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Adjuvant Cetuximab and Chemoradiation in Head and Neck Cancer

NCT00791141 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-01-23

No results posted yet for this study

Summary

This multicenter, open-label, uncontrolled phase II trial evaluates safety and efficacy of post-operative chemoradiation in combination with cetuximab in squamous cell carcinoma of the head and neck.

Conditions

Interventions

DRUG

Cetuximab

Loading dose prior to chemoradiotherapy 400 mg/m², followed by every week infusion of 250 mg/m² during chemoradiotherapy. After chemoradiotherapy every 2 week infusions of 500 mg/m² over 6 months.

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Wilfried Budach, Prof. Dr. · Department of Radiotherapy and Radiological Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2013-04-30
Completion
2013-09-30

Countries

  • Germany

Study Locations

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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 NCT00791141 on ClinicalTrials.gov