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NCT00941070 · BASELINE

Baseline characteristics

Triapine, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer or Vaginal Cancer · Source last updated 2017-11-17

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
      26
    units
    Participants
groups
  1. description
    Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated. Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.
    id
    BG000
    title
    Treatment (Cisplatin, Triapine, Radiation Therapy)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      30-39
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      40-49
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      50-59
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      60-69
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      70-79
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        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
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          24
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          18
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      1
    description
    One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics. The Gynecologic Oncology Group (GOG) performance status reflects individual daily living activities on a scale of 0 (fully active with symptoms) to 5 (dead).
    param Type
    NUMBER
    title
    GOG Performance Status
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      title
      Squamous cell carcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Adenosquamous carcinoma
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Adenocarcinoma
    description
    One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
    param Type
    NUMBER
    title
    Histopathology
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Grade 2
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Grade 3
    description
    One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
    param Type
    NUMBER
    title
    Tumor Grade
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Less than 2/3rds invasion
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      2/3rds or greater invasion
    description
    One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
    param Type
    NUMBER
    title
    Cervical Stromal Invasion
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Absent
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Present
    description
    One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
    param Type
    NUMBER
    title
    Lymphovascular invasion
    unit Of Measure
    participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cervix IB2 Node Negative
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Cervix IB2 Node Positive
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Cervix IIA
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cervix IIB
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Cervix IIIB
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Cervix IVB
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Vagina II
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Vagina IVA
    description
    One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
    param Type
    NUMBER
    title
    International Federation of Gynecology and Obstetrics (FIGO) Stage
    unit Of Measure
    participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      HPV 16
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      HPV 18
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      HPV-naive
    description
    Cervical cancer genotyping
    param Type
    NUMBER
    title
    HPV Genotyping
    unit Of Measure
    participants
population Description
Baseline demographic characteristics include all 26 patients. Study specific characteristics only include the 25 patients that received treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      26
    units
    Participants
groups
  1. description
    Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated. Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.
    id
    BG000
    title
    Treatment (Cisplatin, Triapine, Radiation Therapy)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      30-39
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      40-49
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      50-59
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      60-69
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      70-79
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        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
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          24
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          18
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      1
    description
    One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics. The Gynecologic Oncology Group (GOG) performance status reflects individual daily living activities on a scale of 0 (fully active with symptoms) to 5 (dead).
    param Type
    NUMBER
    title
    GOG Performance Status
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      title
      Squamous cell carcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Adenosquamous carcinoma
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Adenocarcinoma
    description
    One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
    param Type
    NUMBER
    title
    Histopathology
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Grade 2
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Grade 3
    description
    One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
    param Type
    NUMBER
    title
    Tumor Grade
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Less than 2/3rds invasion
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      2/3rds or greater invasion
    description
    One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
    param Type
    NUMBER
    title
    Cervical Stromal Invasion
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Absent
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Present
    description
    One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
    param Type
    NUMBER
    title
    Lymphovascular invasion
    unit Of Measure
    participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cervix IB2 Node Negative
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Cervix IB2 Node Positive
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Cervix IIA
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Cervix IIB
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Cervix IIIB
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Cervix IVB
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Vagina II
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Vagina IVA
    description
    One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
    param Type
    NUMBER
    title
    International Federation of Gynecology and Obstetrics (FIGO) Stage
    unit Of Measure
    participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      HPV 16
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      HPV 18
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      HPV-naive
    description
    Cervical cancer genotyping
    param Type
    NUMBER
    title
    HPV Genotyping
    unit Of Measure
    participants
population Description
Baseline demographic characteristics include all 26 patients. Study specific characteristics only include the 25 patients that received treatment.

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