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NCT01533207 · FLOW

Participant flow

Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery · Source last updated 2020-04-28

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

groups
  1. description
    Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
    id
    FG000
    title
    Regimen 1
  2. description
    Observation
    id
    FG001
    title
    Regimen II
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        18
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        18
      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
This study accrued 38 patients from June 2012 to September, 2016. Study was closed due to accrual futility.
Complete source fields
groups
  1. description
    Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
    id
    FG000
    title
    Regimen 1
  2. description
    Observation
    id
    FG001
    title
    Regimen II
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        18
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        18
      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
This study accrued 38 patients from June 2012 to September, 2016. Study was closed due to accrual futility.

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Preserved source evidence · Not medical advice