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Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
This study is currently recruiting participants.
Verified by University of Chicago, February 2009
First Received: June 30, 2005   Last Updated: February 13, 2009   History of Changes
Sponsored by: 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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:


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: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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

Contacts
Contact: Ezra E.W. Cohen, M.D. 773-702-4137 ecohen@medicine.bsd.uchicago.edu
Contact: Allison Dekker, R.N. 773-702-2068 adekker@medicine.bsd.uchicago.edu

Locations
United States, California
USC University of Southern California Keck School of Medicine Recruiting
Los Angeles, California, United States, 90033
Contact: Parvesh Kumar, M.D.     323-865-3959     parveshk@usc.edu    
Contact: Linda Bailey-Theders     323-865-3072     baileyth@usc.edu    
United States, Florida
UM Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Luis E. Raez, M.D.     305-243-4976     l.raez@miami.edu    
Contact: Andrea Gachupin-Garcia     305-243-3379     AGachupin@med.miami.edu    
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Ezra E.W. Cohen, M.D.     773-702-4137     ecohen@medicine.bsd.uchicago.edu    
Contact: Allison Dekker, R.N.     773-702-2068     adekker@medicine.bsd.uchicago.edu    
Joliet Oncology Hematology Associates Recruiting
Joliet, Illinois, United States, 60435
Contact: Sanjiv Modi, M.D.     815-725-1355     smodi@jolietoncology.com    
Contact: Jacque Davis     815-730-3098     jacqued@JolietOncology.com    
Evanston Northwestern Healthcare Recruiting
Evanston, Illinois, United States, 60201
Contact: Bruce E. Brockstein, M.D.     847-570-1489     b-brockstein@northwestern.edu    
Contact: Marie Neale     847-570-2106     mneale@enh.org    
Weiss Memorial Hospital Recruiting
Chicago, Illinois, United States, 60640
Contact: Keith L Shulman, M.D.     773-564-5030     KSHULMAN@weisshospital.com    
Contact: Peggy Kotowski, R.N.     773-564-5041     pkotowsk@weisshospital.com    
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Mark Agulnik, M.D.     312-695-1222     m-agulnik@northwestern.edu    
Contact: Rachel A Cone     312-695-1357     r-cone@northwestern.edu    
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: John L Showel, M.D.     708-763-2700     John_L_Showel@rush.edu    
Contact: Deborah B Pach, R.N.         Deborah_B_Pach@rush.edu    
United States, Indiana
AP&S Clinic, LLC Recruiting
Terre Haute, Indiana, United States, 47807
Contact: Rafael Gallardo, M.D.     812-232-7121     RGallardo@APSClinic.com    
Contact: Cindy Thomas, R.N.     812-242-3632     CThomas@APSClinic.com    
Fort Wayne Medical Oncology/Hematology Inc. Recruiting
Fort Wayne, Indiana, United States, 46815
Contact: Leslie Edgar, R.N.     260-484-8830 ext 230     ledgar@fwmoh.com    
United States, Kansas
University of Kansas Cancer Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Chao Huang, M.D.     913-588-6029     Chao.Huang@med.va.gov    
Contact: Rebecca Clark-Snow     913-588-4714     rclark-snow@kumc.edu    
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Haythem Ali, M.D.     313-916-2576     hali1@hfhs.org    
Contact: Susan Oblak, R.N.     313-916-2438        
Oncology Care Associates PLLC Recruiting
St. Joseph, Michigan, United States, 49085
Contact: Eric Lester, M.D.     269-985-0029     oncology@parrett.net    
Contact: Kris Nickel, R.N.     269-985-0029 ext 126     krisnickel@oncology-care.com    
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Patrick Gaffney, M.D.     612-625-1112     gaffn001@umn.edu    
Contact: Kate Cole, R.N.     612-625-5602     colex006@umn.edu    
United States, Missouri
Kansas City VA Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Contact: Chao Huang, M.D.     913-588-6029     Chao.Huang@med.va.gov    
Contact: Sarah Spencer, R.N.     816-861-4700 ext 57665     sarah.spencer@med.va.gov    
United States, North Dakota
Roger Maris Cancer Center Not yet recruiting
Fargo, North Dakota, United States, 58122
Contact: Louis Geeraerts, M.D.     701-234-6161        
Contact: Peggy Erstad     701-234-2282     Peggy.Erstad@meritcare.com    
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Corey Langer, M.D.     215-214-3769     CJ_Langer@fccc.edu    
Contact: Charlotte Cione, R.N.     215-728-3614     Charlotte.Cione@fccc.edu    
United States, Tennessee
University of Tennessee Cancer Institute Recruiting
Memphis, Tennessee, United States, 38104
Contact: Sandeep Samant, M.D.     901-722-0561     ssamant@utmem.edu    
Contact: Priscilla Adler     901-722-0665     padler@utcancer.com    
United States, Texas
UT Health Science Center at San Antonio Not yet recruiting
San Antonio, Texas, United States, 78258
Contact: John G Kuhn, PharmD     210-567-8355     kuhn@uthscsa.edu    
Contact: Pam Sparks     210-593-2651     PSparks@ctrc.net    
United States, Wisconsin
Oncology Alliance Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Robert F. Taylor, M.D.     414-389-5520     rtaylor@oncologyalliance.com    
Contact: Barbara Ritter, R.N.     414-906-4480        
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:
No publications provided

Responsible Party: The University of Chicago ( Ezra E. W. Cohen, M.D. )
Study ID Numbers: IRB 13362B
Study First Received: June 30, 2005
Last Updated: February 13, 2009
ClinicalTrials.gov Identifier: NCT00117572     History of Changes
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

Study placed in the following topic categories:
Antimetabolites
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Immunologic Factors
Hydroxyurea
Paranasal Sinus Neoplasms
Laryngeal Carcinoma
Pharyngeal Neoplasms
Laryngeal Neoplasms
Sinus Cancer
Immunosuppressive Agents
Pharyngeal Diseases
Docetaxel
Cisplatin
Respiratory Tract Diseases
Nose Neoplasms
Fluorouracil
Head and Neck Neoplasms
Laryngeal Diseases
Stomatognathic Diseases

Additional relevant MeSH terms:
Antimetabolites
Otorhinolaryngologic Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Paranasal Sinus Neoplasms
Paranasal Sinus Diseases
Hydroxyurea
Antineoplastic Agents
Hematologic Agents
Physiological Effects of Drugs
Pharyngeal Neoplasms
Docetaxel
Neoplasms by Site
Respiratory Tract Diseases
Therapeutic Uses
Laryngeal Diseases
Nucleic Acid Synthesis Inhibitors
Respiratory Tract Neoplasms
Antisickling Agents
Otorhinolaryngologic Diseases
Enzyme Inhibitors
Laryngeal Neoplasms
Immunosuppressive Agents
Pharyngeal Diseases
Nose Diseases
Pharmacologic Actions
Neoplasms
Nose Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009