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

Sponsor:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00117572

Purpose

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.

Condition	Intervention	Phase
Cancer of the Pharynx Cancer of the Larynx Cancer of the Nasal Cavity Paranasal Sinus Neoplasms Cancer of the Oral Cavity	Drug: docetaxel Drug: cisplatin Drug: hydroxyurea Drug: fluorouracil Procedure: chemotherapy Procedure: radiotherapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Fluorouracil Cisplatin Docetaxel Hydroxyurea

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Overall survival [ Time Frame: Indefinitely ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Distant failure-free survival (DFFS) [ Time Frame: Indefinitely ] [ Designated as safety issue: No ]
failure pattern [ Time Frame: Indefinitely ] [ Designated as safety issue: No ]
progression free survival [ Time Frame: Indefinitely ] [ Designated as safety issue: No ]
quality of life (QOL) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	November 2004
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: docetaxel 75 mg/m2 on day 1 Drug: cisplatin 75 mg/m2 on day 1 Drug: hydroxyurea Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) Drug: fluorouracil 750 mg/m2/day on days 1-5 of induction Procedure: chemotherapy See protocol for details Procedure: radiotherapy See protocol for details
Active Comparator: 2	Drug: hydroxyurea Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) Procedure: chemotherapy See protocol for details Procedure: radiotherapy See protocol for details

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 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.

PROJECTED ACCRUAL:

An expected sample size of 400 patients will be enrolled for this study (200 per treatment arm).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117572

Locations

United States, California
USC University of Southern California Keck School of Medicine
Los Angeles, California, United States, 90033
United States, Florida
UM Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
Joliet Oncology Hematology Associates
Joliet, Illinois, United States, 60435
United States, Indiana
Fort Wayne Medical Oncology/Hematology Inc.
Fort Wayne, Indiana, United States, 46815
AP&S Clinic, LLC
Terre Haute, Indiana, United States, 47807
United States, Kansas
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Oncology Care Associates PLLC
St. Joseph, Michigan, United States, 49085
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
United States, North Dakota
Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
University of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38104
United States, Texas
UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78258
United States, Wisconsin
Oncology Alliance
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:	Everett E. Vokes, M.D.	University of Chicago
Principal Investigator:	Ezra E.W. Cohen, M.D.	University of Chicago

More Information

Additional Information:

Study Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ezra E. W. Cohen, M.D., The University of Chicago
ClinicalTrials.gov Identifier:	NCT00117572 History of Changes
Other Study ID Numbers:	IRB 13362B
Study First Received:	June 30, 2005
Last Updated:	September 23, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Cancer of the Pharynx (Nasopharynx, Oropharynx, Hypopharynx)
Cancer of the Nasal Cavity and Paranasal Sinuses

Additional relevant MeSH terms:

Neoplasms
Laryngeal Neoplasms
Head and Neck Neoplasms
Paranasal Sinus Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Nose Neoplasms
Nose Diseases
Paranasal Sinus Diseases
Pharyngeal Diseases

Stomatognathic Diseases
Docetaxel
Cisplatin
Fluorouracil
Hydroxyurea
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 12, 2012