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NCT03189446 · FLOW

Participant flow

Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer · Source last updated 2024-03-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
    id
    FG000
    title
    Vaginal Cuff Brachytherapy + Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of 39 enrolled participants, 32 met inclusion criteria and evaluable then assign to the single arm treatment.
recruitment Details
Participants were recruited at a single institution from October 2017 to July 2019. The first patient was enrolled on October 2, 2017 and the last patient was enrolled on July 23, 2019
Complete source fields
groups
  1. description
    Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
    id
    FG000
    title
    Vaginal Cuff Brachytherapy + Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of 39 enrolled participants, 32 met inclusion criteria and evaluable then assign to the single arm treatment.
recruitment Details
Participants were recruited at a single institution from October 2017 to July 2019. The first patient was enrolled on October 2, 2017 and the last patient was enrolled on July 23, 2019

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Preserved source evidence · Not medical advice