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

Primary Purpose

Cancer of the Pharynx, Cancer of the Larynx, Cancer of the Nasal Cavity

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
docetaxel
cisplatin
hydroxyurea
fluorouracil
chemotherapy
radiotherapy
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of the Pharynx focused on measuring Cancer of the Pharynx (Nasopharynx, Oropharynx, Hypopharynx), Cancer of the Nasal Cavity and Paranasal Sinuses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC University of Southern California Keck School of Medicine
  • UM Sylvester Comprehensive Cancer Center
  • Northwestern University
  • Rush University Medical Center
  • The University of Chicago
  • Weiss Memorial Hospital
  • Evanston Northwestern Healthcare
  • Joliet Oncology Hematology Associates
  • Fort Wayne Medical Oncology/Hematology Inc.
  • AP&S Clinic, LLC
  • University of Kansas Cancer Center
  • Henry Ford Health System
  • Oncology Care Associates PLLC
  • University of Minnesota
  • Kansas City VA Medical Center
  • Roger Maris Cancer Center
  • Fox Chase Cancer Center
  • University of Tennessee Cancer Institute
  • UT Health Science Center at San Antonio
  • Oncology Alliance
  • Clinic of Oncology, University Hospital Center Zagreb
  • University Hospital for Tumors Zagreb
  • Clinique Armoricaine de Radiologie
  • NN Blokhin Russian Cancer Research Centre RAMS
  • Republican Oncology Dispensary
  • Hospital Clínico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Induction plus chemoradiotherapy

Chemoradiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall Survival: Time From Randomization to Death From Any Cause
Survival rates over 6 years.

Secondary Outcome Measures

Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause
DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause
Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause
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
Failure Pattern (Local/Regional Recurrence)
Percentage of patients with local/regional recurrence
Failure Pattern (Distant Recurrence)
Percentage of patients with distant recurrence
Quality of Life (FACT H&N)
FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
Quality of Life (Normalcy of Diet)
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Quality of Life (Speech)
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Quality of Life (McMaster)
McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
Quality of Life (FACT H&N)
FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
Quality of Life (Normalcy of Diet)
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Quality of Life (Speech)
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Quality of Life (McMaster)
McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)

Full Information

First Posted
June 30, 2005
Last Updated
April 6, 2018
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00117572
Brief Title
Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
Acronym
DeCIDE
Official Title
A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Pharynx, Cancer of the Larynx, Cancer of the Nasal Cavity, Paranasal Sinus Neoplasms, Cancer of the Oral Cavity
Keywords
Cancer of the Pharynx (Nasopharynx, Oropharynx, Hypopharynx), Cancer of the Nasal Cavity and Paranasal Sinuses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induction plus chemoradiotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Chemoradiotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
75 mg/m2 on day 1
Intervention Type
Drug
Intervention Name(s)
hydroxyurea
Intervention Description
Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Description
750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
Intervention Type
Procedure
Intervention Name(s)
chemotherapy
Intervention Description
See protocol for details
Intervention Type
Procedure
Intervention Name(s)
radiotherapy
Intervention Description
See protocol for details
Primary Outcome Measure Information:
Title
Overall Survival: Time From Randomization to Death From Any Cause
Description
Survival rates over 6 years.
Time Frame
Up to 6 years
Secondary Outcome Measure Information:
Title
Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause
Description
DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause
Time Frame
Up to 6 years
Title
Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause
Description
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
Time Frame
Up to 6 years
Title
Failure Pattern (Local/Regional Recurrence)
Description
Percentage of patients with local/regional recurrence
Time Frame
Up to 6 years
Title
Failure Pattern (Distant Recurrence)
Description
Percentage of patients with distant recurrence
Time Frame
Up to 6 years
Title
Quality of Life (FACT H&N)
Description
FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
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.
Title
Quality of Life (Normalcy of Diet)
Description
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
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.
Title
Quality of Life (Speech)
Description
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
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.
Title
Quality of Life (McMaster)
Description
McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
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.
Title
Quality of Life (FACT H&N)
Description
FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
Time Frame
Change from baseline to 1 year (1 year-pre)
Title
Quality of Life (Normalcy of Diet)
Description
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Time Frame
Change from baseline to 1 year (1 year-pre)
Title
Quality of Life (Speech)
Description
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Time Frame
Change from baseline to 1 year (1 year-pre)
Title
Quality of Life (McMaster)
Description
McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
Time Frame
Change from baseline to 1 year (1 year-pre)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Everett Vokes, M.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC University of Southern California Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UM Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Joliet Oncology Hematology Associates
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Fort Wayne Medical Oncology/Hematology Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46815
Country
United States
Facility Name
AP&S Clinic, LLC
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47807
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Oncology Care Associates PLLC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Kansas City VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Tennessee Cancer Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
UT Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Oncology Alliance
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Clinic of Oncology, University Hospital Center Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital for Tumors Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinique Armoricaine de Radiologie
City
Saint Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
NN Blokhin Russian Cancer Research Centre RAMS
City
Moscow
Country
Russian Federation
Facility Name
Republican Oncology Dispensary
City
UFA
Country
Russian Federation
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

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

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