Phase
Condition
Carcinoma
Treatment
Laboratory Biomarker Analysis
Intensity-Modulated Radiation Therapy
Therapeutic Conventional Surgery
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
General physical condition compatible with the proposed chemotherapy and surgery
Stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection:
Stages T3 and T4a disease will be included regardless of nodal status (N0 or N1-3), provided that surgical therapy would require orbital or skull base resection
The surgical oncologist in each institution will determine the need for resection of the orbit OR base of skull at baseline for patients on both Arms A and B and following neo-adjuvant chemotherapy for patients on Arm B
Resection of skull base will be deemed necessary according to skull base bone erosion by CT or marrow involvement by MRI is noted; for any disease abutting the skull base; or for ethmoid sinus or frontal sinus involvement
Resection of orbital contents will be deemed necessary according to skull base society guidelines, based on involvement of periorbital fat documented by MRI imaging
Patients must be deemed surgically resectable by the surgical teams at each institution and must have a determination of degree of anticipated structure preservation of orbit and skull base; this needs to be determined prior to randomization
Patients may not be receiving investigational agents at time of registration, or at any time while on study and during the 4 weeks preceding enrollment
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel and/or both platinum-based chemotherapy agents are excluded; patient must be able to receive at least one of the two proposed chemotherapy regimens
Patients with evidence of distant metastases or leptomeningeal disease (LMD) are excluded
Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors
Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excluded
Patients with a history of a different malignancy are excluded, unless the disease has not progressed for >= 2 years
Absolute neutrophil count (ANC) > 1500/mm^3 =< 2 weeks prior to randomization
Hemoglobin (Hgb) > 8.0 g/dL =< 2 weeks prior to randomization
Platelet count > 100,000/mm^3 =< 2 weeks prior to randomization
Creatinine clearance of > 60 ml/min; creatinine clearance may be measured or calculated; if calculating, creatinine clearance, use the Cockroft-Gault formula =< 2 weeks prior to randomization
Total bilirubin within normal limits (must be obtained =< 2 weeks prior to randomization)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) must be within the range allowing for eligibility, must be obtained < 2 weeks prior to randomization
Alkaline phosphatase must be within the range allowing for eligibility, must be obtained < 2 weeks prior to randomization
Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated
No current peripheral neuropathy > grade 2 at time of randomization
Patients must not have any co-existing condition that would preclude full compliance with the study; no prior history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Women must not be pregnant or breast-feeding
All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
Patients must have measurable disease; MRI and/or PET/CT scans need to be performed within 2 weeks prior to registration
Study Design
Study Description
Connect with a study center
Banner University Medical Center - Tucson
Tucson, Arizona 85719
United StatesActive - Recruiting
University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
United StatesActive - Recruiting
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona 85704
United StatesActive - Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
United StatesActive - Recruiting
UC San Diego Moores Cancer Center
La Jolla, California 92093
United StatesSite Not Available
Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
United StatesActive - Recruiting
VA Palo Alto Health Care System
Palo Alto, California 94304
United StatesActive - Recruiting
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut 06510
United StatesActive - Recruiting
Yale University
New Haven, Connecticut 06520
United StatesActive - Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
United StatesSuspended
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
United StatesActive - Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United StatesActive - Recruiting
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
United StatesActive - Recruiting
Moffitt Cancer Center
Tampa, Florida 33612
United StatesActive - Recruiting
Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
United StatesActive - Recruiting
Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
United StatesActive - Recruiting
Emory Proton Therapy Center
Atlanta, Georgia 30308
United StatesActive - Recruiting
Emory University Hospital Midtown
Atlanta, Georgia 30308
United StatesActive - Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United StatesActive - Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
United StatesActive - Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
United StatesActive - Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United StatesActive - Recruiting
Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
United StatesActive - Recruiting
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686
United StatesActive - Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United StatesActive - Recruiting
Rush - Copley Medical Center
Aurora, Illinois 60504
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesActive - Recruiting
Carle on Vermilion
Danville, Illinois 61832
United StatesActive - Recruiting
Carle Physician Group-Effingham
Effingham, Illinois 62401
United StatesActive - Recruiting
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
United StatesActive - Recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
United StatesActive - Recruiting
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
United StatesActive - Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United StatesActive - Recruiting
Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864
United StatesActive - Recruiting
Carle Cancer Center
Urbana, Illinois 61801
United StatesActive - Recruiting
The Carle Foundation Hospital
Urbana, Illinois 61801
United StatesActive - Recruiting
Saint Anthony Regional Hospital
Carroll, Iowa 51401
United StatesActive - Recruiting
Broadlawns Medical Center
Des Moines, Iowa 50314
United StatesActive - Recruiting
Iowa Lutheran Hospital
Des Moines, Iowa 50316
United StatesActive - Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa 50309
United StatesActive - Recruiting
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
United StatesActive - Recruiting
Methodist West Hospital
West Des Moines, Iowa 50266-7700
United StatesActive - Recruiting
Central Care Cancer Center - Garden City
Garden City, Kansas 67846
United StatesActive - Recruiting
Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
United StatesActive - Recruiting
University of Kansas Cancer Center
Kansas City, Kansas 66160
United StatesSite Not Available
Lawrence Memorial Hospital
Lawrence, Kansas 66044
United StatesSite Not Available
Olathe Health Cancer Center
Olathe, Kansas 66061
United StatesSite Not Available
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
United StatesSite Not Available
Ascension Via Christi - Pittsburg
Pittsburg, Kansas 66762
United StatesSite Not Available
Salina Regional Health Center
Salina, Kansas 67401
United StatesSite Not Available
University of Kansas Health System Saint Francis Campus
Topeka, Kansas 66606
United StatesSite Not Available
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
United StatesSite Not Available
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
United StatesActive - Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United StatesSuspended
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan 48183
United StatesActive - Recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
United StatesActive - Recruiting
Henry Ford Medical Center-Fairlane
Dearborn, Michigan 48126
United StatesActive - Recruiting
Henry Ford Hospital
Detroit, Michigan 48202
United StatesActive - Recruiting
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
Allegiance Health
Jackson, Michigan 49201
United StatesActive - Recruiting
Henry Ford Medical Center-Columbus
Novi, Michigan 48377
United StatesActive - Recruiting
Henry Ford Macomb Health Center - Shelby Township
Shelby, Michigan 48315
United StatesActive - Recruiting
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
United StatesActive - Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United StatesActive - Recruiting
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
United StatesActive - Recruiting
Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
United StatesActive - Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
United StatesActive - Recruiting
Freeman Health System
Joplin, Missouri 64804
United StatesActive - Recruiting
Mercy Hospital Joplin
Joplin, Missouri 64804
United StatesActive - Recruiting
University of Kansas Cancer Center - North
Kansas City, Missouri 64154
United StatesSite Not Available
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri 64116
United StatesSite Not Available
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
United StatesActive - Recruiting
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
United StatesActive - Recruiting
Heartland Regional Medical Center
Saint Joseph, Missouri 64506
United StatesActive - Recruiting
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
United StatesActive - Recruiting
Mercy Hospital South
Saint Louis, Missouri 63128
United StatesActive - Recruiting
Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
United StatesActive - Recruiting
Siteman Cancer Center-South County
Saint Louis, Missouri 63129
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
United StatesActive - Recruiting
CoxHealth South Hospital
Springfield, Missouri 65807
United StatesActive - Recruiting
Mercy Hospital Springfield
Springfield, Missouri 65804
United StatesActive - Recruiting
Billings Clinic Cancer Center
Billings, Montana 59101
United StatesActive - Recruiting
Bozeman Deaconess Hospital
Bozeman, Montana 59715
United StatesActive - Recruiting
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
United StatesActive - Recruiting
Great Falls Clinic
Great Falls, Montana 59405
United StatesActive - Recruiting
Kalispell Regional Medical Center
Kalispell, Montana 59901
United StatesActive - Recruiting
Community Medical Hospital
Missoula, Montana 59804
United StatesActive - Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United StatesActive - Recruiting
Northwell Health Imbert Cancer Center
Bay Shore, New York 11706
United StatesActive - Recruiting
Montefiore Medical Center - Moses Campus
Bronx, New York 10467
United StatesActive - Recruiting
Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
United StatesActive - Recruiting
Montefiore Medical Center-Weiler Hospital
Bronx, New York 10461
United StatesActive - Recruiting
Roswell Park Cancer Institute
Buffalo, New York 14263
United StatesActive - Recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
United StatesActive - Recruiting
Long Island Jewish Medical Center
New Hyde Park, New York 11040
United StatesActive - Recruiting
Lenox Hill Hospital
New York, New York 10021
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Mount Sinai Hospital
New York, New York 10029
United StatesActive - Recruiting
University of Rochester
Rochester, New York 14642
United StatesActive - Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
United StatesActive - Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United StatesActive - Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
United StatesActive - Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
United StatesActive - Recruiting
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
United StatesActive - Recruiting
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
United StatesActive - Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania 15009
United StatesActive - Recruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
United StatesActive - Recruiting
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
United StatesActive - Recruiting
UPMC Jameson
New Castle, Pennsylvania 16105
United StatesSuspended
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
United StatesActive - Recruiting
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania 15301
United StatesActive - Recruiting
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United StatesActive - Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United StatesActive - Recruiting
Parkland Memorial Hospital
Dallas, Texas 75235
United StatesSite Not Available
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United StatesSite Not Available
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
United StatesSite Not Available
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United StatesActive - Recruiting
Inova Fairfax Hospital
Falls Church, Virginia 22042
United StatesActive - Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
United StatesActive - Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
United StatesActive - Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
United StatesActive - Recruiting
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin 54482
United StatesActive - Recruiting
Marshfield Clinic-Wausau Center
Wausau, Wisconsin 54401
United StatesSuspended
Diagnostic and Treatment Center
Weston, Wisconsin 54476
United StatesActive - Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
United StatesActive - Recruiting
Welch Cancer Center
Sheridan, Wyoming 82801
United StatesActive - Recruiting
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