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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00154102




Registration number
NCT00154102
Ethics application status
Date submitted
8/09/2005
Date registered
12/09/2005
Date last updated
30/01/2017

Titles & IDs
Public title
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
Scientific 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
Secondary ID [1] 0 0
EMR 62202-013
Universal Trial Number (UTN)
Trial acronym
CRYSTAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cetuximab
Treatment: Drugs - FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)

Experimental: Cetuximab Plus FOLFIRI -

Active comparator: FOLFIRI Alone -


Treatment: Drugs: Cetuximab
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

Treatment: Drugs: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments
Timepoint [2] 0 0
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
Primary outcome [3] 0 0
Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
Timepoint [3] 0 0
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 [1] 0 0
Overall Survival Time (OS)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Overall Survival Time (KRAS Wild-Type Population)
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Overall Survival Time (KRAS Mutant Population)
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Best Overall Response Rate - Independent Review Committee (IRC) Assessments
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Disease Control Rate - Independent Review Committee (IRC) Assessments
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Duration of Response - Independent Review Committee (IRC) Assessments
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Participants With No Residual Tumor After Metastatic Surgery
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
Safety - Number of Patients Experiencing Any Adverse Event
Timepoint [12] 0 0
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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
1221
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Darlinghurst
Recruitment hospital [3] 0 0
Research Site - Heidelberg
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment hospital [5] 0 0
Research Site - West Perth
Recruitment hospital [6] 0 0
Research Site - Woodville
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment postcode(s) [5] 0 0
- West Perth
Recruitment postcode(s) [6] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Klagenfurt
Country [4] 0 0
Austria
State/province [4] 0 0
Kufstein
Country [5] 0 0
Austria
State/province [5] 0 0
Salzburg
Country [6] 0 0
Austria
State/province [6] 0 0
St. Pölten
Country [7] 0 0
Austria
State/province [7] 0 0
St. Veit an der Glan
Country [8] 0 0
Austria
State/province [8] 0 0
Wels
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerpen
Country [11] 0 0
Belgium
State/province [11] 0 0
Bonheiden
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Edegem
Country [14] 0 0
Belgium
State/province [14] 0 0
Gent
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Belgium
State/province [16] 0 0
Liège
Country [17] 0 0
Brazil
State/province [17] 0 0
Goiania
Country [18] 0 0
Brazil
State/province [18] 0 0
Porto Alegre
Country [19] 0 0
Brazil
State/province [19] 0 0
Santo André
Country [20] 0 0
Brazil
State/province [20] 0 0
Sao Paulo
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Pleven
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Plovidiv
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sofia
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Varna
Country [25] 0 0
Chile
State/province [25] 0 0
Santiago-Las Condes
Country [26] 0 0
Chile
State/province [26] 0 0
Santiago-Providencia
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Chomutov
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Prague
Country [29] 0 0
Finland
State/province [29] 0 0
Turku
Country [30] 0 0
France
State/province [30] 0 0
Bordeaux
Country [31] 0 0
France
State/province [31] 0 0
Boulogne-Billancourt
Country [32] 0 0
France
State/province [32] 0 0
Colmar
Country [33] 0 0
France
State/province [33] 0 0
Grenoble
Country [34] 0 0
France
State/province [34] 0 0
La Roche sur Yon
Country [35] 0 0
France
State/province [35] 0 0
Lorient
Country [36] 0 0
France
State/province [36] 0 0
Marseille
Country [37] 0 0
France
State/province [37] 0 0
Nantes
Country [38] 0 0
France
State/province [38] 0 0
Perigueux
Country [39] 0 0
France
State/province [39] 0 0
Rennes Cedex
Country [40] 0 0
France
State/province [40] 0 0
Saint Gregoire
Country [41] 0 0
France
State/province [41] 0 0
Strasbourg
Country [42] 0 0
France
State/province [42] 0 0
Toulon
Country [43] 0 0
France
State/province [43] 0 0
Villejuif Cedex
Country [44] 0 0
Germany
State/province [44] 0 0
Dortmund
Country [45] 0 0
Germany
State/province [45] 0 0
Dresden
Country [46] 0 0
Germany
State/province [46] 0 0
Düsseldorf
Country [47] 0 0
Germany
State/province [47] 0 0
Essen
Country [48] 0 0
Germany
State/province [48] 0 0
Frankfurt am Main
Country [49] 0 0
Germany
State/province [49] 0 0
Freiburg
Country [50] 0 0
Germany
State/province [50] 0 0
Göttingen
Country [51] 0 0
Germany
State/province [51] 0 0
Halle
Country [52] 0 0
Germany
State/province [52] 0 0
Hamburg
Country [53] 0 0
Germany
State/province [53] 0 0
Heidelberg
Country [54] 0 0
Germany
State/province [54] 0 0
Homburg/Saar
Country [55] 0 0
Germany
State/province [55] 0 0
Jena
Country [56] 0 0
Germany
State/province [56] 0 0
Mainz
Country [57] 0 0
Germany
State/province [57] 0 0
Mannheim
Country [58] 0 0
Germany
State/province [58] 0 0
München
Country [59] 0 0
Germany
State/province [59] 0 0
Oldenburg
Country [60] 0 0
Germany
State/province [60] 0 0
Ulm
Country [61] 0 0
Greece
State/province [61] 0 0
Alexandroupolis
Country [62] 0 0
Greece
State/province [62] 0 0
Athens
Country [63] 0 0
Greece
State/province [63] 0 0
Heraklion
Country [64] 0 0
Hong Kong
State/province [64] 0 0
Pokfulam
Country [65] 0 0
Hong Kong
State/province [65] 0 0
Shatin
Country [66] 0 0
Hungary
State/province [66] 0 0
Budapest
Country [67] 0 0
Hungary
State/province [67] 0 0
Debrecen
Country [68] 0 0
Hungary
State/province [68] 0 0
Györ
Country [69] 0 0
Hungary
State/province [69] 0 0
Kecskemét
Country [70] 0 0
Hungary
State/province [70] 0 0
Pécs
Country [71] 0 0
Italy
State/province [71] 0 0
Ancona
Country [72] 0 0
Italy
State/province [72] 0 0
Aviano
Country [73] 0 0
Italy
State/province [73] 0 0
Bari
Country [74] 0 0
Italy
State/province [74] 0 0
Benevento
Country [75] 0 0
Italy
State/province [75] 0 0
Firenze
Country [76] 0 0
Italy
State/province [76] 0 0
Mantova
Country [77] 0 0
Italy
State/province [77] 0 0
Milano
Country [78] 0 0
Italy
State/province [78] 0 0
Modena
Country [79] 0 0
Italy
State/province [79] 0 0
Napoli
Country [80] 0 0
Italy
State/province [80] 0 0
Reggio Emilia
Country [81] 0 0
Italy
State/province [81] 0 0
Roma
Country [82] 0 0
Italy
State/province [82] 0 0
Rozzano
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Seoul
Country [84] 0 0
Mexico
State/province [84] 0 0
Mexico
Country [85] 0 0
Netherlands
State/province [85] 0 0
Amsterdam
Country [86] 0 0
Netherlands
State/province [86] 0 0
Apeldoom
Country [87] 0 0
Netherlands
State/province [87] 0 0
Blaricum
Country [88] 0 0
Netherlands
State/province [88] 0 0
Den Haag
Country [89] 0 0
Netherlands
State/province [89] 0 0
Roosendaal
Country [90] 0 0
Netherlands
State/province [90] 0 0
Zwolle
Country [91] 0 0
Poland
State/province [91] 0 0
Bialystok
Country [92] 0 0
Poland
State/province [92] 0 0
Gliwice
Country [93] 0 0
Poland
State/province [93] 0 0
Krakow
Country [94] 0 0
Poland
State/province [94] 0 0
Opole
Country [95] 0 0
Poland
State/province [95] 0 0
Poznan
Country [96] 0 0
Poland
State/province [96] 0 0
Warsaw
Country [97] 0 0
Poland
State/province [97] 0 0
Wroclaw
Country [98] 0 0
Romania
State/province [98] 0 0
Cluj Napoca
Country [99] 0 0
Romania
State/province [99] 0 0
Iasi
Country [100] 0 0
Romania
State/province [100] 0 0
Suceava
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Moscow
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Saint Petersburg
Country [103] 0 0
Russian Federation
State/province [103] 0 0
Yaroslavl
Country [104] 0 0
Singapore
State/province [104] 0 0
Singapore
Country [105] 0 0
Slovakia
State/province [105] 0 0
Banska Bystrica
Country [106] 0 0
Slovakia
State/province [106] 0 0
Bratislava
Country [107] 0 0
Slovakia
State/province [107] 0 0
Kosice
Country [108] 0 0
Slovakia
State/province [108] 0 0
Trnava
Country [109] 0 0
Slovakia
State/province [109] 0 0
Zilina
Country [110] 0 0
South Africa
State/province [110] 0 0
Cape Town
Country [111] 0 0
South Africa
State/province [111] 0 0
Durban
Country [112] 0 0
South Africa
State/province [112] 0 0
Johannesburg
Country [113] 0 0
South Africa
State/province [113] 0 0
Port Elizabeth
Country [114] 0 0
South Africa
State/province [114] 0 0
Pretoria
Country [115] 0 0
Spain
State/province [115] 0 0
A Coruna
Country [116] 0 0
Spain
State/province [116] 0 0
Barcelona
Country [117] 0 0
Spain
State/province [117] 0 0
Cadiz
Country [118] 0 0
Spain
State/province [118] 0 0
Madrid
Country [119] 0 0
Spain
State/province [119] 0 0
Palma de Mallorca
Country [120] 0 0
Spain
State/province [120] 0 0
Valencia
Country [121] 0 0
Sweden
State/province [121] 0 0
Göteborg
Country [122] 0 0
Sweden
State/province [122] 0 0
Stockholm
Country [123] 0 0
Taiwan
State/province [123] 0 0
Changhua
Country [124] 0 0
Taiwan
State/province [124] 0 0
Chiayi
Country [125] 0 0
Taiwan
State/province [125] 0 0
Taipei
Country [126] 0 0
Taiwan
State/province [126] 0 0
Taoyuan
Country [127] 0 0
Turkey
State/province [127] 0 0
Ankara
Country [128] 0 0
Turkey
State/province [128] 0 0
Istanbul
Country [129] 0 0
Turkey
State/province [129] 0 0
Izmir
Country [130] 0 0
Ukraine
State/province [130] 0 0
Charkassy
Country [131] 0 0
Ukraine
State/province [131] 0 0
Donetsk
Country [132] 0 0
Ukraine
State/province [132] 0 0
Ivano-Frankivsk
Country [133] 0 0
Ukraine
State/province [133] 0 0
Kiev
Country [134] 0 0
Ukraine
State/province [134] 0 0
Krivoy Rog
Country [135] 0 0
Ukraine
State/province [135] 0 0
Lugansk
Country [136] 0 0
Ukraine
State/province [136] 0 0
Lviv
Country [137] 0 0
Ukraine
State/province [137] 0 0
Uzhgorod
Country [138] 0 0
Ukraine
State/province [138] 0 0
Zhaporozhye
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Brighton
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Cambridge
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Glasgow
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Guildford
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Kent
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Leicester
Country [145] 0 0
United Kingdom
State/province [145] 0 0
London
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Peterborough
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Rhyl
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck KGaA, Darmstadt, Germany
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eric van Cutsem, Professor
Address 0 0
University Hospital Gasthuisberg, Department Internal Medicine, Leuven, Belgium
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT00154102