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NCT01535053 · FLOW

Participant flow

Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia · Source last updated 2022-08-12

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

groups
  1. description
    IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
    id
    FG000
    title
    Regimen I (Dactinomycin)
  2. description
    institutional preference of either: * IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR * IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
    id
    FG001
    title
    Regimen II (Methotrexate)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        28
      type
      STARTED
    2. achievements
      1. comment
        treated for 3 cycles after hCG \<5mIU/ml or until biologic,disease progression, unacceptable toxicity
        group Id
        FG000
        num Subjects
        28
      2. comment
        treated for 3 cycles after hCG \<5mIU/ml or until biologic,disease progression, unacceptable toxicity
        group Id
        FG001
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Sites declared in advance which of 2 methotrexate regimens they would follow for patients who received a random treatment allocation to the methotrexate arm. Randomization is stratified by country (US, Canada, Japan, Korea, Australia, United Kingdom, etc.) and Multi-day methotrexate regimen (8- or 5-day) used by the participating site.
recruitment Details
The study was activated on 6/18/2012and closed to accrual prematurely on 9/20/2016 by the sponsor due to slow accrual.
Complete source fields
groups
  1. description
    IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
    id
    FG000
    title
    Regimen I (Dactinomycin)
  2. description
    institutional preference of either: * IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR * IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
    id
    FG001
    title
    Regimen II (Methotrexate)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        28
      type
      STARTED
    2. achievements
      1. comment
        treated for 3 cycles after hCG \<5mIU/ml or until biologic,disease progression, unacceptable toxicity
        group Id
        FG000
        num Subjects
        28
      2. comment
        treated for 3 cycles after hCG \<5mIU/ml or until biologic,disease progression, unacceptable toxicity
        group Id
        FG001
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Sites declared in advance which of 2 methotrexate regimens they would follow for patients who received a random treatment allocation to the methotrexate arm. Randomization is stratified by country (US, Canada, Japan, Korea, Australia, United Kingdom, etc.) and Multi-day methotrexate regimen (8- or 5-day) used by the participating site.
recruitment Details
The study was activated on 6/18/2012and closed to accrual prematurely on 9/20/2016 by the sponsor due to slow accrual.

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Preserved source evidence · Not medical advice