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.

Sponsored by: University of Chicago
Information provided by: University of Chicago

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

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

Official Title: A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients with N2/N3 Locally Advanced Head and Neck Cancer

Further Study Details: 
Primary Outcomes: Overall survival
Secondary Outcomes: Distant failure-free survival (DFFS); failure pattern; progression free survival; quality of life (QOL)
Expected Total Enrollment:  400

Study start: November 2004

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

Secondary

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 above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00117572

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

California
      USC University of Southern California Keck School of Medicine, Los Angeles,  California,  90033,  United States; Not yet recruiting
Parvesh Kumar, M.D.  323-865-3959    parveshk@usc.edu 
Linda Bailey-Theders  323-865-3072    baileyth@usc.edu 

Florida
      UM Sylvester Comprehensive Cancer Center, Miami,  Florida,  33136,  United States; Recruiting
Luis E. Raez, M.D.  305-243-4976    l.raez@miami.edu 
Andrea Gachupin-Garcia  305-243-3379    AGachupin@med.miami.edu 

Georgia
      Winship Cancer Institute, Emory University, Atlanta,  Georgia,  30322,  United States; Not yet recruiting
Dong M. Shin, M.D.  404-778-5990    dong_shin@emoryhealthcare.org 
Janelle Bowersox, R.N.  404-778-5959    janelle_bowersox@emoryhealthcare.org 

Illinois
      The University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
Ezra E.W. Cohen, M.D.  773-702-4137    ecohen@medicine.bsd.uchicago.edu 
Allison Dekker, R.N.  773-702-2068    adekker@medicine.bsd.uchicago.edu 

      Oncology Hematology Associates of Central Illinois, Peoria,  Illinois,  61615,  United States; Not yet recruiting
Sachdev P. Thomas, M.D.  309-243-3000    sthomas@ohaci.com  
Christina Truelove  309-243-3623    ctruelove@ohaci.com 

      Joliet Oncology Hematology Associates, Joliet,  Illinois,  60435,  United States; Recruiting
Sanjiv Modi, M.D.  815-725-1355    smodi@jolietoncology.com 
Jacque Davis  815-730-3098    jacqued@JolietOncology.com 

      Evanston Northwestern Healthcare, Evanston,  Illinois,  60201,  United States; Recruiting
Bruce E. Brockstein, M.D.  847-570-1489    b-brockstein@northwestern.edu 
Marie Neale  847-570-2106    mneale@enh.org 

Kansas
      University of Kansas Cancer Center, Kansas City,  Kansas,  66160,  United States; Recruiting
Chao Huang, M.D.  913-588-6029    Chao.Huang@med.va.gov 
Rebecca Clark-Snow  913-588-4714    rclark-snow@kumc.edu 

Michigan
      Henry Ford Health System, Detroit,  Michigan,  48202,  United States; Recruiting
Haythem Ali, M.D.  313-916-2576    hali1@hfhs.org 
Susan Oblak, R.N.  313-916-2438 

      Oncology Care Associates PLLC, St. Joseph,  Michigan,  49085,  United States; Recruiting
Eric Lester, M.D.  269-985-0029    oncology@parrett.net 
Kris Nickel, R.N.  269-985-0029  Ext. 126    krisnickel@oncology-care.com 

Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Patrick Gaffney, M.D.  612-625-1112    gaffn001@umn.edu 
Kate Cole, R.N.  612-625-5602    colex006@umn.edu 

Missouri
      Kansas City VA Medical Center, Kansas City,  Missouri,  64128,  United States; Recruiting
Chao Huang, M.D.  913-588-6029    Chao.Huang@med.va.gov 
Sarah Spencer, R.N.  816-861-4700  Ext. 57665    sarah.spencer@med.va.gov 

Tennessee
      University of Tennessee Cancer Institute, Memphis,  Tennessee,  38104,  United States; Not yet recruiting
Sandeep Samant, M.D.  901-722-0561    ssamant@utmem.edu 
Priscilla Adler  901-722-0665    padler@utcancer.com 

West Virginia
      West Virginia University/Mary Babb Randolph Cancer Center, Morgantown,  West Virginia,  26506,  United States; Not yet recruiting
Ramin Altaha, M.D.  304-293-4606    raltaha@hsc.wvu.edu 
Sylvia McEwuen  304-293-1683    smcewuen@hsc.wvu.edu 

Wisconsin
      Oncology Alliance, Milwaukee,  Wisconsin,  53215,  United States; Recruiting
Robert F. Taylor, M.D.  414-389-5520    rtaylor@oncologyalliance.com 
Barbara Ritter, R.N.  414-906-4480    414-906-4480 

Study chairs or principal investigators

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

More Information

Study ID Numbers:  IRB 13362B
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



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