NCT00075582 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
- id
- FG000
- title
- Regimen I (Chemotherapy, Radiotherapy)
- description
- Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
- id
- FG001
- title
- Regimen II (Chemotherapy, Radiotherapy, Surgery)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 8
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 8
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 2
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 36
- group Id
- FG001
- num Subjects
- 16
- type
- Ineligible for study
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 305
- group Id
- FG001
- num Subjects
- 85
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 255
- group Id
- FG001
- num Subjects
- 50
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 50
- group Id
- FG001
- num Subjects
- 35
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
- id
- FG000
- title
- Regimen I (Chemotherapy, Radiotherapy)
- description
- Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
- id
- FG001
- title
- Regimen II (Chemotherapy, Radiotherapy, Surgery)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 8
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 8
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 2
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 36
- group Id
- FG001
- num Subjects
- 16
- type
- Ineligible for study
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 305
- group Id
- FG001
- num Subjects
- 85
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 255
- group Id
- FG001
- num Subjects
- 50
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 50
- group Id
- FG001
- num Subjects
- 35
- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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