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Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer

NCT00286130 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-05-01

No results posted yet for this study

Summary

In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety.

The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first

Conditions

Interventions

DRUG

Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan

DRUG

FOLFOX 6

FOLFOX 6: * Oxaliplatin 100 mg/m² d1 concurrent with * Leucovorin 400 mg/m², followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:

DRUG

FOLFIRI

FOLFIRI: * Irinotecan 180 mg/m² day 1 concurrent with * Leucovorin 400 mg/m² followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks

Sponsors & Collaborators

  • Central European Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • Werner Scheithauer, MD · Dep. of Internal Medicine I, Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Completion
2007-10-31

Countries

  • Austria
  • Bosnia and Herzegovina
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Hungary
  • Israel
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00286130 on ClinicalTrials.gov