Treatment of Patients With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before, Under and After Radiation and With Adding Cetuximab to K-RAS Wild-type Patients

Phase 2

• Conditions: Rectum Cancer
• Interventions: Drug: cetuximab

• Registration Number: NCT00964457
• Lead Sponsor: Copenhagen University Hospital at Herlev

Brief Summary

response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer

Detailed Description

Dynamic MRI will be used to monitor the effect of the treatment and will be compared to pathologic results.

Study Timeline

• Status Verified: 2009-08
• Study Start: 2009-08
• Study First Submitted: 2009-08-21
• Study First Submitted QC: 2009-08-24
• Last Update Submitted: 2009-08-24
• Study First Posted: 2009-08-25
• Last Update Posted: 2009-08-25
• Primary Completion: 2012-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• advanced rectum cancer

Exclusion Criteria

• prior radiation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capecitabine, oxaliplatin	cetuximab	-
capecitabine, oxaliplatin and cetuximab	cetuximab	capecitabine, oxaliplatin ane cetuximab

Primary Outcome Measures

Name	Time	Method
response rate	3 years

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark