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Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck

NCT01979211 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-29

Study results available
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Summary

The standard treatment of surgery followed by radiation therapy can stop tumors from growing in the head and neck region in most patients. However, the cancer can recur or can spread to other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development. It was approved by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head and neck cancer.

The purpose of this study is to determine how easily cetuximab can be added to treatment with radiation therapy in patients with cutaneous cancer of the head and neck. This study will also look at how well cetuximab added to radiation therapy works over time and how well this treatment is tolerated.

Conditions

Interventions

DRUG

Cetuximab

400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7

RADIATION

Radiation Therapy

Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Vinita Takiar, MD · University of Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2022-01-19
Completion
2022-01-19

Countries

  • United States

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 NCT01979211 on ClinicalTrials.gov