Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)

Completed · Phase 3

Conditions studied: Cancer of the Pharynx, Cancer of the Larynx, Cancer of the Nasal Cavity, Paranasal Sinus Neoplasms, Cancer of the Oral Cavity

In brief

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.

Key facts

Study ID

NCT00117572

Run by

University of Chicago

People needed

285

Starts

2004-11-01

Expected to finish

2016-12-01

Last updated by the study team

2018-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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, Russia
• Republican Oncology Dispensary — Ufa, Russia

Full record on ClinicalTrials.gov

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