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Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL) (CRYSTAL)

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ClinicalTrials.gov Identifier: NCT00154102
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : February 23, 2011
Last Update Posted : January 30, 2017
Sponsor:
Information provided by:
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer
Interventions Drug: Cetuximab
Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
Enrollment 1221
Recruitment Details

First/Last subject in: 10 Aug 2004/4 Nov 2005. Clinical cut-off efficacy analyses except survival: 27 Jul 2006, Cut off date IRC data: 14 Dec 2006; cut-off safety analyses: 30 Nov 2007; cut-off survival analyses: 31 May 2009; cut-off KRAS analyses: 28 Aug 2009.

1221 subjects were randomised or treated, of whom 1198 were randomised and treated.
Pre-assignment Details

At the prescreening visit the subject completed the first informed consent form, and a sample of tumor tissue for determination of EGFR expression was to be obtained.

The screening (baseline) visit was performed no more than 21 days before randomization. EGFR-expressing subjects completed a second informed consent form to participate in the study.
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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 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
Period Title: Overall Study
Started 599 [1] 599 [2]
Completed 592 597
Not Completed 7 2
Reason Not Completed
investigational study phase ongoing             7             2
[1]
Randomized and treated subjects; 1 additional subject was treated but not randomised
[2]
Randomized and treated subjects; 3 additional subjects were treated but not randomised
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone Total
Hide Arm/Group 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 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 Total of all reporting groups
Overall Number of Baseline Participants 599 599 1198
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 599 participants 599 participants 1198 participants
60.0  (10.52) 59.8  (11.06) 59.9  (10.79)
[1]
Measure Description: Age missing for 1 subject
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 599 participants 599 participants 1198 participants
Missing 1 0 1
Between 18 and 65 years 374 377 751
>=65 years 224 222 446
[1]
Measure Description: Age missing for 1 subject
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 599 participants 599 participants 1198 participants
Female
230
  38.4%
243
  40.6%
473
  39.5%
Male
369
  61.6%
356
  59.4%
725
  60.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 599 participants 599 participants 1198 participants
Western Europe 262 267 529
Eastern Europe 203 201 404
Rest of the World 134 131 265
1.Primary Outcome
Title Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments
Hide Description

Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Time Frame Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis on Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 599 599
Median (95% Confidence Interval)
Unit of Measure: months
8.9
(8.0 to 9.4)
8.0
(7.6 to 9.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab Plus FOLFIRI, FOLFIRI Alone
Comments The study was planned with 633 progression events, in order to provide 80% power to test the null hypothesis of no difference in PFS time between treatment groups, assuming a hazard ratio (HR) of 0.8 of cetuximab + chemotherapy (CTX) over CTX alone. Significance level was fixed at 5%. The two-sided stratified log-rank test was employed, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and Karnovsky Performance Scale (KPS):<80 vs. ≥80)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0479
Comments [Not Specified]
Method Stratified log rank
Comments Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.853
Confidence Interval (2-Sided) 95%
0.728 to 1.000
Estimation Comments [Not Specified]
2.Primary Outcome
Title Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments
Hide Description

Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Time Frame Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 316 350
Median (95% Confidence Interval)
Unit of Measure: months
9.9
(9.0 to 11.3)
8.4
(7.4 to 9.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab Plus FOLFIRI, FOLFIRI Alone
Comments The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Stratified log rank
Comments Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.696
Confidence Interval (2-Sided) 95%
0.558 to 0.867
Estimation Comments [Not Specified]
3.Primary Outcome
Title Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
Hide Description

Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Time Frame Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 214 183
Median (95% Confidence Interval)
Unit of Measure: months
7.4
(6.1 to 8.0)
7.7
(7.3 to 9.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab Plus FOLFIRI, FOLFIRI Alone
Comments The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2648
Comments [Not Specified]
Method Stratified log rank
Comments Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.171
Confidence Interval (2-Sided) 95%
0.887 to 1.544
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Overall Survival Time (OS)
Hide Description Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.
Time Frame Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (allocation to treatment groups as randomized and treated)
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 599 599
Median (95% Confidence Interval)
Unit of Measure: months
19.9
(18.5 to 21.3)
18.6
(16.7 to 19.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab Plus FOLFIRI, FOLFIRI Alone
Comments The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0419
Comments [Not Specified]
Method Stratified log rank
Comments Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.878
Confidence Interval (2-Sided) 95%
0.774 to 0.995
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Overall Survival Time (KRAS Wild-Type Population)
Hide Description Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.
Time Frame Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 316 350
Median (95% Confidence Interval)
Unit of Measure: months
23.5
(21.2 to 26.3)
20.0
(17.4 to 21.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab Plus FOLFIRI, FOLFIRI Alone
Comments The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0093
Comments [Not Specified]
Method Stratified log rank
Comments Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.796
Confidence Interval (2-Sided) 95%
0.670 to 0.946
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Overall Survival Time (KRAS Mutant Population)
Hide Description Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.
Time Frame Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 214 183
Median (95% Confidence Interval)
Unit of Measure: months
16.2
(14.9 to 17.9)
16.7
(14.9 to 19.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab Plus FOLFIRI, FOLFIRI Alone
Comments The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7549
Comments [Not Specified]
Method Stratified log rank
Comments Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.035
Confidence Interval (2-Sided) 95%
0.834 to 1.284
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Best Overall Response Rate - Independent Review Committee (IRC) Assessments
Hide 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).
