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NCT00807768 · BASELINE

Baseline characteristics

Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer · Source last updated 2019-03-20

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
      301
    2. group Id
      BG001
      value
      300
    3. group Id
      BG002
      value
      601
    units
    Participants
groups
  1. description
    Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    id
    BG000
    title
    Arm I (Pelvic Radiation Therapy)
  2. description
    Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    id
    BG001
    title
    Arm II (Brachytherapy, Paclitaxel, Carboplatin)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          38
      title
      <50 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          95
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          167
      title
      50-59 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          137
        3. group Id
          BG002
          value
          252
      title
      60-69 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          144
      title
      >=70 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          301
        2. group Id
          BG001
          value
          300
        3. group Id
          BG002
          value
          601
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          50
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          106
      title
      Endometrioid, grade 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          212
      title
      Endometrioid, grade 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          126
      title
      Endometrioid, grade 3 or not graded
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          88
      title
      Serous
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          28
      title
      Clear Cell
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
      title
      Mixed
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
      title
      Other
    description
    Grade 1 endometrioid endometrial cancers are well differentiated. Grade 2 tumors are moderately differentiated. Grade 3 tumors are poorly differentiated. Lower grades have a higher relapse free survival rate..
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cell Type
    unit Of Measure
    Participants
population Description
Enrolled patients
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      301
    2. group Id
      BG001
      value
      300
    3. group Id
      BG002
      value
      601
    units
    Participants
groups
  1. description
    Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    id
    BG000
    title
    Arm I (Pelvic Radiation Therapy)
  2. description
    Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    id
    BG001
    title
    Arm II (Brachytherapy, Paclitaxel, Carboplatin)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          38
      title
      <50 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          95
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          167
      title
      50-59 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          137
        3. group Id
          BG002
          value
          252
      title
      60-69 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          144
      title
      >=70 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          301
        2. group Id
          BG001
          value
          300
        3. group Id
          BG002
          value
          601
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          50
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          106
      title
      Endometrioid, grade 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          212
      title
      Endometrioid, grade 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          126
      title
      Endometrioid, grade 3 or not graded
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          88
      title
      Serous
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          28
      title
      Clear Cell
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
      title
      Mixed
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
      title
      Other
    description
    Grade 1 endometrioid endometrial cancers are well differentiated. Grade 2 tumors are moderately differentiated. Grade 3 tumors are poorly differentiated. Lower grades have a higher relapse free survival rate..
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cell Type
    unit Of Measure
    Participants
population Description
Enrolled patients

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Preserved source evidence · Not medical advice