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Brief Title: Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
Official Title: A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer
Study ID: NCT00117572
Brief Summary: The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.
Detailed Description: TRIAL DESIGN: 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 OBJECTIVES: Primary * To determine the effect on overall survival when induction chemotherapy is administered prior to chemoradiotherapy in patients with N2 or N3 disease. Secondary * 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. TREATMENT PLAN: * After eligibility is confirmed, patients will be randomized to one of two treatment arms: 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 weeks. * All patients will undergo surgical evaluation after chemoradiation for possible neck dissection. * 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 seven years. * Patients will be followed for Quality of Life (QOL) during the course of treatment, as well as annually thereafter, up to five years. PROJECTED ACCRUAL: * An expected sample size of 400 patients will be enrolled for this study (200 per treatment arm).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
USC University of Southern California Keck School of Medicine, Los Angeles, California, United States
UM Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Northwestern University, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
The University of Chicago, Chicago, Illinois, United States
Weiss Memorial Hospital, Chicago, Illinois, United States
Evanston Northwestern Healthcare, Evanston, Illinois, United States
Joliet Oncology Hematology Associates, Joliet, Illinois, United States
Fort Wayne Medical Oncology/Hematology Inc., Fort Wayne, Indiana, United States
AP&S Clinic, LLC, Terre Haute, Indiana, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
Henry Ford Health System, Detroit, Michigan, United States
Oncology Care Associates PLLC, Saint Joseph, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Kansas City VA Medical Center, Kansas City, Missouri, United States
Roger Maris Cancer Center, Fargo, North Dakota, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Tennessee Cancer Institute, Memphis, Tennessee, United States
UT Health Science Center at San Antonio, San Antonio, Texas, United States
Oncology Alliance, Milwaukee, Wisconsin, United States
Clinic of Oncology, University Hospital Center Zagreb, Zagreb, , Croatia
University Hospital for Tumors Zagreb, Zagreb, , Croatia
Clinique Armoricaine de Radiologie, Saint Brieuc, , France
NN Blokhin Russian Cancer Research Centre RAMS, Moscow, , Russian Federation
Republican Oncology Dispensary, UFA, , Russian Federation
Hospital Clínico San Carlos, Madrid, , Spain
Name: Everett Vokes, M.D.
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR