Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00075582 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      305
    2. group Id
      BG001
      value
      85
    3. group Id
      BG002
      value
      390
    units
    Participants
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
    BG000
    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
    BG001
    title
    Regimen II (Chemotherapy, Radiotherapy, Surgery)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.81
          value
          7.69
        2. group Id
          BG001
          spread
          6.78
          value
          5.02
        3. group Id
          BG002
          spread
          6.13
          value
          7.11
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          143
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          217
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          247
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          48
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          228
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          293
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          33
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          47
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          255
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          326
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          17
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          346
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          26
      title
      Canada
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
      title
      Australia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Netherlands
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      New Zealand
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Puerto Rico
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
      title
      Switzerland
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      305
    2. group Id
      BG001
      value
      85
    3. group Id
      BG002
      value
      390
    units
    Participants
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
    BG000
    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
    BG001
    title
    Regimen II (Chemotherapy, Radiotherapy, Surgery)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.81
          value
          7.69
        2. group Id
          BG001
          spread
          6.78
          value
          5.02
        3. group Id
          BG002
          spread
          6.13
          value
          7.11
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          143
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          217
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          247
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          48
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          228
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          293
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          33
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          47
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          255
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          326
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          17
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          346
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          26
      title
      Canada
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
      title
      Australia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Netherlands
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      New Zealand
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Puerto Rico
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
      title
      Switzerland
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice