NCT00183820 · OUTCOME
Tumor Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From start of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 weeks, through study completion, up to 9 years
What was measured
Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.
Analysis population: 1 patient was inevaluable.
Groups in this outcome
Paclitaxel, Gemcitabine, and Oxaliplatin
paclitaxel, gemcitabine, and oxaliplatin: 1. Paclitaxel 170 mg/m2 IV d 1 14 days 2. Gemcitabine 800 mg/m2 IV d 1 14 days 3. Oxaliplatin 100 mg/m2 IV d 1 14 days
| Group | Source count |
|---|---|
| Paclitaxel, Gemcitabine, and Oxaliplatin | 29 |
Reported measurements
Source class 1
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Paclitaxel, Gemcitabine, and Oxaliplatin | 2 | Not reported | Not reported | Not reported | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Paclitaxel, Gemcitabine, and Oxaliplatin | 7 | Not reported | Not reported | Not reported | Not reported |
Stable Disease (SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Paclitaxel, Gemcitabine, and Oxaliplatin | 15 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Paclitaxel, Gemcitabine, and Oxaliplatin | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Complete Response (CR)
- measurements
- group Id
- OG000
- value
- 7
- title
- Partial Response (PR)
- measurements
- group Id
- OG000
- value
- 15
- title
- Stable Disease (SD)
- measurements
- group Id
- OG000
- value
- 5
- title
- Progressive Disease (PD)
- denoms
- counts
- group Id
- OG000
- value
- 29
- units
- Participants
- description
- Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.
- groups
- description
- paclitaxel, gemcitabine, and oxaliplatin: 1. Paclitaxel 170 mg/m2 IV d 1 14 days 2. Gemcitabine 800 mg/m2 IV d 1 14 days 3. Oxaliplatin 100 mg/m2 IV d 1 14 days
- id
- OG000
- title
- Paclitaxel, Gemcitabine, and Oxaliplatin
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 1 patient was inevaluable.
- reporting Status
- POSTED
- time Frame
- From start of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 weeks, through study completion, up to 9 years
- title
- Tumor Response
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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