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

Phase 2

Completed

• Conditions: Head and Neck

• Registration Number: NCT01693718
• Lead Sponsor: University of Chicago

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2003-09
• Study Completion: 2004-09
• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-26
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response Rates	2-5 years	To evaluate the activity of 5 cycles of C-FHX/G-CSF in previously untreated patients with stage II and IV locoregionally advanced head and neck cancer.

Secondary Outcome Measures

Name	Time	Method
Side effects of study regimen	2-5 years	To determine the pattern and degree of clinical toxicity of this regimen
Feasibility of administering adjuvant CRA and interferon alfa2a	2-5 years	To determine the feasibility of administering adjuvant CRA and interferon alfa2a for up to one or until tumor progression in patients completing local therapy.

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States