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NCT00154102 · OUTCOME

Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments

Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL) · Source last updated 2017-01-30

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

Measure
NUMBER
Unit
percentage participants
Interval / dispersion
95% Confidence Interval
Time frame
evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

What was measured

The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).

Analysis population: Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009

Groups in this outcome

Cetuximab Plus FOLFIRI

Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops

FOLFIRI Alone

Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops

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

Analysis denominator · Participants

GroupSource count
Cetuximab Plus FOLFIRI316
FOLFIRI Alone350

Reported measurements

Source class 1
Values in percentage participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cetuximab Plus FOLFIRI57.3Not reported51.662.8Not reported
FOLFIRI Alone39.7Not reported34.645.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.515
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.826
    group Description
    The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    2.069
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    1.515
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.826
    group Description
    The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    2.069
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.6
        upper Limit
        62.8
        value
        57.3
      2. group Id
        OG001
        lower Limit
        34.6
        upper Limit
        45.1
        value
        39.7
denoms
  1. counts
    1. group Id
      OG000
      value
      316
    2. group Id
      OG001
      value
      350
    units
    Participants
description
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).
dispersion Type
95% Confidence Interval
groups
  1. description
    Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
    id
    OG000
    title
    Cetuximab Plus FOLFIRI
  2. description
    Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
    id
    OG001
    title
    FOLFIRI Alone
param Type
NUMBER
population Description
Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009
reporting Status
POSTED
time Frame
evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
title
Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments
type
SECONDARY
unit Of Measure
percentage participants

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