Docetaxel Based Chemotherapy Plus Or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE) - Article Cancer Chemotherapy
Clinical Trial: Docetaxel Based Chemotherapy Plus Or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
This study is currently recruiting patients.
|Cancer of the Pharynx |
Cancer of the Larynx
Cancer of the Nasal Cavity
Paranasal Sinus Neoplasms
Cancer of the Oral Cavity
| Drug: docetaxel |
|Phase III |
MedlinePlus related topics: Head and Neck Cancer; Nasal Cancer; Oral Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Secondary Outcomes: Distant failure-free survival (DFFS); failure pattern; progression free survival; quality of life (QOL)
Expected Total Enrollment: 400
Study start: November 2004
- 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 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 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 treatment arm).
- 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
- 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.
Location and Contact Information
Allison Dekker, R.N. 773-702-2068 email@example.com
USC University of Southern California Keck School of Medicine, Los Angeles, California, 90033, United States; Not yet recruiting
Linda Bailey-Theders 323-865-3072 firstname.lastname@example.org
UM Sylvester Comprehensive Cancer Center, Miami, Florida, 33136, United States; Recruiting
Andrea Gachupin-Garcia 305-243-3379 AGachupin@med.miami.edu
Winship Cancer Institute, Emory University, Atlanta, Georgia, 30322, United States; Not yet recruiting
Janelle Bowersox, R.N. 404-778-5959 email@example.com
The University of Chicago, Chicago, Illinois, 60637, United States; Recruiting
Allison Dekker, R.N. 773-702-2068 firstname.lastname@example.org
Oncology Hematology Associates of Central Illinois, Peoria, Illinois, 61615, United States; Not yet recruiting
Christina Truelove 309-243-3623 email@example.com
Joliet Oncology Hematology Associates, Joliet, Illinois, 60435, United States; Recruiting
Jacque Davis 815-730-3098 jacqued@JolietOncology.com
Evanston Northwestern Healthcare, Evanston, Illinois, 60201, United States; Recruiting
Marie Neale 847-570-2106 firstname.lastname@example.org
University of Kansas Cancer Center, Kansas City, Kansas, 66160, United States; Recruiting
Rebecca Clark-Snow 913-588-4714 email@example.com
Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Susan Oblak, R.N. 313-916-2438
Oncology Care Associates PLLC, St. Joseph, Michigan, 49085, United States; Recruiting
Kris Nickel, R.N. 269-985-0029 Ext. 126 firstname.lastname@example.org
University of Minnesota, Minneapolis, Minnesota, 55455, United States; Recruiting
Kate Cole, R.N. 612-625-5602 email@example.com
Kansas City VA Medical Center, Kansas City, Missouri, 64128, United States; Recruiting
Sarah Spencer, R.N. 816-861-4700 Ext. 57665 firstname.lastname@example.org
University of Tennessee Cancer Institute, Memphis, Tennessee, 38104, United States; Not yet recruiting
Priscilla Adler 901-722-0665 email@example.com
West Virginia University/Mary Babb Randolph Cancer Center, Morgantown, West Virginia, 26506, United States; Not yet recruiting
Sylvia McEwuen 304-293-1683 firstname.lastname@example.org
Oncology Alliance, Milwaukee, Wisconsin, 53215, United States; Recruiting
Barbara Ritter, R.N. 414-906-4480 414-906-4480
Everett E. Vokes, M.D., Principal Investigator, University of Chicago
Ezra E.W. Cohen, M.D., Principal Investigator, University of Chicago
Record last reviewed: April 2005
Last Updated: July 25, 2005
Record first received: July 6, 2005
ClinicalTrials.gov Identifier: NCT00117572
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26