A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer
Phase III trial of induction therapy with docetaxel followed by chemoradiotherapy versus
chemoradiotherapy alone in patients with nodal stage N2 or N3 head and neck cancer
- To determine the effect on overall survival when induction chemotherapy is administered
prior to chemoradiotherapy in patients with N2 or N3 disease.
- To determine the effect of induction chemotherapy when administered prior to
chemoradiotherapy on distant failure-free survival, failure pattern, progression free
survival and quality of life.
- After eligibility is confirmed, patients will be randomized to one of two treatment
Arm A - Induction + chemoradiotherapy
Arm B - Chemoradiotherapy alone
- Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (day 1),
cisplatin (day 1), and 5-fluorouracil (days 1-5). Total duration of 6 weeks.
- Chemoradiotherapy: Five 14-day cycles of docetaxel (day 1), 5-fluorouracil (day 0-4),
and hydroxyurea (days 0-4) with twice daily radiation (days 1-5). Total duration of 10
- All patients will undergo surgical evaluation after chemoradiation for possible neck
- Upon completion of treatment, patients will be monitored every three months during the
first year, every six months during the second and third years, and annually
thereafter, up to five years.
- Patients will be followed for Quality of Life (QOL) during the course of treatment, as
well as annually thereafter, up to five years.
- An expected sample size of 400 patients will be enrolled for this study (200 per
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Everett E. Vokes, M.D.
University of Chicago
United States: Institutional Review Board
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Rush University Medical Center||Chicago, Illinois 60612-3824|
|University of Tennessee Cancer Institute||Memphis, Tennessee 38103|
|Evanston Northwestern Healthcare||Evanston, Illinois 60201|
|University of Minnesota||Minneapolis, Minnesota 55455|
|Northwestern University||Chicago, Illinois 60611|
|Henry Ford Health System||Detroit, Michigan 48202|
|Weiss Memorial Hospital||Chicago,, Illinois 60640|
|The University of Chicago||Chicago, Illinois 60637|
|University of Kansas Cancer Center||Kansas City, Kansas 66160|
|Fort Wayne Medical Oncology/Hematology Inc.||Fort Wayne, Indiana 46815|
|USC University of Southern California Keck School of Medicine||Los Angeles, California 90033|
|UM Sylvester Comprehensive Cancer Center||Miami, Florida 33136|
|Joliet Oncology Hematology Associates||Joliet, Illinois 60435|
|AP&S Clinic, LLC||Terre Haute, Indiana 47807|
|Oncology Care Associates PLLC||St. Joseph, Michigan 49085|
|Kansas City VA Medical Center||Kansas City, Missouri 64128|
|Roger Maris Cancer Center||Fargo, North Dakota 58122|
|UT Health Science Center at San Antonio||San Antonio, Texas 78258|
|Oncology Alliance||Milwaukee, Wisconsin 53215|