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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (allocation to treatment groups as randomized and treated)
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 599 599
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46.9
(42.9 to 51.0)
38.7
(34.8 to 42.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab Plus FOLFIRI, FOLFIRI Alone
Comments 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)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments [Not Specified]
Method Stratified cochran-mantel haenszel test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.40
Confidence Interval (2-Sided) 95%
1.12 to 1.77
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments
Hide 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).
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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 316 350
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage participants
57.3
(51.6 to 62.8)
39.7
(34.6 to 45.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab Plus FOLFIRI, FOLFIRI Alone
Comments 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)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.069
Confidence Interval (2-Sided) 95%
1.515 to 2.826
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
Hide 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).
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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 214 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.3
(25.2 to 38.0)
36.1
(29.1 to 43.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab Plus FOLFIRI, FOLFIRI Alone
Comments 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)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3475
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.822
Confidence Interval (2-Sided) 95%
0.544 to 1.242
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Disease Control Rate - Independent Review Committee (IRC) Assessments
Hide Description The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).
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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (allocation to treatment groups as randomized and treated)
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 599 599
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.3
(81.1 to 87.1)
85.5
(82.4 to 88.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab Plus FOLFIRI, FOLFIRI Alone
Comments 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)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6004
Comments [Not Specified]
Method Stratified cochran-mantel haenszel test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.67 to 1.26
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Duration of Response - Independent Review Committee (IRC) Assessments
Hide Description

Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).

Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.
Time Frame Time from first assessment of complete response or partial response to disease progression, death or last tumor assessment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
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ITT population (allocation to treatment groups as randomized and treated)
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 599 599
Median (95% Confidence Interval)
Unit of Measure: months
9.6
(9.1 to 12.9)
7.7
(6.7 to 8.3)
12.Secondary Outcome
Title Participants With No Residual Tumor After Metastatic Surgery
Hide Description Participants with no residual tumor after on-study surgery for metastases
Time Frame time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007
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Hide Analysis Population Description
ITT population (allocation to treatment groups as randomized and treated)
