Isotretinoin, Interferon Alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00054561
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy such as isotretinoin use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Vitamin E may be able to decrease side effects caused by isotretinoin. It is not yet known whether combining isotretinoin and interferon alfa with vitamin E is more effective than observation in preventing recurrence of head and neck cancer after surgery and/or radiation therapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of isotretinoin and interferon alfa combined with vitamin E with that of observation in treating patients who have undergone surgery and/or radiation therapy for stage III or stage IV head and neck cancer.
- Detailed Description
OBJECTIVES:
* Determine the efficacy of adjuvant isotretinoin, interferon alfa, and vitamin E, in terms of incidence of primary disease recurrence and secondary primary tumor development, in patients with stage III or IV squamous cell carcinoma of the head and neck previously treated with definitive surgical excision and/or postoperative radiotherapy.
* Determine the qualitative and quantitative toxicity of this regimen in these patients.
* Compare the overall and disease-free survival of patients treated with this regimen vs those who undergo observation only.
* Determine whether alterations of p53 gene, retinoic acid receptors, retinoid-regulated gene, and interferon-responsive genes are associated with clinical outcome in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to T stage (T1 or T2 vs T3 or T4), N stage (N0 or N1 vs N2 or N3), prior therapy (complete tumor resection vs resection and radiotherapy/chemoradiotherapy vs radiotherapy or chemoradiotherapy alone), and prior chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral isotretinoin once daily, interferon alfa subcutaneously 3 times weekly, and oral vitamin E 3 times daily. Treatment repeats every month for 12 courses (1 year) in the absence of disease recurrence or unacceptable toxicity.
* Arm II: Patients undergo observation only for 1 year. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 376 patients (188 per treatment arm) will be accrued for this study within 3.75 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (89)
Winship Cancer Institute of Emory University
πΊπΈAtlanta, Georgia, United States
Veterans Affairs Medical Center - Lakeside Chicago
πΊπΈChicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
πΊπΈChicago, Illinois, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
πΊπΈCleveland, Ohio, United States
Veterans Affairs Medical Center - Miami
πΊπΈMiami, Florida, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
πΊπΈIndianapolis, Indiana, United States
University of Minnesota Cancer Center
πΊπΈMinneapolis, Minnesota, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
πΊπΈScottsdale, Arizona, United States
Veterans Affairs Medical Center - Palo Alto
πΊπΈPalo Alto, California, United States
CCOP - Christiana Care Health Services
πΊπΈNewark, Delaware, United States
City of Hope Comprehensive Cancer Center
πΊπΈDuarte, California, United States
Indiana University Cancer Center
πΊπΈIndianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project
πΊπΈCedar Rapids, Iowa, United States
CCOP - Carle Cancer Center
πΊπΈUrbana, Illinois, United States
CCOP - Northern Indiana CR Consortium
πΊπΈSouth Bend, Indiana, United States
MBCCOP - Howard University Cancer Center
πΊπΈWashington, District of Columbia, United States
Burgess Health Center
πΊπΈOnawa, Iowa, United States
Stanford Cancer Center at Stanford University Medical Center
πΊπΈStanford, California, United States
CCOP - Central Illinois
πΊπΈDecatur, Illinois, United States
CCOP - Duluth
πΊπΈDuluth, Minnesota, United States
CCOP - Kalamazoo
πΊπΈKalamazoo, Michigan, United States
CCOP - Wichita
πΊπΈWichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
πΊπΈWichita, Kansas, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
πΊπΈLebanon, New Hampshire, United States
Hahnemann University Hospital
πΊπΈPhiladelphia, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania
πΊπΈPhiladelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Minneapolis
πΊπΈMinneapolis, Minnesota, United States
CCOP - Illinois Oncology Research Association
πΊπΈPeoria, Illinois, United States
