MedTrace Logo

A Study of Chemoradiotherapy for Intermediate Stage/Selected Stage IV Cancers of the Head and Neck

NCT00203905 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-01-17

No results posted yet for this study

Summary

The primary objective of the study is to evaluate time to progression in eligible patients with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus when treated with the concomitant chemoradiotherapy regimen of bevacizumab/5-fluorouracil (5-FU)/hydroxyurea/radiation therapy (B-FHX) in comparison to 5-fluorouracil hydroxyurea (FHX) alone.

Conditions

Interventions

DRUG

5-Fluorouracil, Hydroxyurea-[FHX], Bevacizumab

Hydroxyurea at 500 mg PO q 12 hours x 6 days; Bevacizumab at 10 mg/kg as a 90-minute infusion; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours)

DRUG

5-Fluorouracil, Hydroxyurea-[FHX]

Hydroxyurea at 500 mg PO q 12 hours x 6 days; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours)

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Everett Vokes, M.D. · 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
2004-01-31
Primary Completion
2007-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00203905 on ClinicalTrials.gov