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NCT02912559 · OUTCOME

Disease Free Survival (DFS)

Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair · Source last updated 2026-10-01

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
3 years

What was measured

DFS will be compared between treatment arms using the stratified log rank test at one-sided level 0.025. If zero DFS events are observed in a certain stratum at an interim analysis and unstratified log-rank is used, all subsequent analyses for DFS will use unstratified log-rank test. The hazard ratio (HR) for DFS will be estimated using a stratified Cox proportional hazards model and the 95 percent confidence interval (CI) for the HR will be provided. Results from an unstratified analysis will also be provided. Kaplan-Meier methodology will be used to estimate the median DFS for each treatment arm, and Kaplan-Meier curves will be produced. Brookmeyer Crowley methodology will be used to construct the 95 percent CI for the median DFS for each treatment arm.

Groups in this outcome

Arm I (Combination Chemotherapy, Atezolizumab)

Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial. \> \> Atezolizumab: Given IV \> \> Biospecimen Collection: Undergo blood sample collection \> \> Computed Tomography: Undergo CT \> \> Fluorouracil: Given IV \> \> Leucovorin Calcium: Given IV \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Oxaliplatin: Given IV \> \> Quality-of-Life Assessment: Ancillary studies

Arm II (Combination Chemotherapy)

Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial. \> \> Biospecimen Collection: Undergo blood sample collection \> \> Computed Tomography: Undergo CT \> \> Fluorouracil: Given IV \> \> Leucovorin Calcium: Given IV \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Oxaliplatin: Given IV \> \> Quality-of-Life Assessment: Ancillary studies

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 I (Combination Chemotherapy, Atezolizumab)355
Arm II (Combination Chemotherapy)357

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Combination Chemotherapy, Atezolizumab)86.3Not reported81.889.8Not reported
Arm II (Combination Chemotherapy)76.2Not reported70.980.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.35
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.73
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Method
    Stratified Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.35
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.73
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Method
    Stratified Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        81.8
        upper Limit
        89.8
        value
        86.3
      2. group Id
        OG001
        lower Limit
        70.9
        upper Limit
        80.6
        value
        76.2
denoms
  1. counts
    1. group Id
      OG000
      value
      355
    2. group Id
      OG001
      value
      357
    units
    Participants
description
DFS will be compared between treatment arms using the stratified log rank test at one-sided level 0.025. If zero DFS events are observed in a certain stratum at an interim analysis and unstratified log-rank is used, all subsequent analyses for DFS will use unstratified log-rank test. The hazard ratio (HR) for DFS will be estimated using a stratified Cox proportional hazards model and the 95 percent confidence interval (CI) for the HR will be provided. Results from an unstratified analysis will also be provided. Kaplan-Meier methodology will be used to estimate the median DFS for each treatment arm, and Kaplan-Meier curves will be produced. Brookmeyer Crowley methodology will be used to construct the 95 percent CI for the median DFS for each treatment arm.
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, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial. \> \> Atezolizumab: Given IV \> \> Biospecimen Collection: Undergo blood sample collection \> \> Computed Tomography: Undergo CT \> \> Fluorouracil: Given IV \> \> Leucovorin Calcium: Given IV \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Oxaliplatin: Given IV \> \> Quality-of-Life Assessment: Ancillary studies
    id
    OG000
    title
    Arm I (Combination Chemotherapy, Atezolizumab)
  2. description
    Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial. \> \> Biospecimen Collection: Undergo blood sample collection \> \> Computed Tomography: Undergo CT \> \> Fluorouracil: Given IV \> \> Leucovorin Calcium: Given IV \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Oxaliplatin: Given IV \> \> Quality-of-Life Assessment: Ancillary studies
    id
    OG001
    title
    Arm II (Combination Chemotherapy)
param Type
NUMBER
reporting Status
POSTED
time Frame
3 years
title
Disease Free Survival (DFS)
type
PRIMARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7

Preserved source evidence · Not medical advice