Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery
Start Date
3/12/2019
Completion Date
3/31/2029
Summary
This randomized phase II trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer that can be removed by surgery. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation.
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the structure preservation rate for patients with locally advanced resectable nasal and paranasal sinus squamous cell carcinoma (NPNSCC) with or without neoadjuvant therapy; all patients will undergo surgical resection and postoperative standard care. II. Evaluate overall survival (OS) for patients with locally advanced resectable NPNSCC with or without neoadjuvant therapy followed by surgical resection and postoperative standard care. SECONDARY OBJECTIVES: I. Evaluate progression-free survival (PFS) for this patient population. II. Examine the rate of structure preservation for the orbit (freedom from orbital exenteration). III. Evaluate site reported p16 data and correlate with outcome. IV. Determine the accuracy of baseline/post-chemotherapy magnetic resonance imaging (MRI) and fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG PET/CT)-based prediction of orbit and skull base preservation. V. Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of 2-year overall survival. TERTIARY OBJECTIVES: I. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events \[both clinical and hematologic\] and dose modifications). II. To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms. III. To examine quitting behaviors and behavioral counseling/support and cessation medication utilization. IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo standard of care surgery. Beginning 4-6 weeks after surgery, patients undergo image guided intensity modulated radiation therapy (IMRT) once daily (QD) for 5 fractions per week for 30 fractions. Patients with positive margins/positive extracapsular spread (ECS) in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin intravenously (IV) over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Patients who are ineligible to receive cisplatin receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery no later than 6 weeks following the last dose of chemotherapy. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months if \< 2 years from study entry and then every 6 months if 2-5 years from study entry.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Carboplatin
Cisplatin
Docetaxel
Image Guided Radiation Therapy
Intensity-Modulated Radiation Therapy
Laboratory Biomarker Analysis
Questionnaire Administration
Therapeutic Conventional Surgery
Conditions
Locations
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona 85704
United States
Banner University Medical Center - Tucson
Tucson, Arizona 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
United States
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
United States
VA Palo Alto Health Care System
Palo Alto, California 94304
United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut 06510
United States
Yale University
New Haven, Connecticut 06520
United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
United States
Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Emory Proton Therapy Center
Atlanta, Georgia 30308
United States
Emory University Hospital Midtown
Atlanta, Georgia 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United States
Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
United States
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United States
Rush - Copley Medical Center
Aurora, Illinois 60504
United States
Northwestern University
Chicago, Illinois 60611
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
Carle on Vermilion
Danville, Illinois 61832
United States
Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864
United States
Carle Cancer Center
Urbana, Illinois 61801
United States
The Carle Foundation Hospital
Urbana, Illinois 61801
United States
Saint Anthony Regional Hospital
Carroll, Iowa 51401
United States
Iowa Methodist Medical Center
Des Moines, Iowa 50309
United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
United States
Broadlawns Medical Center
Des Moines, Iowa 50314
United States
Iowa Lutheran Hospital
Des Moines, Iowa 50316
United States
Methodist West Hospital
West Des Moines, Iowa 50266-7700
United States
Central Care Cancer Center - Garden City
Garden City, Kansas 67846
United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
United States
University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
Lawrence Memorial Hospital
Lawrence, Kansas 66044
United States
Olathe Health Cancer Center
Olathe, Kansas 66061
United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
United States
Ascension Via Christi - Pittsburg
Pittsburg, Kansas 66762
United States
Salina Regional Health Center
Salina, Kansas 67401
United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas 66606
United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan 48183
United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan 48126
United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
United States
Allegiance Health
Jackson, Michigan 49201
United States
Henry Ford Medical Center-Columbus
Novi, Michigan 48377
United States
Henry Ford Macomb Health Center - Shelby Township
Shelby, Michigan 48315
United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
United States
Freeman Health System
Joplin, Missouri 64804
United States
Mercy Hospital Joplin
Joplin, Missouri 64804
United States
University of Kansas Cancer Center - North
Kansas City, Missouri 64154
United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri 64116
United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
United States
Heartland Regional Medical Center
Saint Joseph, Missouri 64506
United States
Mercy Hospital Springfield
Springfield, Missouri 65804
United States
CoxHealth South Hospital
Springfield, Missouri 65807
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Mercy Hospital South
St Louis, Missouri 63128
United States
Siteman Cancer Center-South County
St Louis, Missouri 63129
United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
United States
Mercy Hospital Saint Louis
St Louis, Missouri 63141
United States
Billings Clinic Cancer Center
Billings, Montana 59101
United States
Bozeman Deaconess Hospital
Bozeman, Montana 59715
United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
United States
Great Falls Clinic
Great Falls, Montana 59405
United States
Kalispell Regional Medical Center
Kalispell, Montana 59901
United States
Community Medical Hospital
Missoula, Montana 59804
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United States
Northwell Health Imbert Cancer Center
Bay Shore, New York 11706
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
United States
Long Island Jewish Medical Center
New Hyde Park, New York 11040
United States
Lenox Hill Hospital
New York, New York 10021
United States
Mount Sinai Hospital
New York, New York 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
University of Rochester
Rochester, New York 14642
United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York 10461
United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York 10461
United States
Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
United States
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania 15009
United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
United States
UPMC Jameson
New Castle, Pennsylvania 16105
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
United States
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania 15301
United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
Parkland Memorial Hospital
Dallas, Texas 75235
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
United States
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United States
Inova Fairfax Hospital
Falls Church, Virginia 22042
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
United States
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin 54482
United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin 54401
United States
Diagnostic and Treatment Center
Weston, Wisconsin 54476
United States
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
United States
Welch Cancer Center
Sheridan, Wyoming 82801
United States