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NCT00217737 · OUTCOME

Disease-free Survival Rate at 5 Years

Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer · Source last updated 2026-08-25

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

Measure
NUMBER
Unit
Proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization

What was measured

Disease-free survival (DFS) is defined as the time from randomization to the earlier of disease recurrence, new invasive primary cancer, or death from any cause. The Kaplan-Meier estimates were used to characterize the 5-year DFS rates.

Analysis population: Eligible patients who were registered or randomized at Step 2 were included in this analysis.

Groups in this outcome

Arm A (5-FU, Leucovorin, Oxaliplatin)

Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)

Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.

Arm C (Observation)

Patients undergo observation.

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

Analysis denominator · Participants

GroupSource count
Arm A (5-FU, Leucovorin, Oxaliplatin)424
Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)435
Arm C (Observation)998

Reported measurements

Source class 1
Values in Proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (5-FU, Leucovorin, Oxaliplatin)0.805Not reported0.7660.846Not reported
Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)0.833Not reported0.7960.871Not reported
Arm C (Observation)0.816Not reported0.7910.842Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.11
    estimate Comment
    Hazard ratio: Arm B/Arm A
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.83
Complete source fields
analyses
  1. ci Lower Limit
    0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.11
    estimate Comment
    Hazard ratio: Arm B/Arm A
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.83
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.766
        upper Limit
        0.846
        value
        0.805
      2. group Id
        OG001
        lower Limit
        0.796
        upper Limit
        0.871
        value
        0.833
      3. group Id
        OG002
        lower Limit
        0.791
        upper Limit
        0.842
        value
        0.816
denoms
  1. counts
    1. group Id
      OG000
      value
      424
    2. group Id
      OG001
      value
      435
    3. group Id
      OG002
      value
      998
    units
    Participants
description
Disease-free survival (DFS) is defined as the time from randomization to the earlier of disease recurrence, new invasive primary cancer, or death from any cause. The Kaplan-Meier estimates were used to characterize the 5-year DFS rates.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm A (5-FU, Leucovorin, Oxaliplatin)
  2. description
    Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)
  3. description
    Patients undergo observation.
    id
    OG002
    title
    Arm C (Observation)
param Type
NUMBER
population Description
Eligible patients who were registered or randomized at Step 2 were included in this analysis.
reporting Status
POSTED
time Frame
Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization
title
Disease-free Survival Rate at 5 Years
type
PRIMARY
unit Of Measure
Proportion of participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice