drugset / Trial / NCT01228734

A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients

NCT01228734

Phase 3 Completed 553 enrolled Merck KGaA, Darmstadt, Germany
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to assess whether the progression free survival (PFS) time with FOLFOX-4 plus cetuximab is longer than that with FOLFOX-4 alone as first-line treatment for mCRC in Chinese subjects with RAS wild-type tumors.

Timeline

Start
2010-09-09
Primary completion
2016-01-25
Completion
2018-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2
Background Leucovorin Small molecule 200 mg/m2
Background Oxaliplatin Small molecule 85 mg/m2
Background fluorouracil Small molecule 400 mg/m2
Background fluorouracil Small molecule 600 mg/m2

Indications