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

Cancer of the Larynx Clinical Trial

— DeCIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117572
• Other study ID #: 13362B
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: April 6, 2018
• Start date: November 2004
• Est. completion date: December 2016

Study information

• Verified date: April 2018
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of the Larynx
• Cancer of the Nasal Cavity
• Cancer of the Oral Cavity
• Cancer of the Pharynx
• Head and Neck Neoplasms
• Laryngeal Neoplasms
• Paranasal Sinus Neoplasms
• Pharyngeal Neoplasms

Intervention

Drug:
• docetaxel
75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
• cisplatin
75 mg/m2 on day 1
• hydroxyurea
Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
• fluorouracil
750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)

Procedure:
• chemotherapy
See protocol for details
• radiotherapy
See protocol for details

Locations

Country	Name	City	State
Croatia	Clinic of Oncology, University Hospital Center Zagreb	Zagreb
Croatia	University Hospital for Tumors Zagreb	Zagreb
France	Clinique Armoricaine de Radiologie	Saint Brieuc
Russian Federation	NN Blokhin Russian Cancer Research Centre RAMS	Moscow
Russian Federation	Republican Oncology Dispensary	UFA
Spain	Hospital Clínico San Carlos	Madrid
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The University of Chicago	Chicago	Illinois
United States	Weiss Memorial Hospital	Chicago	Illinois
United States	Henry Ford Health System	Detroit	Michigan
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	Roger Maris Cancer Center	Fargo	North Dakota
United States	Fort Wayne Medical Oncology/Hematology Inc.	Fort Wayne	Indiana
United States	Joliet Oncology Hematology Associates	Joliet	Illinois
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	USC University of Southern California Keck School of Medicine	Los Angeles	California
United States	University of Tennessee Cancer Institute	Memphis	Tennessee
United States	UM Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Oncology Alliance	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Oncology Care Associates PLLC	Saint Joseph	Michigan
United States	UT Health Science Center at San Antonio	San Antonio	Texas
United States	AP&S Clinic, LLC	Terre Haute	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Countries where clinical trial is conducted

United States,  Croatia,  France,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival: Time From Randomization to Death From Any Cause	Survival rates over 6 years.	Up to 6 years
Secondary	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	Up to 6 years
Secondary	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	Up to 6 years
Secondary	Failure Pattern (Local/Regional Recurrence)	Percentage of patients with local/regional recurrence	Up to 6 years
Secondary	Failure Pattern (Distant Recurrence)	Percentage of patients with distant recurrence	Up to 6 years
Secondary	Quality of Life (FACT H&N)	FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)	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.
Secondary	Quality of Life (Normalcy of Diet)	Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)	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.
Secondary	Quality of Life (Speech)	Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)	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.
Secondary	Quality of Life (McMaster)	McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)	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.
Secondary	Quality of Life (FACT H&N)	FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)	Change from baseline to 1 year (1 year-pre)
Secondary	Quality of Life (Normalcy of Diet)	Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)	Change from baseline to 1 year (1 year-pre)
Secondary	Quality of Life (Speech)	Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)	Change from baseline to 1 year (1 year-pre)
Secondary	Quality of Life (McMaster)	McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)	Change from baseline to 1 year (1 year-pre)