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NCT00354835 · OUTCOME

Incidence of Bladder Dysfunction

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
Participant
Interval / dispersion
Not reported
Time frame
3-6 years after enrollment

What was measured

Number of patients with a summary score greater than 8.5

Analysis population: 470 participants were excluded due to ineligibility or absence of the dysfunctional voiding and incontinence symptoms questionnaire.

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.

VAC Alternating With Vincristine, Irinotecan (VI)

Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. 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)7
VAC Alternating With Vincristine, Irinotecan (VI)4

Reported measurements

Source class 1
Values in Participant · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vincristine, Dactinomycin, Cyclophosphamide (VAC)2Not reportedNot reportedNot reportedNot reported
VAC Alternating With Vincristine, Irinotecan (VI)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Number of patients with a summary score greater than 8.5
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)
  2. description
    Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
    id
    OG001
    title
    VAC Alternating With Vincristine, Irinotecan (VI)
param Type
NUMBER
population Description
470 participants were excluded due to ineligibility or absence of the dysfunctional voiding and incontinence symptoms questionnaire.
reporting Status
POSTED
time Frame
3-6 years after enrollment
title
Incidence of Bladder Dysfunction
type
SECONDARY
unit Of Measure
Participant

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Preserved source evidence · Not medical advice