A Multicenter Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT01693718|
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : September 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck||Drug: Hydroxyurea Drug: 5- Fluorouracil Drug: Cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase II Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||September 2003|
|Actual Study Completion Date :||September 2004|
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.
- Response Rates [ Time Frame: 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.
- Feasibility of administering adjuvant CRA and interferon alfa2a [ Time Frame: 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.
- Side effects of study regimen [ Time Frame: 2-5 years ]To determine the pattern and degree of clinical toxicity of this regimen
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693718
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60653|
|Principal Investigator:||Everett Vokes, MD||The University of Chicago Medical Center|