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Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer

NCT00468169 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-10-09

Study results available
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Summary

The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.

Conditions

Interventions

DRUG

Cetuximab

250mg/m2(day 1, weekly x 10);

DRUG

5-FU

600 mg/m2/day; days 0-5 (120 h total) every other week x 5

DRUG

Hydroxyurea

500 mg PO BID, days 0-5 every other week x 5

RADIATION

Twice-daily radiation

150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)

DRUG

Cisplatin

100 mg/m2, week 1 and 4 on day 1 (or 2)

RADIATION

Accelerated fraction radiotherapy with concomitant boost

72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.

Sponsors & Collaborators

Principal Investigators

  • Everett E Vokes, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2012-08-31
Completion
2012-11-30

Countries

  • United States

Study Locations

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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 NCT00468169 on ClinicalTrials.gov