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 599 599
Measure Type: Number
Unit of Measure: Participants
29 10
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab Plus FOLFIRI, FOLFIRI Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.02
Confidence Interval (2-Sided) 95%
1.45 to 6.27
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
Hide 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.
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
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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
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 566 559
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
At baseline 58.88  (1.185) 60.33  (1.155)
At week 8 59.02  (1.187) 61.83  (1.176)
At week 16 60.77  (1.276) 63.29  (1.249)
At week 24 61.83  (1.368) 64.06  (1.364)
At week 32 59.68  (1.590) 65.07  (1.612)
At week 40 63.43  (1.835) 64.02  (1.991)
14.Secondary Outcome
Title Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
Hide 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.
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
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Hide Analysis 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
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 566 559
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
At baseline 75.21  (1.426) 77.28  (1.395)
At week 8 74.14  (1.430) 76.71  (1.415)
At week 16 73.72  (1.533) 76.67  (1.498)
At week 24 76.31  (1.644) 77.98  (1.633)
At week 32 74.04  (1.903) 75.64  (1.933)
At week 40 76.58  (2.198) 78.07  (2.388)
15.Secondary Outcome
Title Safety - Number of Patients Experiencing Any Adverse Event
Hide Description Please refer to Adverse Events section for further details
Time Frame time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007
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Hide Analysis Population Description
Safety Population
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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
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
Overall Number of Participants Analyzed 600 602
Measure Type: Number
Unit of Measure: participants
599 597
Time Frame Time from first dose up to 30 days after the last dose of study treatment.
Adverse Event Reporting Description Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
 
Arm/Group Title Cetuximab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group 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.

Safety population: includes all treated subjects.

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.

Safety population: includes all treated subjects
All-Cause Mortality
Cetuximab Plus FOLFIRI FOLFIRI Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cetuximab Plus FOLFIRI FOLFIRI Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   263/600 (43.83%)   204/602 (33.89%) 
Blood and lymphatic system disorders     
ANAEMIA † 1  2/600 (0.33%)  8/602 (1.33%) 
FEBRILE BONE MARROW APLASIA † 1  1/600 (0.17%)  0/602 (0.00%) 
FEBRILE NEUTROPENIA † 1  16/600 (2.67%)  13/602 (2.16%) 
LEUKOPENIA † 1  6/600 (1.00%)  7/602 (1.16%) 
LYMPHOPENIA † 1  1/600 (0.17%)  0/602 (0.00%) 
NEUTROPENIA † 1  37/600 (6.17%)  35/602 (5.81%) 
PANCYTOPENIA † 1  1/600 (0.17%)  2/602 (0.33%) 
PLATELET TOXICITY † 1  0/600 (0.00%)  1/602 (0.17%) 
THROMBOCYTOPENIA † 1  3/600 (0.50%)  1/602 (0.17%) 
Cardiac disorders     
ACUTE CORONARY SYNDROME † 1  0/600 (0.00%)  1/602 (0.17%) 
ACUTE MYOCARDIAL INFARCTION † 1  3/600 (0.50%)  0/602 (0.00%) 
ANGINA PECTORIS † 1  2/600 (0.33%)  0/602 (0.00%) 
ARRHYTHMIA † 1  1/600 (0.17%)  0/602 (0.00%) 
ARRHYTHMIA SUPRAVENTRICULAR † 1  0/600 (0.00%)  1/602 (0.17%) 
ARTERIOSPASM CORONARY † 1  0/600 (0.00%)  1/602 (0.17%) 
ATRIAL FIBRILLATION † 1  3/600 (0.50%)  2/602 (0.33%) 
CARDIAC ARREST † 1  3/600 (0.50%)  1/602 (0.17%) 
CARDIAC FAILURE † 1  1/600 (0.17%)  0/602 (0.00%) 
CARDIAC FAILURE ACUTE † 1  1/600 (0.17%)  0/602 (0.00%) 
CARDIAC FAILURE CONGESTIVE † 1  1/600 (0.17%)  0/602 (0.00%) 
CARDIOGENIC SHOCK † 1  1/600 (0.17%)  0/602 (0.00%) 
CARDIOPULMONARY FAILURE † 1  1/600 (0.17%)  0/602 (0.00%) 
CONDUCTION DISORDER † 1  0/600 (0.00%)  1/602 (0.17%) 
MYOCARDIAL INFARCTION † 1  3/600 (0.50%)  1/602 (0.17%) 
MYOCARDIAL ISCHAEMIA † 1  3/600 (0.50%)  1/602 (0.17%) 
PALPITATIONS † 1  1/600 (0.17%)  0/602 (0.00%) 
RIGHT VENTRICULAR FAILURE † 1  0/600 (0.00%)  1/602 (0.17%) 
TACHYCARDIA † 1  1/600 (0.17%)  0/602 (0.00%) 
ACUTE CARDIO-VASCULAR INSUFFICIENCY † 1 [1]  0/600 (0.00%)  1/602 (0.17%) 
CIRCULATORY INSUFFICIENCY † 1 [1]  1/600 (0.17%)  0/602 (0.00%) 
Ear and labyrinth disorders     
VERTIGO † 1  1/600 (0.17%)  0/602 (0.00%) 
Endocrine disorders     
DIABETES INSIPIDUS † 1  1/600 (0.17%)  0/602 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL HERNIA † 1  1/600 (0.17%)  0/602 (0.00%) 
ABDOMINAL PAIN † 1  14/600 (2.33%)  13/602 (2.16%) 
ABDOMINAL PAIN UPPER † 1  3/600 (0.50%)  2/602 (0.33%) 
ACUTE ABDOMEN † 1  0/600 (0.00%)  1/602 (0.17%) 
ANAL FISTULA † 1  1/600 (0.17%)  0/602 (0.00%) 
ASCITES † 1  1/600 (0.17%)  3/602 (0.50%) 
COLONIC OBSTRUCTION † 1  1/600 (0.17%)  2/602 (0.33%) 
CONSTIPATION † 1  6/600 (1.00%)  2/602 (0.33%) 
DIARRHOEA † 1  36/600 (6.00%)  21/602 (3.49%) 
DYSPHAGIA † 1  1/600 (0.17%)  0/602 (0.00%) 
ENTEROCOLITIS † 1  1/600 (0.17%)  0/602 (0.00%) 
ENTEROVESICAL FISTULA † 1  1/600 (0.17%)  0/602 (0.00%) 
GASTRIC ULCER † 1  1/600 (0.17%)  0/602 (0.00%) 
GASTRO-INTESTINAL FISTULA † 1  1/600 (0.17%)  0/602 (0.00%) 
GASTROINTESTINAL HAEMORRHAGE † 1  1/600 (0.17%)  2/602 (0.33%) 
GASTROINTESTINAL HYPOMOTILITY † 1  1/600 (0.17%)  0/602 (0.00%) 
GASTROINTESTINAL OBSTRUCTION † 1  1/600 (0.17%)  0/602 (0.00%) 
HAEMATEMESIS † 1  2/600 (0.33%)  0/602 (0.00%) 
HAEMATOCHEZIA † 1  2/600 (0.33%)  0/602 (0.00%) 
ILEUS † 1  10/600 (1.67%)  7/602 (1.16%) 
ILEUS PARALYTIC † 1  0/600 (0.00%)  1/602 (0.17%) 
INGUINAL HERNIA † 1  1/600 (0.17%)  0/602 (0.00%) 
INTESTINAL HAEMORRHAGE † 1  1/600 (0.17%)  0/602 (0.00%) 
INTESTINAL OBSTRUCTION † 1  7/600 (1.17%)  8/602 (1.33%) 
INTESTINAL PERFORATION † 1  1/600 (0.17%)  0/602 (0.00%) 
MESENTERIC VEIN THROMBOSIS † 1  1/600 (0.17%)  0/602 (0.00%) 
NAUSEA † 1  8/600 (1.33%)  5/602 (0.83%) 
PANCREATITIS † 1  1/600 (0.17%)  0/602 (0.00%) 
PERITONEAL EFFUSION † 1  0/600 (0.00%)  1/602 (0.17%) 
PERITONITIS † 1  0/600 (0.00%)  2/602 (0.33%) 
PROCTALGIA † 1  1/600 (0.17%)  0/602 (0.00%) 
RECTAL HAEMORRHAGE † 1  0/600 (0.00%)  4/602 (0.66%) 
SMALL INTESTINAL OBSTRUCTION † 1  2/600 (0.33%)  2/602 (0.33%) 
STOMATITIS † 1  0/600 (0.00%)  1/602 (0.17%) 
SUBILEUS † 1  2/600 (0.33%)  8/602 (1.33%) 
UPPER GASTROINTESTINAL HAEMORRHAGE † 1  1/600 (0.17%)  0/602 (0.00%) 
VOMITING † 1  15/600 (2.50%)  16/602 (2.66%) 
General disorders     
ASTHENIA † 1  6/600 (1.00%)  5/602 (0.83%) 
CATHETER RELATED COMPLICATION † 1  1/600 (0.17%)  2/602 (0.33%) 
CATHETER SITE HAEMATOMA † 1  0/600 (0.00%)  1/602 (0.17%) 
CATHETER SITE INFLAMMATION † 1  2/600 (0.33%)  0/602 (0.00%) 
CATHETER SITE PAIN † 1  1/600 (0.17%)  0/602 (0.00%) 
CHEST PAIN † 1  3/600 (0.50%)  2/602 (0.33%) 
CHILLS † 1  5/600 (0.83%)  2/602 (0.33%) 
DEATH † 1  2/600 (0.33%)  0/602 (0.00%) 
DISEASE PROGRESSION † 1  1/600 (0.17%)  0/602 (0.00%) 
EXTRAVASATION † 1  1/600 (0.17%)  0/602 (0.00%) 
FATIGUE † 1  1/600 (0.17%)  8/602 (1.33%) 
GENERAL PHYSICAL HEALTH DETERIORATION † 1  4/600 (0.67%)  1/602 (0.17%) 
INFLAMMATION † 1  1/600 (0.17%)  0/602 (0.00%) 
INFLUENZA LIKE ILLNESS † 1  0/600 (0.00%)  1/602 (0.17%) 
INFUSION SITE EXTRAVASATION † 1  0/600 (0.00%)  1/602 (0.17%) 
INFUSION SITE PAIN † 1  0/600 (0.00%)  1/602 (0.17%) 
LOCALISED OEDEMA † 1  1/600 (0.17%)  0/602 (0.00%) 
MUCOSAL INFLAMMATION † 1  0/600 (0.00%)  1/602 (0.17%) 
MULTI-ORGAN FAILURE † 1  0/600 (0.00%)  1/602 (0.17%) 
OEDEMA PERIPHERAL † 1  3/600 (0.50%)  2/602 (0.33%) 
PYREXIA † 1  26/600 (4.33%)  21/602 (3.49%) 
THROMBUS//CLOT IN VEIN OF LEFT HAND CAUSING INFECTION † 1 [1]  1/600 (0.17%)  0/602 (0.00%) 
Hepatobiliary disorders     
BILE DUCT STENOSIS † 1  1/600 (0.17%)  0/602 (0.00%) 
BILIARY FISTULA † 1  1/600 (0.17%)  0/602 (0.00%) 
CHOLANGITIS † 1  0/600 (0.00%)  1/602 (0.17%) 
CHOLECYSTITIS † 1  1/600 (0.17%)  1/602 (0.17%) 
CHOLECYSTITIS ACUTE † 1  0/600 (0.00%)  1/602 (0.17%) 
DILATATION INTRAHEPATIC DUCT ACQUIRED † 1  0/600 (0.00%)  1/602 (0.17%) 
HEPATIC FAILURE † 1  1/600 (0.17%)  1/602 (0.17%) 
HYPERBILIRUBINAEMIA † 1  1/600 (0.17%)  1/602 (0.17%) 
JAUNDICE † 1  1/600 (0.17%)  2/602 (0.33%) 
Immune system disorders     
ANAPHYLACTIC REACTION † 1  3/600 (0.50%)  0/602 (0.00%) 
HYPERSENSITIVITY † 1  4/600 (0.67%)  0/602 (0.00%) 
Infections and infestations     
ABDOMINAL ABSCESS † 1  1/600 (0.17%)  0/602 (0.00%) 
ABDOMINAL INFECTION † 1  1/600 (0.17%)  0/602 (0.00%) 
ABSCESS † 1  1/600 (0.17%)  0/602 (0.00%) 
ABSCESS INTESTINAL † 1  1/600 (0.17%)  0/602 (0.00%) 
APPENDICITIS † 1  0/600 (0.00%)  1/602 (0.17%) 
BACTERAEMIA † 1  0/600 (0.00%)  1/602 (0.17%) 
CATHETER RELATED INFECTION † 1  8/600 (1.33%)  1/602 (0.17%) 
CATHETER SEPSIS † 1  3/600 (0.50%)  0/602 (0.00%) 
CATHETER SITE INFECTION † 1  0/600 (0.00%)  1/602 (0.17%) 
CELLULITIS † 1  3/600 (0.50%)  0/602 (0.00%) 
CENTRAL LINE INFECTION † 1  10/600 (1.67%)  4/602 (0.66%) 
ERYSIPELAS † 1  1/600 (0.17%)  1/602 (0.17%) 
ESCHERICHIA BACTERAEMIA † 1  1/600 (0.17%)  0/602 (0.00%) 
ESCHERICHIA SEPSIS † 1  1/600 (0.17%)  0/602 (0.00%) 
GASTROENTERITIS † 1  1/600 (0.17%)  0/602 (0.00%) 
HERPES ZOSTER † 1  0/600 (0.00%)  1/602 (0.17%) 
INFECTION † 1  4/600 (0.67%)  1/602 (0.17%) 
LISTERIOSIS † 1  0/600 (0.00%)  1/602 (0.17%) 
LOWER RESPIRATORY TRACT INFECTION † 1  2/600 (0.33%)  3/602 (0.50%) 
LUNG ABSCESS † 1  0/600 (0.00%)  1/602 (0.17%) 
NEUTROPENIC INFECTION † 1  1/600 (0.17%)  0/602 (0.00%) 
NEUTROPENIC SEPSIS † 1  1/600 (0.17%)  2/602 (0.33%) 
OTITIS MEDIA CHRONIC † 1  1/600 (0.17%)  0/602 (0.00%) 
PELVIC ABSCESS † 1  0/600 (0.00%)  1/602 (0.17%) 
PERIANAL ABSCESS † 1  1/600 (0.17%)  0/602 (0.00%) 
PNEUMONIA † 1  9/600 (1.50%)  7/602 (1.16%) 
PNEUMONIA KLEBSIELLA † 1  1/600 (0.17%)  0/602 (0.00%) 
PNEUMONIA STREPTOCOCCAL † 1  1/600 (0.17%)  0/602 (0.00%) 
POSTOPERATIVE INFECTION † 1  1/600 (0.17%)  0/602 (0.00%) 
POSTOPERATIVE WOUND INFECTION † 1  2/600 (0.33%)  0/602 (0.00%) 
PYELONEPHRITIS † 1  1/600 (0.17%)  1/602 (0.17%) 
PYELONEPHRITIS ACUTE † 1  0/600 (0.00%)  1/602 (0.17%) 
RESPIRATORY TRACT INFECTION † 1  0/600 (0.00%)  1/602 (0.17%) 
RETROPERITONEAL ABSCESS † 1  1/600 (0.17%)  0/602 (0.00%) 
SEPSIS † 1  4/600 (0.67%)  1/602 (0.17%) 
SEPTIC SHOCK † 1  3/600 (0.50%)  0/602 (0.00%) 
SINUSITIS † 1  1/600 (0.17%)  0/602 (0.00%) 
SKIN INFECTION † 1  0/600 (0.00%)  1/602 (0.17%) 
STAPHYLOCOCCAL INFECTION † 1  0/600 (0.00%)  1/602 (0.17%) 
STAPHYLOCOCCAL SEPSIS † 1  1/600 (0.17%)  0/602 (0.00%) 
STREPTOCOCCAL SEPSIS † 1  1/600 (0.17%)  0/602 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION † 1  3/600 (0.50%)  0/602 (0.00%) 
URINARY TRACT INFECTION † 1  4/600 (0.67%)  3/602 (0.50%) 
VARICELLA † 1  0/600 (0.00%)  1/602 (0.17%) 
WOUND INFECTION † 1  1/600 (0.17%)  0/602 (0.00%) 
ACUTE GASTROENTERITIS † 1 [1]  0/600 (0.00%)  1/602 (0.17%) 
ACUTE PNEUMONIA † 1 [1]  1/600 (0.17%)  0/602 (0.00%) 
INFECTION OF OSTEOSYNTHESIS IN RIGHT ANCLE † 1 [1]  1/600 (0.17%)  0/602 (0.00%) 
Injury, poisoning and procedural complications     
ALCOHOL POISONING † 1  1/600 (0.17%)  0/602 (0.00%) 
ANASTOMOTIC STENOSIS † 1  0/600 (0.00%)  1/602 (0.17%) 
FALL † 1  1/600 (0.17%)  1/602 (0.17%) 
FEMORAL NECK FRACTURE † 1  1/600 (0.17%)  0/602 (0.00%) 
FEMUR FRACTURE † 1  1/600 (0.17%)  0/602 (0.00%) 
FIBULA FRACTURE † 1  1/600 (0.17%)  0/602 (0.00%) 
FRACTURED SACRUM † 1  0/600 (0.00%)  1/602 (0.17%) 
HIP FRACTURE † 1  3/600 (0.50%)  1/602 (0.17%) 
INTESTINAL STOMA COMPLICATION † 1  0/600 (0.00%)  2/602 (0.33%) 
LIMB INJURY † 1  1/600 (0.17%)  1/602 (0.17%) 
OVERDOSE † 1  1/600 (0.17%)  0/602 (0.00%) 
PATELLA FRACTURE † 1  0/600 (0.00%)  1/602 (0.17%) 
POST PROCEDURAL BILE LEAK † 1  1/600 (0.17%)  0/602 (0.00%) 
SPINAL COMPRESSION FRACTURE † 1  0/600 (0.00%)  1/602 (0.17%) 
STENT OCCLUSION † 1  0/600 (0.00%)  1/602 (0.17%) 
SUBDURAL HAEMATOMA † 1  1/600 (0.17%)  0/602 (0.00%) 
VASCULAR ACCESS COMPLICATION † 1  0/600 (0.00%)  1/602 (0.17%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED † 1  0/600 (0.00%)  1/602 (0.17%) 
BLOOD CREATININE INCREASED † 1  2/600 (0.33%)  0/602 (0.00%) 
C-REACTIVE PROTEIN INCREASED † 1  0/600 (0.00%)  1/602 (0.17%) 
HAEMOGLOBIN DECREASED † 1  0/600 (0.00%)  1/602 (0.17%) 
HEPATIC ENZYME INCREASED † 1  0/600 (0.00%)  1/602 (0.17%) 
LABORATORY TEST ABNORMAL † 1  1/600 (0.17%)  0/602 (0.00%) 
NEUTROPHIL COUNT DECREASED † 1  1/600 (0.17%)  1/602 (0.17%) 
PLATELET COUNT DECREASED † 1  1/600 (0.17%)  0/602 (0.00%) 
URINE ANALYSIS ABNORMAL † 1  0/600 (0.00%)  1/602 (0.17%) 
WEIGHT DECREASED † 1  1/600 (0.17%)  0/602 (0.00%) 
WHITE BLOOD CELL COUNT DECREASED † 1  1/600 (0.17%)  1/602 (0.17%) 
Metabolism and nutrition disorders     
ANOREXIA † 1  4/600 (0.67%)  4/602 (0.66%) 
CACHEXIA † 1  1/600 (0.17%)  1/602 (0.17%) 
DEHYDRATION † 1  16/600 (2.67%)  12/602 (1.99%) 
DIABETES MELLITUS † 1  0/600 (0.00%)  1/602 (0.17%) 
DIABETIC KETOACIDOSIS † 1  1/600 (0.17%)  0/602 (0.00%) 
ELECTROLYTE IMBALANCE † 1  1/600 (0.17%)  0/602 (0.00%) 
HYPERGLYCAEMIA † 1  3/600 (0.50%)  0/602 (0.00%) 
HYPERKALAEMIA † 1  1/600 (0.17%)  0/602 (0.00%) 
HYPOALBUMINAEMIA † 1  1/600 (0.17%)  0/602 (0.00%) 
HYPOCALCAEMIA † 1  3/600 (0.50%)  0/602 (0.00%) 
HYPOGLYCAEMIA † 1  0/600 (0.00%)  1/602 (0.17%) 
HYPOKALAEMIA † 1  4/600 (0.67%)  2/602 (0.33%) 
HYPOMAGNESAEMIA † 1  13/600 (2.17%)  1/602 (0.17%) 
HYPONATRAEMIA † 1  0/600 (0.00%)  1/602 (0.17%) 
LACTIC ACIDOSIS † 1  1/600 (0.17%)  0/602 (0.00%) 
MALNUTRITION † 1  0/600 (0.00%)  1/602 (0.17%) 
METABOLIC ACIDOSIS † 1  2/600 (0.33%)  0/602 (0.00%) 
ORAL INTAKE REDUCED † 1  2/600 (0.33%)  0/602 (0.00%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN † 1  2/600 (0.33%)  2/602 (0.33%) 
JOINT SWELLING † 1  1/600 (0.17%)  0/602 (0.00%) 
MYALGIA † 1  0/600 (0.00%)  1/602 (0.17%) 
PAIN IN EXTREMITY † 1  0/600 (0.00%)  2/602 (0.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BLADDER NEOPLASM † 1  1/600 (0.17%)  0/602 (0.00%) 
CANCER PAIN † 1  0/600 (0.00%)  1/602 (0.17%) 
MALIGNANT NEOPLASM PROGRESSION † 1  2/600 (0.33%)  0/602 (0.00%) 
METASTASES TO CENTRAL NERVOUS SYSTEM † 1  2/600 (0.33%)  0/602 (0.00%) 
OVARIAN LOW MALIGNANT POTENTIAL TUMOUR † 1  1/600 (0.17%)  0/602 (0.00%) 
TUMOUR ASSOCIATED FEVER † 1  1/600 (0.17%)  0/602 (0.00%) 
TUMOUR HAEMORRHAGE † 1  1/600 (0.17%)  0/602 (0.00%) 
Nervous system disorders     
CEREBRAL HAEMORRHAGE † 1  1/600 (0.17%)  0/602 (0.00%) 
CEREBRAL ISCHAEMIA † 1  2/600 (0.33%)  0/602 (0.00%) 
CEREBROVASCULAR ACCIDENT † 1  0/600 (0.00%)  1/602 (0.17%) 
COMA † 1  0/600 (0.00%)  1/602 (0.17%) 
CONVULSION † 1  1/600 (0.17%)  0/602 (0.00%) 
COORDINATION ABNORMAL † 1  0/600 (0.00%)  1/602 (0.17%) 
DEPRESSED LEVEL OF CONSCIOUSNESS † 1  0/600 (0.00%)  1/602 (0.17%) 
DIZZINESS † 1  2/600 (0.33%)  0/602 (0.00%) 
EPILEPSY † 1  1/600 (0.17%)  1/602 (0.17%) 
HEADACHE † 1  1/600 (0.17%)  0/602 (0.00%) 
HEMIPARESIS † 1  2/600 (0.33%)  0/602 (0.00%) 
LETHARGY † 1  0/600 (0.00%)  1/602 (0.17%) 
LOSS OF CONSCIOUSNESS † 1  2/600 (0.33%)  0/602 (0.00%) 
PARAESTHESIA † 1  0/600 (0.00%)  1/602 (0.17%) 
SOMNOLENCE † 1  1/600 (0.17%)  0/602 (0.00%) 
SPINAL CORD COMPRESSION † 1  1/600 (0.17%)  0/602 (0.00%) 
SYNCOPE † 1  2/600 (0.33%)  2/602 (0.33%) 
TRANSIENT ISCHAEMIC ATTACK † 1  0/600 (0.00%)  1/602 (0.17%) 
VOCAL CORD PARALYSIS † 1  0/600 (0.00%)  1/602 (0.17%) 
Psychiatric disorders     
ABNORMAL BEHAVIOUR † 1  0/600 (0.00%)  1/602 (0.17%) 
CONFUSIONAL STATE † 1  1/600 (0.17%)  2/602 (0.33%) 
EUPHORIC MOOD † 1  1/600 (0.17%)  0/602 (0.00%) 
MENTAL STATUS CHANGES † 1  1/600 (0.17%)  0/602 (0.00%) 
Renal and urinary disorders     
CALCULUS URETERIC † 1  2/600 (0.33%)  0/602 (0.00%) 
CALCULUS URINARY † 1  1/600 (0.17%)  0/602 (0.00%) 
DYSURIA † 1  1/600 (0.17%)  1/602 (0.17%) 
HAEMATURIA † 1  0/600 (0.00%)  1/602 (0.17%) 
HAEMORRHAGE URINARY TRACT † 1  1/600 (0.17%)  0/602 (0.00%) 
HYDRONEPHROSIS † 1  1/600 (0.17%)  1/602 (0.17%) 
NEPHROLITHIASIS † 1  0/600 (0.00%)  1/602 (0.17%) 
RENAL COLIC † 1  0/600 (0.00%)  1/602 (0.17%) 
RENAL FAILURE † 1  2/600 (0.33%)  1/602 (0.17%) 
RENAL FAILURE ACUTE † 1  1/600 (0.17%)  1/602 (0.17%) 
URETERIC OBSTRUCTION † 1  2/600 (0.33%)  1/602 (0.17%) 
URINARY RETENTION † 1  1/600 (0.17%)  1/602 (0.17%) 
VAGINAL HAEMORRHAGE † 1  1/600 (0.17%)  0/602 (0.00%) 
Reproductive system and breast disorders     
BENIGN PROSTATIC HYPERPLASIA † 1  0/600 (0.00%)  1/602 (0.17%) 
Respiratory, thoracic and mediastinal disorders     
ASTHMA † 1  1/600 (0.17%)  0/602 (0.00%) 
BRONCHOSPASM † 1  0/600 (0.00%)  1/602 (0.17%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE † 1  0/600 (0.00%)  1/602 (0.17%) 
DYSPNOEA † 1  7/600 (1.17%)  4/602 (0.66%) 
PLEURAL EFFUSION † 1  3/600 (0.50%)  0/602 (0.00%) 
PLEURITIC PAIN † 1  2/600 (0.33%)  0/602 (0.00%) 
PULMONARY EMBOLISM † 1  20/600 (3.33%)  10/602 (1.66%) 
PULMONARY OEDEMA † 1  1/600 (0.17%)  0/602 (0.00%) 
RESPIRATORY FAILURE † 1  2/600 (0.33%)  1/602 (0.17%) 
Skin and subcutaneous tissue disorders     
ACNE † 1  2/600 (0.33%)  0/602 (0.00%) 
DERMATITIS ACNEIFORM † 1  1/600 (0.17%)  0/602 (0.00%) 
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME † 1  1/600 (0.17%)  1/602 (0.17%) 
RASH † 1  1/600 (0.17%)  0/602 (0.00%) 
Surgical and medical procedures     
CATARACT OPERATION † 1  1/600 (0.17%)  0/602 (0.00%) 
Vascular disorders     
AXILLARY VEIN THROMBOSIS † 1  1/600 (0.17%)  0/602 (0.00%) 
CIRCULATORY COLLAPSE † 1  1/600 (0.17%)  0/602 (0.00%) 
DEEP VEIN THROMBOSIS † 1  9/600 (1.50%)  5/602 (0.83%) 
EMBOLISM † 1  0/600 (0.00%)  1/602 (0.17%) 
HYPERTENSION † 1  1/600 (0.17%)  0/602 (0.00%) 
HYPOTENSION † 1  5/600 (0.83%)  3/602 (0.50%) 
INTERMITTENT CLAUDICATION † 1  0/600 (0.00%)  1/602 (0.17%) 
ISCHAEMIA † 1  0/600 (0.00%)  1/602 (0.17%) 
JUGULAR VEIN THROMBOSIS † 1  1/600 (0.17%)  0/602 (0.00%) 
PERIPHERAL ISCHAEMIA † 1  0/600 (0.00%)  1/602 (0.17%) 
PERIPHERAL OCCLUSIVE DISEASE † 1  1/600 (0.17%)  0/602 (0.00%) 
PHLEBITIS † 1  0/600 (0.00%)  1/602 (0.17%) 
SUBCLAVIAN VEIN THROMBOSIS † 1  0/600 (0.00%)  1/602 (0.17%) 
THROMBOSIS † 1  4/600 (0.67%)  4/602 (0.66%) 
VENA CAVA THROMBOSIS † 1  1/600 (0.17%)  0/602 (0.00%) 
VENOUS THROMBOSIS † 1  2/600 (0.33%)  1/602 (0.17%) 
VENOUS THROMBOSIS LIMB † 1  1/600 (0.17%)  0/602 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
[1]
An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cetuximab Plus FOLFIRI FOLFIRI Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   593/600 (98.83%)   591/602 (98.17%) 
Blood and lymphatic system disorders     
NEUTROPENIA † 1  272/600 (45.33%)  249/602 (41.36%) 
LEUKOPENIA † 1  127/600 (21.17%)  120/602 (19.93%) 
ANAEMIA † 1  121/600 (20.17%)  127/602 (21.10%) 
THROMBOCYTOPENIA † 1  31/600 (5.17%)  20/602 (3.32%) 
LYMPHOPENIA † 1  29/600 (4.83%)  35/602 (5.81%) 
Eye disorders     
CONJUNCTIVITIS † 1  88/600 (14.67%)  13/602 (2.16%) 
Gastrointestinal disorders     
DIARRHOEA † 1  377/600 (62.83%)  353/602 (58.64%) 
NAUSEA † 1  322/600 (53.67%)  359/602 (59.63%) 
VOMITING † 1  194/600 (32.33%)  231/602 (38.37%) 
STOMATITIS † 1  169/600 (28.17%)  110/602 (18.27%) 
ABDOMINAL PAIN † 1  142/600 (23.67%)  154/602 (25.58%) 
CONSTIPATION † 1  135/600 (22.50%)  119/602 (19.77%) 
DYSPEPSIA † 1  78/600 (13.00%)  46/602 (7.64%) 
ABDOMINAL PAIN UPPER † 1  45/600 (7.50%)  33/602 (5.48%) 
General disorders     
FATIGUE † 1  192/600 (32.00%)  186/602 (30.90%) 
PYREXIA † 1  136/600 (22.67%)  64/602 (10.63%) 
ASTHENIA † 1  110/600 (18.33%)  112/602 (18.60%) 
MUCOSAL INFLAMMATION † 1  82/600 (13.67%)  53/602 (8.80%) 
OEDEMA PERIPHERAL † 1  48/600 (8.00%)  42/602 (6.98%) 
INJECTION SITE REACTION † 1  40/600 (6.67%)  38/602 (6.31%) 
Infections and infestations     
PARONYCHIA † 1  107/600 (17.83%)  3/602 (0.50%) 
NASOPHARYNGITIS † 1  30/600 (5.00%)  35/602 (5.81%) 
Investigations     
WEIGHT DECREASED † 1  94/600 (15.67%)  52/602 (8.64%) 
Metabolism and nutrition disorders     
ANOREXIA † 1  169/600 (28.17%)  149/602 (24.75%) 
HYPOKALAEMIA † 1  58/600 (9.67%)  30/602 (4.98%) 
HYPOMAGNESAEMIA † 1  42/600 (7.00%)  3/602 (0.50%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN † 1  38/600 (6.33%)  55/602 (9.14%) 
PAIN IN EXTREMITY † 1  30/600 (5.00%)  23/602 (3.82%) 
Nervous system disorders     
HEADACHE † 1  64/600 (10.67%)  55/602 (9.14%) 
DIZZINESS † 1  43/600 (7.17%)  40/602 (6.64%) 
DYSGEUSIA † 1  41/600 (6.83%)  45/602 (7.48%) 
Psychiatric disorders     
INSOMNIA † 1  57/600 (9.50%)  53/602 (8.80%) 
Respiratory, thoracic and mediastinal disorders     
COUGH † 1  64/600 (10.67%)  59/602 (9.80%) 
DYSPNOEA † 1  53/600 (8.83%)  32/602 (5.32%) 
EPISTAXIS † 1  50/600 (8.33%)  27/602 (4.49%) 
Skin and subcutaneous tissue disorders     
RASH † 1  270/600 (45.00%)  23/602 (3.82%) 
ALOPECIA † 1  224/600 (37.33%)  229/602 (38.04%) 
DERMATITIS ACNEIFORM † 1  146/600 (24.33%)  2/602 (0.33%) 
DRY SKIN † 1  133/600 (22.17%)  30/602 (4.98%) 
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME † 1  101/600 (16.83%)  27/602 (4.49%) 
SKIN FISSURES † 1  97/600 (16.17%)  10/602 (1.66%) 
PRURITUS † 1  73/600 (12.17%)  28/602 (4.65%) 
ACNE † 1  69/600 (11.50%)  1/602 (0.17%) 
NAIL DISORDER † 1  54/600 (9.00%)  5/602 (0.83%) 
ERYTHEMA † 1  40/600 (6.67%)  12/602 (1.99%) 
EXFOLIATIVE RASH † 1  35/600 (5.83%)  3/602 (0.50%) 
SKIN TOXICITY † 1  34/600 (5.67%)  1/602 (0.17%) 
Vascular disorders     
HYPERTENSION † 1  46/600 (7.67%)  36/602 (5.98%) 
PHLEBITIS † 1  38/600 (6.33%)  20/602 (3.32%) 
HYPOTENSION † 1  32/600 (5.33%)  20/602 (3.32%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
A non-specific outcome measure 'Safety' was deleted from the entry in error. A replacement outcome was created. The outcome refers to adverse events.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Monika Foerster/Clinical Trial Leader
Organization: Merck Serono
Phone: +496151729517
EMail: monika.foerster@merck.de
Publications of Results:
Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.
Van Cutsem E, Lang I, Folprecht G, Nowacki M, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Celik I, Kohne C Cetuximab plus FOLFIRI in the treatment of metastatic colorectal cancer (mCRC): The influence of KRAS and BRAF biomarkers on outcome: Updated data from the CRYSTAL trial. ASCO 2010 Gastrointestinal Cancers Symposium, Orlando, USA January 2010 Abstract No: 281
Lang I, Kohne CH, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Zubel A, Van Cutsem E Cetuximab plus FOLFIRI in 1st-line treatment of metastatic colorectal cancer: Quality of life (QoL) analysis of patients (pts) with KRAS wild-type (wt) tumours in the CRYSTAL trial. European Journal of Cancer Supplements. 2009 7(2):345
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Monika Foerster, Merck Serono
ClinicalTrials.gov Identifier: NCT00154102    
Other Study ID Numbers: EMR 62202-013
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: November 30, 2010
Results First Posted: February 23, 2011
Last Update Posted: January 30, 2017