NCT01693718

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 59 Years
• Healthy volunteers: Not accepted

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

• Head and Neck

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-03-01
• Primary completion: 2003-09-01
• Completion: 2004-09-01
• First posted: 2012-09-26
• Last updated: 2024-01-29

Locations

1 site across 1 country: United States