NCT01167712 · 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
- The timeframe is from enrollment onto the study up to 3 years following enrollment.
What was measured
First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. 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: Whole sample
Groups in this outcome
Arm I (Adjuvant Chemotherapy Suboptimally Debulked)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV
Arm II (Neoadjuvant Chemotherapy)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
| Group | Source count |
|---|---|
| Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 346 |
| Arm II (Neoadjuvant Chemotherapy) | 346 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Adjuvant Chemotherapy Suboptimally Debulked) | 14.7 | Not reported | 13.5 | 15.8 | Not reported |
| Arm II (Neoadjuvant Chemotherapy) | 14.0 | Not reported | 12.7 | 15.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- .74
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.06
- group Description
- Estimated hazard of first progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- .89
Complete source fields
- analyses
- ci Lower Limit
- .74
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.06
- group Description
- Estimated hazard of first progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- .89
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.5
- upper Limit
- 15.8
- value
- 14.7
- group Id
- OG001
- lower Limit
- 12.7
- upper Limit
- 15.2
- value
- 14.0
- denoms
- counts
- group Id
- OG000
- value
- 346
- group Id
- OG001
- value
- 346
- units
- Participants
- description
- First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. 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 paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV
- id
- OG000
- title
- Arm I (Adjuvant Chemotherapy Suboptimally Debulked)
- description
- Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
- id
- OG001
- title
- Arm II (Neoadjuvant Chemotherapy)
- param Type
- MEDIAN
- population Description
- Whole sample
- reporting Status
- POSTED
- time Frame
- The timeframe is from enrollment onto the study up to 3 years following enrollment.
- title
- Progression-Free Survival
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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