NCT00588770 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- FG000
- title
- Chemotherapy Arm (Arm A)
- description
- ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
- id
- FG001
- title
- Chemotherapy+Bevacizumab (Arm B)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 85
- group Id
- FG001
- num Subjects
- 68
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 29
- group Id
- FG001
- num Subjects
- 58
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 13
- group Id
- FG001
- num Subjects
- 22
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 15
- group Id
- FG001
- num Subjects
- 25
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 4
- type
- Alternative therapy
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 2
- type
- Other complicating disease
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 9
- type
- Not start protocol therapy
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 10
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 0
- type
- Physician discretion
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 2
- type
- Patient non-compliance
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 200
- group Id
- FG001
- num Subjects
- 203
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 188
- group Id
- FG001
- num Subjects
- 183
- type
- Eligible
- achievements
- group Id
- FG000
- num Subjects
- 200
- group Id
- FG001
- num Subjects
- 194
- type
- Start Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 41
- group Id
- FG001
- num Subjects
- 3
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 159
- group Id
- FG001
- num Subjects
- 200
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- E1305 was activated on August 8, 2008 and closed on February 11,2015, with final accrual of 403 patients.
Complete source fields
- groups
- description
- ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- FG000
- title
- Chemotherapy Arm (Arm A)
- description
- ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
- id
- FG001
- title
- Chemotherapy+Bevacizumab (Arm B)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 85
- group Id
- FG001
- num Subjects
- 68
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 29
- group Id
- FG001
- num Subjects
- 58
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 13
- group Id
- FG001
- num Subjects
- 22
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 15
- group Id
- FG001
- num Subjects
- 25
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 4
- type
- Alternative therapy
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 2
- type
- Other complicating disease
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 9
- type
- Not start protocol therapy
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 10
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 0
- type
- Physician discretion
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 2
- type
- Patient non-compliance
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 200
- group Id
- FG001
- num Subjects
- 203
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 188
- group Id
- FG001
- num Subjects
- 183
- type
- Eligible
- achievements
- group Id
- FG000
- num Subjects
- 200
- group Id
- FG001
- num Subjects
- 194
- type
- Start Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 41
- group Id
- FG001
- num Subjects
- 3
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 159
- group Id
- FG001
- num Subjects
- 200
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- E1305 was activated on August 8, 2008 and closed on February 11,2015, with final accrual of 403 patients.
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Preserved source evidence · Not medical advice
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