Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
NCT ID: NCT00154102
Last Updated: 2017-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1221 participants
INTERVENTIONAL
2004-05-31
2011-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cetuximab Plus FOLFIRI
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
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
FOLFIRI Alone
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Merck Serono
Principal Investigators
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Eric van Cutsem, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital Gasthuisberg, Department Internal Medicine, Leuven, Belgium
Locations
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Research Site
Buenos Aires, , Argentina
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Bedford Park, , Australia
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Darlinghurst, , Australia
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Heidelberg, , Australia
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Nedlands, , Australia
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West Perth, , Australia
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Woodville, , Australia
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Innsbruck, , Austria
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Klagenfurt, , Austria
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Kufstein, , Austria
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Salzburg, , Austria
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Sankt Pölten, , Austria
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Sankt Veit an der Glan, , Austria
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Vienna, , Austria
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Wels, , Austria
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Antwerp, , Belgium
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Bonheiden, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Goiânia, , Brazil
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Porto Alegre, , Brazil
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Santo André, , Brazil
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São Paulo, , Brazil
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Pleven, , Bulgaria
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Plovidiv, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Santiago-Las Condes, , Chile
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Santiago-Providencia, , Chile
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Chomutov, , Czechia
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Prague, , Czechia
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Turku, , Finland
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Bordeaux, , France
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Boulogne-Billancourt, , France
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Colmar, , France
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Grenoble, , France
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La Roche-sur-Yon, , France
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Lorient, , France
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Marseille, , France
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Nantes, , France
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Périgueux, , France
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Rennes, , France
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Saint-Grégoire, , France
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Strasbourg, , France
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Toulon, , France
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Villejuif, , France
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Dortmund, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Essen, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Göttingen, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Homburg/Saar, , Germany
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Jena, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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München, , Germany
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Oldenburg, , Germany
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Ulm, , Germany
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Alexandroupoli, , Greece
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Athens, , Greece
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Heraklion, , Greece
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Pokfulam, , Hong Kong
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Shatin, , Hong Kong
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Kecskemét, , Hungary
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Pécs, , Hungary
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Ancona, , Italy
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Aviano, , Italy
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Bari, , Italy
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Benevento, , Italy
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Florence, , Italy
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Mantova, , Italy
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Milan, , Italy
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Modena, , Italy
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Napoli, , Italy
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Reggio Emilia, , Italy
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Roma, , Italy
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Rozzano, , Italy
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México, , Mexico
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Amsterdam, , Netherlands
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Apeldoom, , Netherlands
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Blaricum, , Netherlands
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Roosendaal, , Netherlands
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The Hague, , Netherlands
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Zwolle, , Netherlands
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Bialystok, , Poland
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Gliwice, , Poland
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Krakow, , Poland
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Opole, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Cluj-Napoca, , Romania
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Iași, , Romania
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Suceava, , Romania
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Moscow, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Singapore, , Singapore
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Trnava, , Slovakia
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Žilina, , Slovakia
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Cape Town, , South Africa
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Durban, , South Africa
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Johannesburg, , South Africa
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Port Elizabeth, , South Africa
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Pretoria, , South Africa
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Seoul, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Cadiz, , Spain
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Madrid, , Spain
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Palma de Mallorca, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
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Stockholm, , Sweden
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Changhua, , Taiwan
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Chiayi City, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Charkassy, , Ukraine
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kiev, , Ukraine
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Kryvyi Rih, , Ukraine
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Luhansk, , Ukraine
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Lviv, , Ukraine
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Uzhhorod, , Ukraine
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Zhaporozhye, , Ukraine
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Brighton, , United Kingdom
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Cambridge, , United Kingdom
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Glasgow, , United Kingdom
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Guildford, , United Kingdom
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Kent, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Peterborough, , United Kingdom
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Rhyl, , United Kingdom
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Sutton, , United Kingdom
Countries
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References
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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
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.
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.
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.
Other Identifiers
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EMR 62202-013
Identifier Type: -
Identifier Source: org_study_id
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