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NCT00009737 · OUTCOME

Relapse-Free Survival

A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer · Source last updated 2016-06-22

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Approximately 3 years

What was measured

Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression.

Analysis population: All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.

Groups in this outcome

Capecitabine

Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).

5-Fluorouracil + Leucovorin

Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Capecitabine1004
5-Fluorouracil + Leucovorin983

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine677Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin621Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    0.041
    p Value Comment
    For difference between arms, \< 0.001 for non-inferiority
    param Type
    Hazard Ratio (HR)
    param Value
    0.86
    statistical Method
    Wald Chi-Square Test
    tested Non Inferiority
    true
Complete source fields
analyses
  1. ci Lower Limit
    0.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    0.041
    p Value Comment
    For difference between arms, \< 0.001 for non-inferiority
    param Type
    Hazard Ratio (HR)
    param Value
    0.86
    statistical Method
    Wald Chi-Square Test
    tested Non Inferiority
    true
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        677
      2. group Id
        OG001
        value
        621
denoms
  1. counts
    1. group Id
      OG000
      value
      1004
    2. group Id
      OG001
      value
      983
    units
    Participants
description
Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression.
groups
  1. description
    Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
    id
    OG000
    title
    Capecitabine
  2. description
    Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
    id
    OG001
    title
    5-Fluorouracil + Leucovorin
param Type
NUMBER
population Description
All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.
reporting Status
POSTED
time Frame
Approximately 3 years
title
Relapse-Free Survival
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice