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Open, randomized, controlled, multicenter phase II study comparing 5-FU/FA [fluorouracil + folinic acid] plus oxaliplatin (FOLFOX-4) plus cetuximab versus 5-FU/FA plus oxaliplatin (FOLFOX-4) as first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer

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Trial Profile

Open, randomized, controlled, multicenter phase II study comparing 5-FU/FA [fluorouracil + folinic acid] plus oxaliplatin (FOLFOX-4) plus cetuximab versus 5-FU/FA plus oxaliplatin (FOLFOX-4) as first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Oct 2021

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At a glance

  • Drugs Cetuximab (Primary) ; Fluorouracil; Folinic acid; Oxaliplatin
  • Indications Colorectal cancer
  • Focus Therapeutic Use
  • Acronyms OPUS
  • Sponsors Merck KGaA
  • Most Recent Events

    • 02 Mar 2017 According to a Merck KGaA media release, based on the data from this and other three studies (CTP: 8930, 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).
    • 18 Jan 2014 Results of an analysis investigating the accuracy of radiographical data presented at the 2014 Gastrointestinal Cancers Symposium.
    • 18 Jan 2014 Results of an analysis based on RAS mutation status presented at the 2014 Gastrointestinal Cancers Symposium.
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