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A Multicenter Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer

NCT01693718 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-01-29

No results posted yet for this study

Summary

The goal of the study is to test a particular combination of drugs and determine their ability to completely eliminate head and neck cancer.

Conditions

Interventions

DRUG

Hydroxyurea

Hydroxyurea at 1gm(PO)12hrs x 11days(2gm/day). The first daily dose of hydroxyurea on days 1-5 is given 2 hrs prior to the first fraction of daily radiotherapy.

DRUG

5- Fluorouracil

Start continuous infusion of 5-Fluorouracil at 800mg/m2/day x 5 days (120 hrs. Radiation therapy is administered twice daily at 150 cGY per fraction, every other week with chemotherapy.

DRUG

Cisplatin

Cisplatin 100mg/m2 I.V. on the evening of the day 1, on cycles 1,3,and 5 only in 200cc NS IV over 2 h. Ensure adequate hydration to keep urine output \> 100 cc/ hour.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Everett Vokes, MD · The University of Chicago Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2003-09-30
Completion
2004-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01693718 on ClinicalTrials.gov