TriangleNCT00103259 · OUTCOME
Response Rate on Step 1
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
- 90% Confidence Interval
- Time frame
- Tumor response was assessed every 2 cycles until progression or intolerable toxicity with maximum of 3 years
What was measured
Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
Analysis population: 61 eligible and treated patients were included in the analysis
Groups in this outcome
Arm I (Bortezomib+Irinotecan)
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II (Bortezomib)
Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
| Group | Source count |
|---|---|
| Arm I (Bortezomib+Irinotecan) | 23 |
| Arm II (Bortezomib) | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Bortezomib+Irinotecan) | 13.1 | Not reported | 3.6 | 30.3 | Not reported |
| Arm II (Bortezomib) | 2.6 | Not reported | 0.4 | 22.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.6
- upper Limit
- 30.3
- value
- 13.1
- group Id
- OG001
- lower Limit
- 0.4
- upper Limit
- 22.1
- value
- 2.6
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 38
- units
- Participants
- description
- Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm I (Bortezomib+Irinotecan)
- description
- Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
- id
- OG001
- title
- Arm II (Bortezomib)
- param Type
- NUMBER
- population Description
- 61 eligible and treated patients were included in the analysis
- reporting Status
- POSTED
- time Frame
- Tumor response was assessed every 2 cycles until progression or intolerable toxicity with maximum of 3 years
- title
- Response Rate on Step 1
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice