NCT01231906 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9.
- id
- FG000
- title
- Arm A (Combination Chemotherapy)
- description
- INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19.
- id
- FG001
- title
- Arm B (Combination Chemotherapy, Topotecan Hydrochloride)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 75
- group Id
- FG001
- num Subjects
- 68
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 34
- group Id
- FG001
- num Subjects
- 24
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 4
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 10
- group Id
- FG001
- num Subjects
- 3
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 2
- type
- No treatment
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 319
- group Id
- FG001
- num Subjects
- 323
- comment
- Eligible and began receiving protocol therapy
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 308
- group Id
- FG001
- num Subjects
- 318
- type
- Received Therapy
- achievements
- group Id
- FG000
- num Subjects
- 198
- group Id
- FG001
- num Subjects
- 222
- comment
- Completion of planned therapy with no event observed: disease progression, second malignant neoplasm (SMN), death regardless of cause
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 121
- group Id
- FG001
- num Subjects
- 101
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9.
- id
- FG000
- title
- Arm A (Combination Chemotherapy)
- description
- INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19.
- id
- FG001
- title
- Arm B (Combination Chemotherapy, Topotecan Hydrochloride)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 75
- group Id
- FG001
- num Subjects
- 68
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 34
- group Id
- FG001
- num Subjects
- 24
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 4
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 10
- group Id
- FG001
- num Subjects
- 3
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 2
- type
- No treatment
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 319
- group Id
- FG001
- num Subjects
- 323
- comment
- Eligible and began receiving protocol therapy
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 308
- group Id
- FG001
- num Subjects
- 318
- type
- Received Therapy
- achievements
- group Id
- FG000
- num Subjects
- 198
- group Id
- FG001
- num Subjects
- 222
- comment
- Completion of planned therapy with no event observed: disease progression, second malignant neoplasm (SMN), death regardless of cause
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 121
- group Id
- FG001
- num Subjects
- 101
- type
- NOT COMPLETED
- title
- Overall Study
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