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NCT00075582 · OUTCOME

Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry

Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma · Source last updated 2021-11-19

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: Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.

Groups in this outcome

Regimen I (Chemotherapy, Radiotherapy)

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

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Regimen I (Chemotherapy, Radiotherapy)269
Regimen II (Chemotherapy, Radiotherapy, Surgery)69

Reported measurements

Source class 1
Values in Estimated percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen I (Chemotherapy, Radiotherapy)87Not reported8291Not reported
Regimen II (Chemotherapy, Radiotherapy, Surgery)67Not reported5279Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        82
        upper Limit
        91
        value
        87
      2. group Id
        OG001
        lower Limit
        52
        upper Limit
        79
        value
        67
denoms
  1. counts
    1. group Id
      OG000
      value
      269
    2. group Id
      OG001
      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
  1. 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
    OG000
    title
    Regimen I (Chemotherapy, Radiotherapy)
  2. 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
    OG001
    title
    Regimen II (Chemotherapy, Radiotherapy, Surgery)
param Type
NUMBER
population Description
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
reporting Status
POSTED
time Frame
From enrollment up to 5 years
title
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 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