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Safety and Efficacy Study of mFOLFOX-6 Plus Cetuximab for 8 Cycles Followed by mFOLFOX-6 Plus Cetuximab or Single Agent Cetuximab as Maintenance Therapy in Patients With Metastatic Colorectal Cancer and WT KRAS Tumours

2014-08-27 03:12:16 | BioPortfolio

Summary

The purpose of the study is to evaluate the efficacy and safety of the combination of mFOLFOX-6 plus cetuximab for 8 cycles followed by mFOLFOX-6 plus cetuximab or single agent (s/a) cetuximab as maintenance therapy in patients (pts) with metastatic colorectal cancer (mCRC).

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Metastatic Colorectal Cancer

Intervention

mFOLFOX-6 + cetuximab until disease progression or early withdrawal., 8 cycles of mFOLFOX-6 + cetuximab, followed by cetuximab alone until disease progression or early withdrawal.

Location

Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid
Spain
28046

Status

Not yet recruiting

Source

Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:16-0400

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