Midlands Cancer Center at Midlands Community Hospital
πΊπΈPapillion, Nebraska, United States
Cleveland Clinic Taussig Cancer Center
πΊπΈCleveland, Ohio, United States
CCOP - Southern Nevada Cancer Research Foundation
πΊπΈLas Vegas, Nevada, United States
MBCCOP - San Juan
π΅π·San Juan, Puerto Rico
CCOP - Northern New Jersey
πΊπΈHackensack, New Jersey, United States
CCOP - MainLine Health
πΊπΈWynnewood, Pennsylvania, United States
Veterans Affairs Medical Center - Brooklyn
πΊπΈBrooklyn, New York, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
πΊπΈPittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh
πΊπΈPittsburgh, Pennsylvania, United States
CCOP - Toledo Community Hospital
πΊπΈToledo, Ohio, United States
Pretoria Academic Hospital
πΏπ¦Pretoria, South Africa
CCOP - Columbus
πΊπΈColumbus, Ohio, United States
Westmead Breast Centre at NSW Breast Cancer Institute
π¦πΊWestmead, New South Wales, Australia
CCOP - Merit Care Hospital
πΊπΈFargo, North Dakota, United States
Veterans Affairs Medical Center - New York
πΊπΈNew York, New York, United States
CCOP - Sioux Community Cancer Consortium
πΊπΈSioux Falls, South Dakota, United States
San Juan City Hospital
π΅π·San Juan, Puerto Rico
CCOP - Scott and White Hospital
πΊπΈTemple, Texas, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
πΊπΈGreen Bay, Wisconsin, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
πΊπΈNashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
πΊπΈNashville, Tennessee, United States
University of Alabama at Birmingham Comprehensive Cancer Center
πΊπΈBirmingham, Alabama, United States
Mayo Clinic Cancer Center
πΊπΈRochester, Minnesota, United States
Instituto de Enfermedades Neoplasicas
π΅πͺLima, Peru
Fox Chase Cancer Center
πΊπΈPhiladelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Omaha
πΊπΈOmaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
πΊπΈOmaha, Nebraska, United States
Medical College of Wisconsin Cancer Center
πΊπΈMilwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
πΊπΈMilwaukee, Wisconsin, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
πΊπΈNew York, New York, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
πΊπΈHershey, Pennsylvania, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
πΊπΈDecatur, Georgia, United States
Decatur Memorial Hospital Cancer Care Institute
πΊπΈDecatur, Illinois, United States
CCOP - Evanston
πΊπΈEvanston, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
πΊπΈBaltimore, Maryland, United States
Tufts - New England Medical Center
πΊπΈBoston, Massachusetts, United States
CCOP - Metro-Minnesota
πΊπΈSaint Louis Park, Minnesota, United States
Veterans Affairs Medical Center - East Orange
πΊπΈEast Orange, New Jersey, United States
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
πΊπΈNew Brunswick, New Jersey, United States
CCOP - Oklahoma
πΊπΈTulsa, Oklahoma, United States
CCOP - Geisinger Clinic and Medical Center
πΊπΈDanville, Pennsylvania, United States
CCOP - Marshfield Clinic Research Foundation
πΊπΈMarshfield, Wisconsin, United States
Westmead Hospital
π¦πΊWestmead, New South Wales, Australia
Veterans Affairs Medical Center - San Juan
π΅π·San Juan, Puerto Rico
Beth Israel Deaconess Medical Center
πΊπΈBoston, Massachusetts, United States
West Michigan Cancer Center
πΊπΈKalamazoo, Michigan, United States
H. Lee Moffitt Cancer Center and Research Institute
πΊπΈTampa, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley)
πΊπΈTampa, Florida, United States
CCOP - Michigan Cancer Research Consortium
πΊπΈAnn Arbor, Michigan, United States
Veterans Affairs Medical Center - Gainesville
πΊπΈGainesville, Florida, United States
CCOP - Ochsner
πΊπΈNew Orleans, Louisiana, United States
MBCCOP - LSU Health Sciences Center
πΊπΈNew Orleans, Louisiana, United States
CCOP - Iowa Oncology Research Association
πΊπΈDes Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
πΊπΈDes Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
πΊπΈDes Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
πΊπΈDes Moines, Iowa, United States
MBCCOP - University of New Mexico HSC
πΊπΈAlbuquerque, New Mexico, United States
Albert Einstein Clinical Cancer Center
πΊπΈBronx, New York, United States
MBCCOP-Our Lady of Mercy Cancer Center
πΊπΈBronx, New York, United States
Veterans Affairs Medical Center - Madison
πΊπΈMadison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
πΊπΈMadison, Wisconsin, United States