Status:
COMPLETED
Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
Lead Sponsor:
University of Chicago
Conditions:
Cancer of the Pharynx
Cancer of the Larynx
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. Inductio...
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: ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT00117572
Start Date
November 1 2004
End Date
December 1 2016
Last Update
April 9 2018
Active Locations (26)
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1
USC University of Southern California Keck School of Medicine
Los Angeles, California, United States, 90033
2
UM Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Rush University Medical Center
Chicago, Illinois, United States, 60612