Arm II (Oxaliplatin and Capecitabine) | 7.4 | Not reported | 4.5 | NA | Upper limit not yet reached |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | 15.4 | Not reported | 4.9 | NA | Upper limit not yet reached |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | 23.3 | Not reported | 9.1 | NA | Upper limit not yet reached |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit not yet reached
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- NA
- value
- 36.1
- comment
- Upper limit not yet reached
- group Id
- OG001
- lower Limit
- 4.5
- upper Limit
- NA
- value
- 7.4
- comment
- Upper limit not yet reached
- group Id
- OG002
- lower Limit
- 4.9
- upper Limit
- NA
- value
- 15.4
- comment
- Upper limit not yet reached
- group Id
- OG003
- lower Limit
- 9.1
- upper Limit
- NA
- value
- 23.3
- 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
- Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- 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
- Is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle