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Open, randomized, controlled, multicenter phase III study comparing 5FU/ FA [fluorouracil + folinic acid] plus irinotecan (FOLFIRI) plus cetuximab [Erbitux; Merck] versus 5FU/FA plus irinotecan as first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer

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Trial Profile

Open, randomized, controlled, multicenter phase III study comparing 5FU/ FA [fluorouracil + folinic acid] plus irinotecan (FOLFIRI) plus cetuximab [Erbitux; Merck] versus 5FU/FA plus irinotecan as first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Dec 2021

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At a glance

  • Drugs Cetuximab (Primary) ; Fluorouracil; Folinic acid; Irinotecan
  • Indications Adenocarcinoma; Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms CRYSTAL
  • Sponsors Merck KGaA

    • Most Recent Events

    • 05 Oct 2021 Planned number of patients changed from 1080 to 1300.
    • 02 Mar 2017 According to a Merck KGaA media release, based on the data from this and other three studies (CTP: 15696, 37756 and 60760) the UK National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Determination (FAD) recommending the routine National Health Service (NHS) use of Erbitux (cetuximab) in combination with either FOLFIRI or FOLFOX as a first-line treatment for patients with RAS wild-type metastatic colorectal cancer (mCRC).
    • 02 Nov 2016 Results presented at the 19th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research

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