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NCT00433550 · FLOW

Participant flow

Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer · Source last updated 2017-08-24

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

groups
  1. description
    Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    FG000
    title
    Group 1 (6/6 UGT1A1 Genotype)
  2. description
    Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    FG001
    title
    Group 2 (6/7 UGT1A1 Genotype)
  3. description
    Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    FG002
    title
    Group 3 (7/7 UGT1A1 Genotype)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Prior to registration, patients were tested for UGT1A1 TA indel genotype of 6/6, 6/7, or 7/7. Patients were grouped into one of three treatment groups depending on UGT1A1 genotype. All other genotypes were ineligible. The endpoints of this study are not to compare results between the UGT1A1 types, but to analyze as one combined cohort.
Complete source fields
groups
  1. description
    Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    FG000
    title
    Group 1 (6/6 UGT1A1 Genotype)
  2. description
    Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    FG001
    title
    Group 2 (6/7 UGT1A1 Genotype)
  3. description
    Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    FG002
    title
    Group 3 (7/7 UGT1A1 Genotype)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Prior to registration, patients were tested for UGT1A1 TA indel genotype of 6/6, 6/7, or 7/7. Patients were grouped into one of three treatment groups depending on UGT1A1 genotype. All other genotypes were ineligible. The endpoints of this study are not to compare results between the UGT1A1 types, but to analyze as one combined cohort.

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

Preserved source evidence · Not medical advice