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Preoperative Chemoradiation With Capecitabine and Cetuximab

NCT00297128 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2011-12-30

No results posted yet for this study

Summary

* feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
* collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status

Conditions

Interventions

DRUG

Capecitabine

825 mg/m2 bid (on each therapy day of first 4 therapy weeks)

DRUG

Cetuximab

400mg/m2 week 1, 250mg/m2 week 2-4

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Merck Gesellschaft mbH, Austria

    collaborator INDUSTRY

  • Austrian Breast & Colorectal Cancer Study Group

    lead NETWORK

Principal Investigators

  • Josef Thaler, MD · Austrian Breast & Colorectal Cancer Study Group

  • Joerg Tschmelitsch, MD · Austrian Breast & Colorectal Cancer Study Group

  • Alexander de Vries, MD · Austrian Breast & Colorectal Cancer Study Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2011-08-31
Completion
2011-11-30

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00297128 on ClinicalTrials.gov