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
Price :
$35
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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
- 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.