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NCT00154102 · OUTCOME

Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status

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 global health status 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 better QoL.

Analysis population: 1125 subjects (566 Cetuximab + FOLFIRI; 559 FOLFIRI alone) completed at least 1 evaluable questionnaire \& were included in the Evaluable for QLQ-C30 population. Numbers at each timepoint were (Cetuximab + FOLFORI/FOLFORI alone, respectively): baseline 430/423; Week 8 421/390; Week 16 312/309; Week 24 255/244; Week 32 164/154; Week 40 122/96

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 FOLFIRI58.881.185Not reportedNot reportedNot reported
FOLFIRI Alone60.331.155Not reportedNot reportedNot reported
At week 8
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Cetuximab Plus FOLFIRI59.021.187Not reportedNot reportedNot reported
FOLFIRI Alone61.831.176Not reportedNot reportedNot reported
At week 16
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Cetuximab Plus FOLFIRI60.771.276Not reportedNot reportedNot reported
FOLFIRI Alone63.291.249Not reportedNot reportedNot reported
At week 24
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Cetuximab Plus FOLFIRI61.831.368Not reportedNot reportedNot reported
FOLFIRI Alone64.061.364Not reportedNot reportedNot reported
At week 32
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Cetuximab Plus FOLFIRI59.681.590Not reportedNot reportedNot reported
FOLFIRI Alone65.071.612Not reportedNot reportedNot reported
At week 40
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Cetuximab Plus FOLFIRI63.431.835Not reportedNot reportedNot reported
FOLFIRI Alone64.021.991Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.185
        value
        58.88
      2. group Id
        OG001
        spread
        1.155
        value
        60.33
    title
    At baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.187
        value
        59.02
      2. group Id
        OG001
        spread
        1.176
        value
        61.83
    title
    At week 8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.276
        value
        60.77
      2. group Id
        OG001
        spread
        1.249
        value
        63.29
    title
    At week 16
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.368
        value
        61.83
      2. group Id
        OG001
        spread
        1.364
        value
        64.06
    title
    At week 24
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.590
        value
        59.68
      2. group Id
        OG001
        spread
        1.612
        value
        65.07
    title
    At week 32
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.835
        value
        63.43
      2. group Id
        OG001
        spread
        1.991
        value
        64.02
    title
    At week 40
denoms
  1. counts
    1. group Id
      OG000
      value
      566
    2. group Id
      OG001
      value
      559
    units
    Participants
description
Mean global health status 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 better QoL.
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 Cetuximab + FOLFIRI; 559 FOLFIRI alone) completed at least 1 evaluable questionnaire \& were included in the Evaluable for QLQ-C30 population. Numbers at each timepoint were (Cetuximab + FOLFORI/FOLFORI alone, respectively): baseline 430/423; Week 8 421/390; Week 16 312/309; Week 24 255/244; Week 32 164/154; Week 40 122/96
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 (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
type
SECONDARY
unit Of Measure
scores on a scale

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

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