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NCT00354835 · OUTCOME

Local Failure

Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma · Source last updated 2023-01-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
2 years

What was measured

Compare 2-year local failure rate to the historical rate of 0.13 with IRSI-V. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.13.

Analysis population: 17 ineligible participants were excluded.

Groups in this outcome

Vincristine, Dactinomycin, Cyclophosphamide (VAC)

Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.

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

Analysis denominator · Participants

GroupSource count
Vincristine, Dactinomycin, Cyclophosphamide (VAC)222

Reported measurements

Source class 1
Values in Proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Vincristine, Dactinomycin, Cyclophosphamide (VAC)0.1757Not reported0.12560.2257Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1256
        upper Limit
        0.2257
        value
        0.1757
denoms
  1. counts
    1. group Id
      OG000
      value
      222
    units
    Participants
description
Compare 2-year local failure rate to the historical rate of 0.13 with IRSI-V. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.13.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
    id
    OG000
    title
    Vincristine, Dactinomycin, Cyclophosphamide (VAC)
param Type
NUMBER
population Description
17 ineligible participants were excluded.
reporting Status
POSTED
time Frame
2 years
title
Local Failure
type
SECONDARY
unit Of Measure
Proportion of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice