TriangleNCT00103259 · OUTCOME
Progression-free Survival on Step 1
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
- Every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry
What was measured
Progression-free survival was defined as time from registration to step 1 to disease recurrence or death from any cause, whichever occurred first. Disease progression was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and defined as at least a 20% increase 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) | 1.6 | Not reported | 1.2 | 7.3 | Not reported |
| Arm II (Bortezomib) | 1.5 | Not reported | 1.4 | 2.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- 7.3
- value
- 1.6
- group Id
- OG001
- lower Limit
- 1.4
- upper Limit
- 2.7
- value
- 1.5
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 38
- units
- Participants
- description
- Progression-free survival was defined as time from registration to step 1 to disease recurrence or death from any cause, whichever occurred first. Disease progression was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions.
- dispersion Type
- 95% 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
- MEDIAN
- population Description
- 61 eligible and treated patients were included in the analysis
- reporting Status
- POSTED
- time Frame
- Every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry
- title
- Progression-free Survival on Step 1
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice