Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE) (DeCIDE)
Cancer of the Pharynx, Cancer of the Larynx, Cancer of the Nasal Cavity
About this trial
This is an interventional treatment trial for Cancer of the Pharynx focused on measuring Cancer of the Pharynx (Nasopharynx, Oropharynx, Hypopharynx), Cancer of the Nasal Cavity and Paranasal Sinuses
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck (excluding lip), or lymphoepithelioma No prior chemotherapy or radiotherapy Prior surgical therapy will consist only of incisional or excisional biopsy, and organ sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an existing primary tumor Karnofsky performance status of >= 70% Intact organ and bone marrow function Obtained informed consent Exclusion Criteria: Demonstration of metastatic disease (i.e. M1 disease). Patients with a history of severe allergic reaction to docetaxel or other drugs formulated with polysorbate 80. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, 5-fluorouracil, or hydroxyurea Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical cancer in situ, and other treated malignancies with no evidence of disease for at least 3 years. Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor. Any non-biopsy procedure must have taken place less than 3 months from initiating protocol treatment. Incomplete healing from previous surgery Pregnancy or breast feeding (men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician. Uncontrolled active infection unless curable with treatment of their cancer.
Sites / Locations
- USC University of Southern California Keck School of Medicine
- UM Sylvester Comprehensive Cancer Center
- Northwestern University
- Rush University Medical Center
- The University of Chicago
- Weiss Memorial Hospital
- Evanston Northwestern Healthcare
- Joliet Oncology Hematology Associates
- Fort Wayne Medical Oncology/Hematology Inc.
- AP&S Clinic, LLC
- University of Kansas Cancer Center
- Henry Ford Health System
- Oncology Care Associates PLLC
- University of Minnesota
- Kansas City VA Medical Center
- Roger Maris Cancer Center
- Fox Chase Cancer Center
- University of Tennessee Cancer Institute
- UT Health Science Center at San Antonio
- Oncology Alliance
- Clinic of Oncology, University Hospital Center Zagreb
- University Hospital for Tumors Zagreb
- Clinique Armoricaine de Radiologie
- NN Blokhin Russian Cancer Research Centre RAMS
- Republican Oncology Dispensary
- Hospital Clínico San Carlos
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Induction plus chemoradiotherapy
Chemoradiotherapy
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.