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NCT00154102 · OUTCOME

Quality of Life Assessment (EORTC QLQ-C30) Social Functioning

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
LEAST_SQUARES_MEAN
Unit
scores on a scale
Interval / dispersion
Standard Error
Time frame
at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

What was measured

Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.

Analysis population: 1125 subjects (566 in the Cetuximab + FOLFIRI arm and 559 in the FOLFIRI alone arm) completed at least one evaluable QLQ-C30 questionnaire and were thus included in the Evaluable for QLQ-C30 population

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 FOLFIRI566
FOLFIRI Alone559

Reported measurements

At baseline
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Cetuximab Plus FOLFIRI75.211.426Not reportedNot reportedNot reported
FOLFIRI Alone77.281.395Not reportedNot reportedNot reported
At week 8
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Cetuximab Plus FOLFIRI74.141.430Not reportedNot reportedNot reported
FOLFIRI Alone76.711.415Not reportedNot reportedNot reported
At week 16
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Cetuximab Plus FOLFIRI73.721.533Not reportedNot reportedNot reported
FOLFIRI Alone76.671.498Not reportedNot reportedNot reported
At week 24
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Cetuximab Plus FOLFIRI76.311.644Not reportedNot reportedNot reported
FOLFIRI Alone77.981.633Not reportedNot reportedNot reported
At week 32
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Cetuximab Plus FOLFIRI74.041.903Not reportedNot reportedNot reported
FOLFIRI Alone75.641.933Not reportedNot reportedNot reported
At week 40
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Cetuximab Plus FOLFIRI76.582.198Not reportedNot reportedNot reported
FOLFIRI Alone78.072.388Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.426
        value
        75.21
      2. group Id
        OG001
        spread
        1.395
        value
        77.28
    title
    At baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.430
        value
        74.14
      2. group Id
        OG001
        spread
        1.415
        value
        76.71
    title
    At week 8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.533
        value
        73.72
      2. group Id
        OG001
        spread
        1.498
        value
        76.67
    title
    At week 16
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.644
        value
        76.31
      2. group Id
        OG001
        spread
        1.633
        value
        77.98
    title
    At week 24
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.903
        value
        74.04
      2. group Id
        OG001
        spread
        1.933
        value
        75.64
    title
    At week 32
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.198
        value
        76.58
      2. group Id
        OG001
        spread
        2.388
        value
        78.07
    title
    At week 40
denoms
  1. counts
    1. group Id
      OG000
      value
      566
    2. group Id
      OG001
      value
      559
    units
    Participants
description
Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.
dispersion Type
Standard Error
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
LEAST_SQUARES_MEAN
population Description
1125 subjects (566 in the Cetuximab + FOLFIRI arm and 559 in the FOLFIRI alone arm) completed at least one evaluable QLQ-C30 questionnaire and were thus included in the Evaluable for QLQ-C30 population
reporting Status
POSTED
time Frame
at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
title
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
type
SECONDARY
unit Of Measure
scores on a scale

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