TriangleNCT00022633 · OUTCOME
Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- 66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)
What was measured
Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.
Analysis population: A total of 55 patients aged 70 years and older were registered to this protocol from July, 2001 to December, 2006.
Groups in this outcome
Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
| Group | Source count |
|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | 55 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 55
- denoms
- counts
- group Id
- OG000
- value
- 55
- units
- Participants
- description
- Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.
- groups
- description
- Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
- id
- OG000
- title
- Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
- param Type
- NUMBER
- population Description
- A total of 55 patients aged 70 years and older were registered to this protocol from July, 2001 to December, 2006.
- reporting Status
- POSTED
- time Frame
- 66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)
- title
- Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice