Clinical trial

Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic…

NCT00154102 · Merck KGaA, Darmstadt, Germany, Industry · Completed

Key facts

NCT number NCT00154102
Title Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (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
Acronym CRYSTAL
Lead sponsor Merck KGaA, Darmstadt, Germany, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer
Intervention type Drug
Interventions Cetuximab, FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
Enrollment 1,221
Start date May 1, 2004
Primary completion Dec 1, 2006
Completion Mar 1, 2011
First posted Sep 12, 2005
Last update posted Jan 30, 2017
Countries Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Czechia, Finland, France, Germany, Greece and 18 more

At a glance

  • 100–999 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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