Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx Gross total resection completed or planned No less than gross total resection No disease requiring staging surgery Prior gross total resection completed with one or more of the following risk factors: Histologically proven multiple lymph node metastases At least 1 lymph node with extracapsular extension of tumor Positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection OR Gross total resection planned within 14 days of study enrollment with anticipated need for postoperative radiotherapy for one of the following: Multiple clinically/radiologically evident lymph nodes of at least 1.5 cm Single clinically/radiologically evident lymph node of at least 3 cm Histologically proven lymph node metastases No T3, N0 glottic cancer No nasopharyngeal or paranasal sinus carcinoma No distant metastases PATIENT CHARACTERISTICS: Age: 21 and over Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: White blood cell (WBC) at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 ULN Cardiovascular: No unstable angina No myocardial infarction within the past 6 months unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty No uncontrolled arrhythmia No second or third degree heart block or other clinically significant conduction system abnormality unless pacemaker is in place Pulmonary: No severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations within the past year Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No pre-existing grade 2 or greater peripheral neurotoxicity No other prior malignancy within the past 3 years except low-risk nonmelanomatous skin cancer; carcinoma in situ (e.g., breast, cervix, or bladder); or stage T1-2, low to moderate grade prostate cancer No significant wound infection No fistula No major wound dehiscence Nutritional status adequate PRIOR CONCURRENT THERAPY: Biologic therapy: Concurrent colony-stimulating factors for neutropenic fever during study chemoradiotherapy allowed Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to head and neck Surgery: See Disease Characteristics
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Comprehensive Cancer Institute of Huntsville
- Huntsville Hospital System
- MBCCOP - Gulf Coast
- Alabama Oncology, LLC
- DCH Cancer Treatment Center
- Foundation for Cancer Research and Education
- Mount Diablo Medical Center
- City of Hope Comprehensive Cancer Center
- Saint Agnes Cancer Center
- California Cancer Center
- Sutter Health West Cancer Research Group
- Loma Linda University Medical Center
- Veterans Affairs Medical Center - Long Beach
- Jonsson Comprehensive Cancer Center, UCLA
- USC/Norris Comprehensive Cancer Center and Hospital
- CCOP - Bay Area Tumor Institute
- Huntington Cancer Center
- Robert and Beverly Lewis Family Cancer Care Center
- Radiation Oncology Center - Sacramento
- Radiation Medical Group, Inc.
- UCSF Comprehensive Cancer Center
- O'Connor Hospital
- CCOP - Santa Rosa Memorial Hospital
- David Grant Medical Center
- Memorial Hospital Cancer Center
- University of Colorado Cancer Center
- Saint Mary's Hospital and Medical Center
- Hospital of St. Raphael
- CCOP - Christiana Care Health Services
- University of Florida Health Science Center
- Florida Radiation Oncology Group
- Health First Holmes Regional Medical Center
- CCOP - Mount Sinai Medical Center
- Veterans Affairs Medical Center - Miami
- Sylvester Cancer Center, University of Miami
- Baptist Hospital of Miami
- MD Anderson Cancer Center Orlando
- Bay Medical Center
- Gulf Coast Cancer Treatment Center
- Sarasota Radiation and Medical Oncology Center
- Tallahassee Memorial Healthcare
- H. Lee Moffitt Cancer Center and Research Institute
- Emory University Hospital - Atlanta
- CCOP - Atlanta Regional
- Medical Center/John B. Amos Community Cancer Center
- Regional Radiation Oncology Center at Rome
- MBCCOP - Hawaii
- Northwest Community Hospital
- Northwestern Memorial Hospital
- CCOP - Central Illinois
- Ingalls Memorial Hospital
- Loyola University Medical Center
- Lutheran General Cancer Care Center
- Methodist Medical Center of Illinois
- St. John's Medical Center
- Bloomington Hospital
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
- Clarian Health Partners Inc.
- Regional Cancer Center
- Ball Memorial Hospital
- CCOP - Northern Indiana CR Consortium
- Wendt Regional Cancer Center of Finley Hospital
- Central Baptist Hospital
- Albert B. Chandler Medical Center, University of Kentucky
- James Graham Brown Cancer Center
- Louisville Radiation Oncology
- Merle M. Mahr Cancer Center
- Mary Bird Perkins Cancer Center
- Tulane University School of Medicine
- MBCCOP - LSU Medical Center
- CCOP - Ochsner
- Maine Medical Center
- Anne Arundel Oncology Center
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
- Greater Baltimore Medical Center and Cancer Center
- Harbor Hospital Center
- Sinai Hospital of Baltimore
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Peninsula Regional Medical Center
- Dana-Farber Cancer Institute
- Cape Cod Hospital
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- CCOP - Ann Arbor Regional
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Henry Ford Hospital
- Hurley Medical Center
- McLaren Regional Cancer Center
- CCOP - Kalamazoo
- Marquette General Hospital
- MidMichigan Medical Center - Midland
- CCOP - Beaumont
- William Beaumont Hospital
- William Beaumont Hospital - Troy
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Ellis Fischel Cancer Center - Columbia
- CCOP - Kansas City
- Mallinckrodt Institute of Radiology
- St. Louis University Health Sciences Center
- Cancer Research for the Ozarks
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- CCOP - Missouri Valley Cancer Consortium
- Methodist Hospital Cancer Center - Omaha
- Nebraska Health System
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Elliot Regional Cancer Center
- Veterans Affairs Medical Center - East Orange
- John F. Kennedy Medical Center
- Trinitas Hospital - Jersey Street Campus
- Monmouth Medical Center
- South Jersey Regional Cancer Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
- Cancer Institute of New Jersey
- Newark Beth Israel Medical Center
- Atlantic City Medical Center
- Valley Hospital
- Community Medical Center
- St. Francis Medical Center
- Associated Radiologists, P.A.
- Radiation Oncology Associates of Albuquerque
- Cancer Center of Albany Medical Center
- State University of New York Health Science Center at Brooklyn
- New York Methodist Hospital
- Roswell Park Cancer Institute
- Finger Lakes Radiation Oncology Center
- CCOP - North Shore University Hospital
- Herbert Irving Comprehensive Cancer Center
- Champlain Valley Physicians Hospital Medical Center
- Vassar Brothers Medical Center
- James P. Wilmot Cancer Center
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Riverhill Radiation Oncology
- Lineberger Comprehensive Cancer Center, UNC
- Northeast Medical Center
- East Carolina University School of Medicine
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Trinity Cancer Care Center
- Akron General Medical Center
- Akron City Hospital
- Christ Hospital
- Barrett Cancer Center
- Ireland Cancer Center
- University Hospitals of Cleveland
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Arthur G. James Cancer Hospital - Ohio State University
- CCOP - Dayton
- CCOP - Toledo Community Hospital
- St. Anthony Hospital
- University of Oklahoma Health Sciences Center
- St. John Health System
- CCOP - Oklahoma
- CCOP - Columbia River Program
- Lehigh Valley Hospital
- St. Luke's Hospital Cancer Center
- Geisinger Medical Center
- Mercy Fitzgerald Hospital
- Delaware County Memorial Hospital
- Pocono Cancer Center
- Milton S. Hershey Medical Center
- University of Pennsylvania Cancer Center
- Veterans Affairs Medical Center - Philadelphia
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- Albert Einstein Cancer Center
- University of Pittsburgh Cancer Institute
- Mercy Hospital of Pittsburgh
- Western Pennsylvania Hospital
- Reading Hospital and Medical Center
- Mercy Hospital Cancer Center - Scranton
- Wilkes Barre General Hospital
- York Cancer Center
- Roger Williams Medical Center/BUSM
- CCOP - Greenville
- CCOP - Upstate Carolina
- Rapid City Regional Hospital
- Jackson-Madison County General Hospital
- University of Tennessee Cancer Institute
- Vanderbilt-Ingram Cancer Center
- Harrington Cancer Center
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Wilford Hall Medical Center
- Joe Arrington Cancer Research and Treatment Center
- Dixie Regional Medical Center
- University of Utah Health Sciences Center
- Latter Day Saints Hospital
- Vermont Cancer Center
- Cancer Center at the University of Virginia
- RMH Regional Cancer Center
- Naval Medical Center, Portsmouth
- Bon Secours - St. Mary's Hospital
- Massey Cancer Center
- Virginia Mason Medical Center
- Deaconess Medical Center
- Yakima Valley Memorial Hospital
- Schiffler Cancer Center
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- St. Vincent Hospital
- Gundersen Lutheran Medical Foundation
- Southern Wisconsin Radiotherapy Center
- University of Wisconsin Comprehensive Cancer Center
- Marshfield Clinic
- Community Memorial Hospital
- Columbia Hospital
- St. Luke's Medical Center
- Medical College of Wisconsin
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
- All Saints Cancer Center
- Waukesha Memorial Hospital
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute
- Saint John Regional Hospital
- Newfoundland Cancer Treatment and Research Foundation
- Nova Scotia Cancer Centre
- Cancer Care Ontario-Hamilton Regional Cancer Centre
- Kingston Regional Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Ottawa Regional Cancer Centre
- Northeastern Ontario Regional Cancer Centre, Sudbury
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
- Toronto Sunnybrook Regional Cancer Centre
- Princess Margaret Hospital
- CHUS-Hopital Fleurimont
- Centre Hospitalier de l'Universite de Montreal
- McGill University
- Centre Hospitalier Universitaire de Quebec
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
Arms of the Study
Arm 1
Experimental
Surgery, chemotherapy and radiation therapy
Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.