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NCT00231842 · FLOW

Participant flow

Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus · Source last updated 2019-01-23

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

groups
  1. description
    Participants with surgically staged carcinosarcoma (CS) with no gross residual disease were initially administered ifosfamide (1.2 g/m2/day for 5 days) with cisplatin (20 mg/m2/day for 5 days) every 3 weeks for 3 cycles followed by pelvic external beam RT and brachytherapy followed by 3 additional cycles of ifosfamide (1.0 g/m2/day) with cisplatin with cisplatin (20 mg/m2/day for 5 days) evrey 3 weeks. cisplatin added toxicity without additional efficacy, so mid-study, cisplatin was eliminated.
    id
    FG000
    title
    Chemotherapy and Radiation Therapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Did not complete the last 3 cycle
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        30
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      Initiated Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      comment
      27 participants completed the first 3 cycles of chemotherapy followed by RT
      type
      Completed First 3 Cycles
    4. achievements
      1. group Id
        FG000
        num Subjects
        27
      comment
      26 participants had EBRT + Brachytherapy; 1 had EBRT alone
      type
      Completed Prescribed RT
    5. achievements
      1. group Id
        FG000
        num Subjects
        19
      type
      Completed Full Prescribed Therapy
    6. achievements
      1. group Id
        FG000
        num Subjects
        19
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
30 participants were enrolled and 3 participants withdrew prior to therapy. Twenty-seven participants received the first three cycles of chemotherapy and Radiation Therapy and were included in the analysis.
recruitment Details
Eligible participants with surgically staged I-IV uterine carcinosarcoma (CS) without evidence of gross residual disease after primary surgery were recruited from 1999 to 2009 . Eligible participants underwent surgical staging when clinically indicated.
Complete source fields
groups
  1. description
    Participants with surgically staged carcinosarcoma (CS) with no gross residual disease were initially administered ifosfamide (1.2 g/m2/day for 5 days) with cisplatin (20 mg/m2/day for 5 days) every 3 weeks for 3 cycles followed by pelvic external beam RT and brachytherapy followed by 3 additional cycles of ifosfamide (1.0 g/m2/day) with cisplatin with cisplatin (20 mg/m2/day for 5 days) evrey 3 weeks. cisplatin added toxicity without additional efficacy, so mid-study, cisplatin was eliminated.
    id
    FG000
    title
    Chemotherapy and Radiation Therapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Did not complete the last 3 cycle
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        30
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      Initiated Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      comment
      27 participants completed the first 3 cycles of chemotherapy followed by RT
      type
      Completed First 3 Cycles
    4. achievements
      1. group Id
        FG000
        num Subjects
        27
      comment
      26 participants had EBRT + Brachytherapy; 1 had EBRT alone
      type
      Completed Prescribed RT
    5. achievements
      1. group Id
        FG000
        num Subjects
        19
      type
      Completed Full Prescribed Therapy
    6. achievements
      1. group Id
        FG000
        num Subjects
        19
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
30 participants were enrolled and 3 participants withdrew prior to therapy. Twenty-seven participants received the first three cycles of chemotherapy and Radiation Therapy and were included in the analysis.
recruitment Details
Eligible participants with surgically staged I-IV uterine carcinosarcoma (CS) without evidence of gross residual disease after primary surgery were recruited from 1999 to 2009 . Eligible participants underwent surgical staging when clinically indicated.

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Preserved source evidence · Not medical advice