# 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

> **NCT01161316** · PHASE2 · COMPLETED · sponsor: **Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)** · enrollment: 194 (actual)

## Conditions studied

- Metastatic Colorectal Cancer

## Interventions

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

## Key facts

- **NCT ID:** NCT01161316
- **Lead sponsor:** Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-08
- **Primary completion:** 2015-06
- **Final completion:** 2015-06
- **Target enrollment:** 194 (ACTUAL)
- **Last updated:** 2015-07-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01161316

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01161316, "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". Retrieved via AI Analytics 2026-07-03 from https://api.ai-analytics.org/clinical/NCT01161316. Licensed CC0.

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