NCT00052910 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 280
- group Id
- BG001
- value
- 266
- group Id
- BG002
- value
- 546
- units
- Participants
- groups
- description
- Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
- id
- BG000
- title
- Arm I (5-FU/LV)
- description
- Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
- id
- BG001
- title
- Arm II (ECF)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 23
- upper Limit
- 81
- value
- 59
- group Id
- BG001
- lower Limit
- 29
- upper Limit
- 83
- value
- 58
- group Id
- BG002
- lower Limit
- 23
- upper Limit
- 83
- value
- 58.6
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 87
- group Id
- BG001
- value
- 88
- group Id
- BG002
- value
- 175
- title
- Female
- measurements
- group Id
- BG000
- value
- 193
- group Id
- BG001
- value
- 178
- group Id
- BG002
- value
- 371
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 21
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 38
- title
- Canada
- categories
- measurements
- group Id
- BG000
- value
- 259
- group Id
- BG001
- value
- 249
- group Id
- BG002
- value
- 508
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 280
- group Id
- BG001
- value
- 266
- group Id
- BG002
- value
- 546
- units
- Participants
- groups
- description
- Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
- id
- BG000
- title
- Arm I (5-FU/LV)
- description
- Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
- id
- BG001
- title
- Arm II (ECF)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 23
- upper Limit
- 81
- value
- 59
- group Id
- BG001
- lower Limit
- 29
- upper Limit
- 83
- value
- 58
- group Id
- BG002
- lower Limit
- 23
- upper Limit
- 83
- value
- 58.6
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 87
- group Id
- BG001
- value
- 88
- group Id
- BG002
- value
- 175
- title
- Female
- measurements
- group Id
- BG000
- value
- 193
- group Id
- BG001
- value
- 178
- group Id
- BG002
- value
- 371
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 21
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 38
- title
- Canada
- categories
- measurements
- group Id
- BG000
- value
- 259
- group Id
- BG001
- value
- 249
- group Id
- BG002
- value
- 508
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle