Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00075582 · OUTCOME

Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy

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
stimated percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From enrollment up to 5 years

What was measured

The local failure rate will be estimated using cumulative incidence curves.

Analysis population: Patients who received reduced doses of radiation therapy.

Groups in this outcome

Regimen I (Chemotherapy, Radiotherapy)

Stage I/II group IIA 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)

Group III patients with orbit primary 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

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)52
Regimen II (Chemotherapy, Radiotherapy, Surgery)62

Reported measurements

Source class 1
Values in stimated percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen I (Chemotherapy, Radiotherapy)0.081Not reported0.0460.116Not reported
Regimen II (Chemotherapy, Radiotherapy, Surgery)0.115Not reported0.0350.195Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.046
        upper Limit
        0.116
        value
        0.081
      2. group Id
        OG001
        lower Limit
        0.035
        upper Limit
        0.195
        value
        0.115
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    2. group Id
      OG001
      value
      62
    units
    Participants
description
The local failure rate will be estimated using cumulative incidence curves.
dispersion Type
95% Confidence Interval
groups
  1. description
    Stage I/II group IIA 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
    Group III patients with orbit primary 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
    OG001
    title
    Regimen II (Chemotherapy, Radiotherapy, Surgery)
param Type
NUMBER
population Description
Patients who received reduced doses of radiation therapy.
reporting Status
POSTED
time Frame
From enrollment up to 5 years
title
Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy
type
SECONDARY
unit Of Measure
stimated percentage of participants

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

Preserved source evidence · Not medical advice