TriangleNCT00803062 · OUTCOME
Tumor Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.
What was measured
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR.
Analysis population: All randomized patients.
Groups in this outcome
Arm I (Paclitaxel and Cisplatin)
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
Arm II (Paclitaxel, Cisplatin, Bevacizumab)
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
Arm III (Topotecan Hydrochloride and Paclitaxel)
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
| Group | Source count |
|---|---|
| Arm I (Paclitaxel and Cisplatin) | 114 |
| Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 115 |
| Arm III (Topotecan Hydrochloride and Paclitaxel) | 111 |
| Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) | 112 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Paclitaxel and Cisplatin) | 44.74 | Not reported | 35.42 | 54.34 | Not reported |
| Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 49.57 | Not reported | 40.11 | 59.04 | Not reported |
| Arm III (Topotecan Hydrochloride and Paclitaxel) | 27.03 | Not reported | 19.03 | 36.28 | Not reported |
| Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) | 47.32 | Not reported | 37.81 | 56.98 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.42
- upper Limit
- 54.34
- value
- 44.74
- group Id
- OG001
- lower Limit
- 40.11
- upper Limit
- 59.04
- value
- 49.57
- group Id
- OG002
- lower Limit
- 19.03
- upper Limit
- 36.28
- value
- 27.03
- group Id
- OG003
- lower Limit
- 37.81
- upper Limit
- 56.98
- value
- 47.32
- denoms
- counts
- group Id
- OG000
- value
- 114
- group Id
- OG001
- value
- 115
- group Id
- OG002
- value
- 111
- group Id
- OG003
- value
- 112
- units
- Participants
- description
- Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
- id
- OG000
- title
- Arm I (Paclitaxel and Cisplatin)
- description
- Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
- id
- OG001
- title
- Arm II (Paclitaxel, Cisplatin, Bevacizumab)
- description
- Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
- id
- OG002
- title
- Arm III (Topotecan Hydrochloride and Paclitaxel)
- description
- Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
- id
- OG003
- title
- Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
- param Type
- NUMBER
- population Description
- All randomized patients.
- reporting Status
- POSTED
- time Frame
- Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.
- title
- Tumor Response
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice