- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00117572
Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE) (DeCIDE)
A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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 seven 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).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Zagreb, Croatia, 10000
- Clinic of Oncology, University Hospital Center Zagreb
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Zagreb, Croatia, 10000
- University Hospital for Tumors Zagreb
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Saint Brieuc, France, 22000
- Clinique Armoricaine de Radiologie
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Moscow, Russian Federation
- NN Blokhin Russian Cancer Research Centre RAMS
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UFA, Russian Federation
- Republican Oncology Dispensary
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Madrid, Spain, 28040
- Hospital Clinico San Carlos
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California
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Los Angeles, California, United States, 90033
- USC University of Southern California Keck School of Medicine
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Florida
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Miami, Florida, United States, 33136
- UM Sylvester Comprehensive Cancer Center
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Chicago, Illinois, United States, 60637
- The University of Chicago
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Chicago, Illinois, United States, 60640
- Weiss Memorial Hospital
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Evanston, Illinois, United States, 60201
- Evanston Northwestern Healthcare
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Joliet, Illinois, United States, 60435
- Joliet Oncology Hematology Associates
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Indiana
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Fort Wayne, Indiana, United States, 46815
- Fort Wayne Medical Oncology/Hematology Inc.
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Terre Haute, Indiana, United States, 47807
- AP&S Clinic, LLC
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Cancer Center
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Saint Joseph, Michigan, United States, 49085
- Oncology Care Associates PLLC
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Missouri
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Kansas City, Missouri, United States, 64128
- Kansas City VA Medical Center
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North Dakota
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Fargo, North Dakota, United States, 58122
- Roger Maris Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Tennessee
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Memphis, Tennessee, United States, 38104
- University of Tennessee Cancer Institute
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Texas
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San Antonio, Texas, United States, 78258
- UT Health Science Center at San Antonio
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Wisconsin
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Milwaukee, Wisconsin, United States, 53215
- Oncology Alliance
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Induction plus chemoradiotherapy
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. |
75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
75 mg/m2 on day 1
Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
See protocol for details
See protocol for details
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Active Comparator: Chemoradiotherapy
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5).
Total duration of 10 weeks.
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75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
See protocol for details
See protocol for details
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Survival: Time From Randomization to Death From Any Cause
Time Frame: Up to 6 years
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Survival rates over 6 years.
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Up to 6 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause
Time Frame: Up to 6 years
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DFFS rates over 6 years.
DFFS is time from randomization to distant recurrence or death from any cause
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Up to 6 years
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Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause
Time Frame: Up to 6 years
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Recurrence-free survival rates over 6 years.
Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause
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Up to 6 years
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Failure Pattern (Local/Regional Recurrence)
Time Frame: Up to 6 years
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Percentage of patients with local/regional recurrence
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Up to 6 years
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Failure Pattern (Distant Recurrence)
Time Frame: Up to 6 years
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Percentage of patients with distant recurrence
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Up to 6 years
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Quality of Life (FACT H&N)
Time Frame: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
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FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
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Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
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Quality of Life (Normalcy of Diet)
Time Frame: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
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Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
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Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
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Quality of Life (Speech)
Time Frame: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
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Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
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Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
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Quality of Life (McMaster)
Time Frame: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
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McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
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Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
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Quality of Life (FACT H&N)
Time Frame: Change from baseline to 1 year (1 year-pre)
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FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
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Change from baseline to 1 year (1 year-pre)
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Quality of Life (Normalcy of Diet)
Time Frame: Change from baseline to 1 year (1 year-pre)
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Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
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Change from baseline to 1 year (1 year-pre)
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Quality of Life (Speech)
Time Frame: Change from baseline to 1 year (1 year-pre)
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Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
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Change from baseline to 1 year (1 year-pre)
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Quality of Life (McMaster)
Time Frame: Change from baseline to 1 year (1 year-pre)
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McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
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Change from baseline to 1 year (1 year-pre)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Everett Vokes, M.D., University of Chicago
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Otorhinolaryngologic Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Paranasal Sinus Diseases
- Nose Diseases
- Laryngeal Diseases
- Nose Neoplasms
- Head and Neck Neoplasms
- Laryngeal Neoplasms
- Pharyngeal Neoplasms
- Paranasal Sinus Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antisickling Agents
- Docetaxel
- Cisplatin
- Fluorouracil
- Hydroxyurea
Other Study ID Numbers
- 13362B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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