Clinical trial NCT00117572: Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2005-07-07
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Overall Survival: Time From Randomization to Death From Any Cause
timeFrame: Up to 6 years
Secondary outcomes:
measure: Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause
timeFrame: Up to 6 years
measure: Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause
timeFrame: Up to 6 years
measure: Failure Pattern (Local/Regional Recurrence)
timeFrame: Up to 6 years
measure: Failure Pattern (Distant Recurrence)
timeFrame: Up to 6 years
measure: Quality of Life (FACT H&N)
timeFrame: 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.
measure: Quality of Life (Normalcy of Diet)
timeFrame: 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.
measure: Quality of Life (Speech)
timeFrame: 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.
measure: Quality of Life (McMaster)
timeFrame: 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.
measure: Quality of Life (FACT H&N)
timeFrame: Change from baseline to 1 year (1 year-pre)
measure: Quality of Life (Normalcy of Diet)
timeFrame: Change from baseline to 1 year (1 year-pre)
measure: Quality of Life (Speech)
timeFrame: Change from baseline to 1 year (1 year-pre)
measure: Quality of Life (McMaster)
timeFrame: Change from baseline to 1 year (1 year-pre)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC University of Southern California Keck School of Medicine
state: California
city: Miami
country: United States
facility: UM Sylvester Comprehensive Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Chicago
country: United States
facility: Weiss Memorial Hospital
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology Hematology Associates
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology/Hematology Inc.
state: Indiana
city: Terre Haute
country: United States
facility: AP&S Clinic, LLC
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Joseph
country: United States
facility: Oncology Care Associates PLLC
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Fargo
country: United States
facility: Roger Maris Cancer Center
state: North Dakota
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Cancer Institute
state: Tennessee
city: San Antonio
country: United States
facility: UT Health Science Center at San Antonio
state: Texas
city: Milwaukee
country: United States
facility: Oncology Alliance
state: Wisconsin
city: Zagreb
country: Croatia
facility: Clinic of Oncology, University Hospital Center Zagreb
city: Zagreb
country: Croatia
facility: University Hospital for Tumors Zagreb
city: Saint Brieuc
country: France
facility: Clinique Armoricaine de Radiologie
city: Moscow
country: Russian Federation
facility: NN Blokhin Russian Cancer Research Centre RAMS
city: UFA
country: Russian Federation
facility: Republican Oncology Dispensary
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: University of Chicago
name: Everett Vokes, M.D.
role: PRINCIPAL_INVESTIGATOR
References: