TriangleNCT00075582 · OUTCOME
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Estimated percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From enrollment up to 5 years
What was measured
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Analysis population: All eligible patients among this subset of regimen 2 patients were included in this outcome measure to regimen 2 patients (there were 16 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.
Groups in this outcome
Regimen II (Chemotherapy, Radiotherapy, Surgery)
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
| Group | Source count |
|---|---|
| Regimen II (Chemotherapy, Radiotherapy, Surgery) | 69 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen II (Chemotherapy, Radiotherapy, Surgery) | 67 | Not reported | 52 | 79 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 52
- upper Limit
- 79
- value
- 67
- denoms
- counts
- group Id
- OG000
- value
- 69
- units
- Participants
- description
- Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- title
- Regimen II (Chemotherapy, Radiotherapy, Surgery)
- param Type
- NUMBER
- population Description
- All eligible patients among this subset of regimen 2 patients were included in this outcome measure to regimen 2 patients (there were 16 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.
- reporting Status
- POSTED
- time Frame
- From enrollment up to 5 years
- title
- Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry
- type
- PRIMARY
- unit Of Measure
- Estimated percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice