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

Primary Purpose

Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cetuximab
FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer focused on measuring Metastatic colorectal cancer, EGFR, Irinotecan, cetuximab, first-line treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum Inoperable metastatic disease Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue Presence of at least 1 bi-dimensionally measurable index lesion Exclusion Criteria: Previous irinotecan-based chemotherapy Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of study treatment Brain metastasis

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cetuximab Plus FOLFIRI

FOLFIRI Alone

Arm Description

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments
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.
Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments
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.
Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
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.

Secondary Outcome Measures

Overall Survival Time (OS)
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.
Overall Survival Time (KRAS Wild-Type Population)
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.
Overall Survival Time (KRAS Mutant Population)
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.
Best Overall Response Rate - Independent Review Committee (IRC) Assessments
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).
Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments
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).
Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
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).
Disease Control Rate - Independent Review Committee (IRC) Assessments
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).
Duration of Response - Independent Review Committee (IRC) Assessments
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.
Participants With No Residual Tumor After Metastatic Surgery
Participants with no residual tumor after on-study surgery for metastases
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
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.
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
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.
Safety - Number of Patients Experiencing Any Adverse Event
Please refer to Adverse Events section for further details

Full Information

First Posted
September 8, 2005
Last Updated
January 12, 2017
Sponsor
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00154102
Brief Title
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
Acronym
CRYSTAL
Official Title
Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Merck KGaA, Darmstadt, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil (5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the epidermal growth factor (EGF) receptor. Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab (open-label study) and will then be treated until progression of the disease or unacceptable toxicity occur. Regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study together with regular safety assessments (e.g. safety labs). An independent Safety Board of experts will also monitor safety data. After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator. The entire study (from the first patient entering the study to the last collect of follow-up information) is 4-5 years long.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer
Keywords
Metastatic colorectal cancer, EGFR, Irinotecan, cetuximab, first-line treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab Plus FOLFIRI
Arm Type
Experimental
Arm Title
FOLFIRI Alone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Number of Cycles: until progression or unacceptable toxicity develops
Intervention Type
Drug
Intervention Name(s)
FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
Intervention 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
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments
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
Title
Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments
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
Title
Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
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
Secondary Outcome Measure Information:
Title
Overall Survival Time (OS)
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
Title
Overall Survival Time (KRAS Wild-Type Population)
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
Title
Overall Survival Time (KRAS Mutant Population)
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
Title
Best Overall Response Rate - Independent Review Committee (IRC) Assessments
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
Title
Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments
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
Title
Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
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
Title
Disease Control Rate - Independent Review Committee (IRC) Assessments
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
Title
Duration of Response - Independent Review Committee (IRC) Assessments
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
Title
Participants With No Residual Tumor After Metastatic Surgery
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
Title
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
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
Title
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
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
Title
Safety - Number of Patients Experiencing Any Adverse Event
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum Inoperable metastatic disease Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue Presence of at least 1 bi-dimensionally measurable index lesion Exclusion Criteria: Previous irinotecan-based chemotherapy Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of study treatment Brain metastasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric van Cutsem, Professor
Organizational Affiliation
University Hospital Gasthuisberg, Department Internal Medicine, Leuven, Belgium
Official's Role
Principal Investigator
Facility Information:
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Buenos Aires
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Argentina
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Bedford Park
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Australia
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Darlinghurst
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Australia
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Heidelberg
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Australia
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Nedlands
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Australia
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West Perth
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Australia
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Woodville
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Australia
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Innsbruck
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Austria
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Klagenfurt
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Austria
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Kufstein
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Austria
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Salzburg
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Austria
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St. Pölten
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Austria
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St. Veit an der Glan
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Austria
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Wels
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Austria
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Wien
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Austria
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Antwerpen
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Belgium
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Bonheiden
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Belgium
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Bruxelles
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Liège
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Belgium
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Goiania
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Brazil
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Porto Alegre
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Brazil
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Santo André
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Brazil
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Sao Paulo
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Brazil
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Pleven
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Bulgaria
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Plovidiv
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Bulgaria
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Santiago-Las Condes
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Chile
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Santiago-Providencia
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Chile
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Chomutov
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Czech Republic
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Prague
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Czech Republic
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Turku
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Finland
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Bordeaux
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France
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Boulogne-Billancourt
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France
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Colmar
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France
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Grenoble
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France
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La Roche sur Yon
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France
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Lorient
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France
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Marseille
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France
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Nantes
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France
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Perigueux
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France
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Rennes Cedex
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France
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Saint Gregoire
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France
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Strasbourg
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France
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Toulon
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France
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Villejuif Cedex
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France
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Dortmund
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Germany
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Dresden
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Germany
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Düsseldorf
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Germany
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Essen
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Germany
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Frankfurt am Main
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Germany
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Freiburg
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Germany
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Göttingen
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Germany
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Halle
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Homburg/Saar
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Germany
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Jena
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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München
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Germany
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Oldenburg
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Germany
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Ulm
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Germany
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Alexandroupolis
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Pokfulam
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Hong Kong
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Shatin
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Hong Kong
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Budapest
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Hungary
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Debrecen
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Hungary
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Györ
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Hungary
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Kecskemét
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Hungary
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Pécs
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Hungary
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Ancona
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Italy
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Aviano
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Italy
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Bari
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Italy
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Benevento
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Italy
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Firenze
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Italy
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Mantova
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Italy
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Milano
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Italy
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Modena
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Italy
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Napoli
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Rozzano
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Italy
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Seoul
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Korea, Republic of
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Mexico
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Mexico
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Amsterdam
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Netherlands
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Apeldoom
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Netherlands
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Blaricum
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Netherlands
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Den Haag
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Netherlands
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Roosendaal
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Netherlands
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Zwolle
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Netherlands
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Bialystok
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Poland
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Gliwice
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Poland
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Krakow
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Poland
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Opole
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Poland
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Poznan
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Poland
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Warsaw
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Poland
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Wroclaw
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Poland
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Cluj Napoca
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Romania
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Iasi
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Romania
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Suceava
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Romania
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Yaroslavl
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Russian Federation
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Singapore
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Singapore
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Trnava
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Slovakia
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Zilina
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Slovakia
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Cape Town
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South Africa
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Durban
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South Africa
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Johannesburg
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South Africa
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Port Elizabeth
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South Africa
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Pretoria
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South Africa
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A Coruna
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Spain
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Barcelona
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Spain
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Cadiz
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Spain
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Madrid
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Spain
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Palma de Mallorca
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Spain
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Valencia
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Spain
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Göteborg
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Changhua
Country
Taiwan
Facility Name
Research Site
City
Chiayi
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Taoyuan
Country
Taiwan
Facility Name
Research Site
City
Ankara
Country
Turkey
Facility Name
Research Site
City
Istanbul
Country
Turkey
Facility Name
Research Site
City
Izmir
Country
Turkey
Facility Name
Research Site
City
Charkassy
Country
Ukraine
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Research Site
City
Kiev
Country
Ukraine
Facility Name
Research Site
City
Krivoy Rog
Country
Ukraine
Facility Name
Research Site
City
Lugansk
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
Country
Ukraine
Facility Name
Research Site
City
Zhaporozhye
Country
Ukraine
Facility Name
Research Site
City
Brighton
Country
United Kingdom
Facility Name
Research Site
City
Cambridge
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Guildford
Country
United Kingdom
Facility Name
Research Site
City
Kent
Country
United Kingdom
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Peterborough
Country
United Kingdom
Facility Name
Research Site
City
Rhyl
Country
United Kingdom
Facility Name
Research Site
City
Sutton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19339720
Citation
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.
Results Reference
result
Citation
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
Results Reference
result
Citation
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
Results Reference
result
PubMed Identifier
30657405
Citation
Dercle L, Lu L, Lichtenstein P, Yang H, Wang D, Zhu J, Wu F, Piessevaux H, Schwartz LH, Zhao B. Impact of Variability in Portal Venous Phase Acquisition Timing in Tumor Density Measurement and Treatment Response Assessment: Metastatic Colorectal Cancer as a Paradigm. JCO Clin Cancer Inform. 2017 Nov;1:1-8. doi: 10.1200/CCI.17.00108.
Results Reference
derived
PubMed Identifier
27722750
Citation
Tejpar S, Stintzing S, Ciardiello F, Tabernero J, Van Cutsem E, Beier F, Esser R, Lenz HJ, Heinemann V. Prognostic and Predictive Relevance of Primary Tumor Location in Patients With RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses of the CRYSTAL and FIRE-3 Trials. JAMA Oncol. 2017 Feb 1;3(2):194-201. doi: 10.1001/jamaoncol.2016.3797. Erratum In: JAMA Oncol. 2017 Dec 1;3(12):1742.
Results Reference
derived
PubMed Identifier
23265711
Citation
Licitra L, Storkel S, Kerr KM, Van Cutsem E, Pirker R, Hirsch FR, Vermorken JB, von Heydebreck A, Esser R, Celik I, Ciardiello F. Predictive value of epidermal growth factor receptor expression for first-line chemotherapy plus cetuximab in patients with head and neck and colorectal cancer: analysis of data from the EXTREME and CRYSTAL studies. Eur J Cancer. 2013 Apr;49(6):1161-8. doi: 10.1016/j.ejca.2012.11.018. Epub 2012 Dec 19.
Results Reference
derived

Learn more about this trial

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

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