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NCT00807768 · FLOW

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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.

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
    FG000
    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
    FG001
    title
    Arm II (Brachytherapy, Paclitaxel, Carboplatin)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        301
      2. group Id
        FG001
        num Subjects
        300
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        301
      2. group Id
        FG001
        num Subjects
        300
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
GOG 0249 accrued 601 patients from March 2009 to February 2013.
Complete source fields
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
    FG000
    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
    FG001
    title
    Arm II (Brachytherapy, Paclitaxel, Carboplatin)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        301
      2. group Id
        FG001
        num Subjects
        300
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        301
      2. group Id
        FG001
        num Subjects
        300
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
GOG 0249 accrued 601 patients from March 2009 to February 2013.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice