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Reduced-Dose Intensity-Modulated Radiation Therapy with or without Cisplatin in Treating Patients with Advanced Oropharyngeal Cancer

Trial Status: Closed to Accrual and Intervention

This randomized phase II trial studies the side effects and how well modestly reduced-dose intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating patients with oropharyngeal cancer that has spread to other places in the body (advanced). Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, 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. It is not yet known whether IMRT is more effective with or without cisplatin in treating patients with oropharyngeal cancer.

Inclusion Criteria

  • STEP 1: REGISTRATION
  • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx; clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage)
  • Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations; tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site; limited neck dissections retrieving =< 4 nodes are permitted and considered as non-therapeutic nodal excisions
  • Immunohistochemical staining for p16 must be performed on tissue, and this tissue must be submitted for central review; fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin-fixed paraffin-embedded cell block material is available for p16 immunohistochemistry; FNA specimens prepared with adequate p16 testing in this manner are acceptable to submit for central review; if the p16 preparation is not adequate, additional specimens will be required to establish p16 status; centers are encouraged to contact the pathology chairs for clarification
  • Clinical stage T1-T2, N1-N2b or T3, N0-N2b (American Joint Committee on Cancer [AJCC], 7th edition [ed.]) including no distant metastases based on the following diagnostic workup: * General history and physical examination within 56 days prior to registration * Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 70 days prior to registration * One of the following combinations of imaging is required within 56 days prior to registration: ** A CT scan of the neck (with contrast) and a chest CT scan (with or without contrast) ** Or a magnetic resonance imaging (MRI) of the neck (with contrast) and a chest CT scan (with or without contrast) ** Or a CT scan of neck (with contrast) and a PET/CT of neck and chest (with or without contrast) ** Or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast) *** Note: a CT scan of neck and/or a PET/CT performed for the purpose of radiation planning may serve as both staging and planning tools
  • Patients must provide their personal smoking history prior to registration; the lifetime cumulative history cannot exceed 10 pack-years; the following formula is used to calculate the pack-years during the periods of smoking in the patient’s life; the cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history * Number of pack-years = (frequency of smoking [number of cigarettes per day] x duration of cigarette smoking [years])/20 * Note: twenty cigarettes is considered equivalent to one pack; the effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined; cigar and pipe tobacco consumption is therefore not included in calculating the lifetime pack-years; marijuana consumption is likewise not considered in this calculation; there is no clear scientific evidence regarding the role of chewing tobacco-containing products in this disease; investigators are discouraged from enrolling patients with a history of very sustained use (such as several years or more) of non-cigarette tobacco products alone
  • Zubrod performance status of 0-1 within 56 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3, within 14 days prior to registration
  • Platelets >= 100,000 cells/mm^3, within 14 days prior to registration
  • Hemoglobin >= 8.0 g/dl; Note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 8.0 g/dl is acceptable; within 14 days prior to registration
  • Serum creatinine =< 1.5 mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula, within 14 days prior to registration
  • Bilirubin =< 2 mg/dl, within 14 days prior to registration
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x the upper limit of normal, within 14 days prior to registration
  • Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
  • Patients who are human immunodeficiency virus (HIV) positive but have no prior acquired immune deficiency syndrome (AIDS)-defining illness and have cluster of differentiation (CD)4 cells of at least 350/mm^3 are eligible; HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions; patients must not be seropositive for hepatitis B (hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or seropositive for hepatitis C (anti-hepatitis C antibody positive); however, patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
  • The patient must provide study-specific informed consent prior to study entry, including consent for mandatory submission of tissue for required, central p16 review
  • Patients who speak English (or read one of the languages for which a translation is available must consent to complete the mandatory dysphagia-related patient reported instrument (MDADI); if the patient cannot understand spoken English and reads only languages not available in the MDADI translations, the patient can still participate in the trial, as this has been factored into the trial statistics; for all other patients, the MDADI is mandatory as it is included in the primary endpoint to be studied
  • STEP 2: RANDOMIZATION
  • p16 positive by immunohistochemistry (defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells, confirmed by central pathology review)

Exclusion Criteria

  • STEP 1 (REGISTRATION)
  • Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas
  • Carcinoma of the neck of unknown primary site origin (even if p16 positive)
  • Radiographically matted nodes, defined as 3 abutting nodes with loss of the intervening fat plane
  • Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle
  • Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
  • Gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease; in other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed
  • Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
  • Pregnancy
  • Prior allergic reaction to cisplatin

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Sharon A. Spencer
Phone: 205-934-0309

Arizona

Gilbert
Banner MD Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Gary V. Walker
Phone: 602-747-9738
Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL
Contact: Sun K Yi
Phone: 520-626-9008

California

Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
Burlingame
Mills-Peninsula Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Nayana Lalit Vora
Phone: 800-826-4673
Greenbrae
Marin General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Lloyd T. Miyawaki
Phone: 415-925-7325
La Jolla
UC San Diego Moores Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Loren K. Mell
Phone: 858-822-5354
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Michael Raymond Girvigian
Phone: 626-564-3455
Modesto
Memorial Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
Oakland
Kaiser Permanente Oakland-Broadway
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Parima Daroui
Phone: 877-827-8839
Palo Alto
Palo Alto Medical Foundation Health Care
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL
Contact: Quynh-Thu Xuan Le
Phone: 650-498-7061
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
Rohnert Park
Rohnert Park Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
The Permanente Medical Group-Roseville Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
Sacramento
South Sacramento Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
Sutter Medical Center Sacramento
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Shyam S. D. Rao
Phone: 916-734-3089
Saint Helena
Saint Helena Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Stephen J.M. Banks
Phone: 707-967-3698
San Diego
Naval Medical Center -San Diego
Status: CLOSED_TO_ACCRUAL
Contact: Harvey Bernard Wilds
Phone: 619-532-8712
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Contact: Sue Sun Yom
Phone: 877-827-3222
San Jose
Stanford Cancer Center South Bay
Status: CLOSED_TO_ACCRUAL
Contact: Quynh-Thu Xuan Le
Phone: 650-498-7061
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
South Pasadena
City of Hope South Pasadena
Status: CLOSED_TO_ACCRUAL
Contact: Nayana Lalit Vora
Phone: 800-826-4673
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Shyam S. D. Rao
Phone: 916-734-3089
Walnut Creek
John Muir Medical Center-Walnut Creek
Status: CLOSED_TO_ACCRUAL
Contact: Marjaneh Moini
Phone: 925-674-2580

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Sana Dole Karam
Phone: 720-848-0650
Boulder
Rocky Mountain Cancer Centers-Boulder
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663
Colorado Springs
Penrose-Saint Francis Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Englewood
Swedish Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663
Fort Collins
Poudre Valley Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Sana Dole Karam
Phone: 720-848-0650
Greeley
North Colorado Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663
Parker
Parker Adventist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 800-998-2119

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Zain A. Husain
Phone: 203-785-5702

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Gregory Andrew Masters
Phone: 302-733-6227
Rehoboth Beach
Beebe Health Campus
Status: CLOSED_TO_ACCRUAL
Contact: Gregory Andrew Masters
Phone: 302-733-6227

Florida

Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Srinath Sundararaman
Phone: 954-265-2234
Miami
Miami Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Andre A. Abitbol
Phone: 800-599-2456
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Nagy Elsayyad
Phone: 305-243-2647
Pembroke Pines
Memorial Hospital West
Status: CLOSED_TO_ACCRUAL
Contact: Srinath Sundararaman
Phone: 954-265-2234
Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Jimmy J. Caudell
Phone: 800-456-7121
Weston
Cleveland Clinic-Weston
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 866-223-8100

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jonathan Jay Beitler
Phone: 404-778-1868
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Jonathan Jay Beitler
Phone: 404-778-1868
Emory University Hospital Midtown
Status: CLOSED_TO_ACCRUAL
Contact: Jonathan Jay Beitler
Phone: 404-778-1868
Grady Health System
Status: CLOSED_TO_ACCRUAL
Contact: Jonathan Jay Beitler
Phone: 404-778-1868
Piedmont Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Adam Wayne Nowlan
Phone: 404-425-7943
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Terry Mckenzie
Phone: 912-819-5704

Hawaii

Honolulu
Queen's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Kenneth N.M. Sumida
Phone: 808-524-6115
The Cancer Center of Hawaii-Liliha
Status: CLOSED_TO_ACCRUAL
Contact: Kenneth N.M. Sumida
Phone: 808-524-6115

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-4673

Illinois

Chicago
John H Stroger Jr Hospital of Cook County
Status: CLOSED_TO_ACCRUAL
Contact: Thomas E. Lad
Phone: 312-864-6000
Northwestern University
Status: CLOSED_TO_ACCRUAL
Contact: Bharat B. Mittal
Phone: 312-695-1301
Decatur
Decatur Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-876-4740
Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Bruce E. Brockstein
Phone: 847-570-2109
Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Bruce E. Brockstein
Phone: 847-570-2109
Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Bruce E. Brockstein
Phone: 847-570-2109
Maywood
Loyola University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mehee Choi
Phone: 708-226-4357

Indiana

Fort Wayne
Parkview Hospital Randallia
Status: CLOSED_TO_ACCRUAL
Contact: Brian K. Chang
Phone: 260-373-8888
Radiation Oncology Associates PC
Status: CLOSED_TO_ACCRUAL
Contact: Brian K. Chang
Phone: 260-373-8888
South Bend
Memorial Hospital of South Bend
Status: CLOSED_TO_ACCRUAL
Contact: David Alan Hornback
Phone: 800-284-7370

Kansas

Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
Lawrence
Lawrence Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Shaker R. Dakhil
Phone: 316-268-5374
Olathe
Olathe Health Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
Overland Park
University of Kansas Cancer Center-Overland Park
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
Wichita
Ascension Via Christi Hospitals Wichita
Status: CLOSED_TO_ACCRUAL
Contact: Shaker R. Dakhil
Phone: 316-268-5374

Kentucky

Louisville
Jewish Hospital Medical Center Northeast
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
The James Graham Brown Cancer Center at University of Louisville
Status: CLOSED_TO_ACCRUAL
Contact: Neal E. Dunlap
Phone: 866-530-5516

Maryland

Baltimore
Greater Baltimore Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Geoffrey Alexander Neuner
Phone: 443-849-3706

Massachusetts

Boston
Boston Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Minh Tam Truong
Phone: 617-638-8265
Burlington
Lahey Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: William Patrick O'Meara
Phone: 978-788-7084

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-4673
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Avraham Eisbruch
Phone: 800-865-1125
Brownstown
Henry Ford Cancer Institute-Downriver
Status: CLOSED_TO_ACCRUAL
Contact: Eleanor M. Walker
Phone: 313-916-1784
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: CLOSED_TO_ACCRUAL
Contact: Eleanor M. Walker
Phone: 313-916-1784
Detroit
Henry Ford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Eleanor M. Walker
Phone: 313-916-1784
Grand Rapids
Mercy Health Saint Mary's
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Livonia
Saint Mary Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-4673
Muskegon
Mercy Health Mercy Campus
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Eleanor M. Walker
Phone: 313-916-1784

Minnesota

Coon Rapids
Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Saint Cloud
Coborn Cancer Center at Saint Cloud Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Donald James Jurgens
Phone: 877-229-4907
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
United Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Shakopee
Saint Francis Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517

Missouri

Creve Coeur
Siteman Cancer Center at West County Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Wade L. Thorstad
Phone: 800-600-3606
Kansas City
North Kansas City Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
The University of Kansas Cancer Center-South
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
University of Kansas Cancer Center - North
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
Rolla
Delbert Day Cancer Institute at PCRMC
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 800-821-7532
Saint Louis
Mercy Hospital Saint Louis
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 800-821-7532
Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Wade L. Thorstad
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Wade L. Thorstad
Phone: 800-600-3606
Springfield
CoxHealth South Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 800-821-7532
Mercy Hospital Springfield
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 800-821-7532

Montana

Billings
Billings Clinic Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin T. Marchello
Phone: 800-648-6274
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin T. Marchello
Phone: 800-648-6274
Missoula
Community Medical Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin T. Marchello
Phone: 800-648-6274

Nebraska

Grand Island
CHI Health Saint Francis
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Omaha
Alegent Health Bergan Mercy Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Alegent Health Lakeside Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Nebraska Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Tien-Shew William Huang
Phone: 402-354-5144
University of Nebraska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Weining Zhen
Phone: 402-559-8555

Nevada

Las Vegas
Radiation Oncology Centers of Nevada Central
Status: CLOSED_TO_ACCRUAL
Contact: John Allan Ellerton
Phone: 702-384-0013
Reno
Renown Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: John Allan Ellerton
Phone: 702-384-0013
Saint Mary's Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: John Allan Ellerton
Phone: 412-339-5294

New Hampshire

Dover
Wentworth-Douglass Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Arul Mahadevan
Phone: 603-740-2150
Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alan Charles Hartford
Phone: 800-639-6918

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: CLOSED_TO_ACCRUAL
Contact: Chiaojung Jillian Tsai
Phone: 212-639-7202
Livingston
Saint Barnabas Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Miguel A. Conde
Phone: 973-322-2470
Mount Holly
Virtua Memorial
Status: CLOSED_TO_ACCRUAL
Contact: Lemuel S. Ariaratnam
Phone: 609-914-6762
Voorhees
Virtua Voorhees
Status: CLOSED_TO_ACCRUAL
Contact: Lemuel S. Ariaratnam
Phone: 609-914-6762

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Gregory N. Gan
Phone: 505-925-0366

New York

Commack
Memorial Sloan Kettering Commack
Status: CLOSED_TO_ACCRUAL
Contact: Chiaojung Jillian Tsai
Phone: 212-639-7202
New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Chiaojung Jillian Tsai
Phone: 212-639-7202
Uniondale
Memorial Sloan Kettering Nassau
Status: CLOSED_TO_ACCRUAL
Contact: Chiaojung Jillian Tsai
Phone: 212-639-7202
West Harrison
Memorial Sloan Kettering Westchester
Status: CLOSED_TO_ACCRUAL
Contact: Chiaojung Jillian Tsai
Phone: 212-639-7202
White Plains
Dickstein Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey M. Vainshtein
Phone: 914-681-2290

North Carolina

Asheville
Mission Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Christopher H. Chay
Phone: 800-506-2550
Kinston
Vidant Oncology-Kinston
Status: CLOSED_TO_ACCRUAL
Contact: Peter Robins Watson
Phone: 252-559-2200
Supply
NHRMC Radiation Oncology - Supply
Status: CLOSED_TO_ACCRUAL
Contact: Michael A. Papagikos
Phone: 910-251-1839
Wilmington
NHRMC Radiation Oncology - 16th Street
Status: CLOSED_TO_ACCRUAL
Contact: Michael A. Papagikos
Phone: 910-251-1839

Ohio

Beachwood
UHHS-Chagrin Highlands Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 800-641-2422
Chardon
Geauga Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 800-641-2422
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Kevin Patrick Redmond
Phone: 513-558-4553
Cleveland
Case Western Reserve University
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 800-641-2422
Cleveland Clinic Cancer Center / Fairview Hospital
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 866-223-8100
Cleveland Clinic Foundation
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 866-223-8100
Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Maura Lianne Gillison
Phone: 800-293-5066
Elyria
Mercy Cancer Center-Elyria
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 800-641-2422
Independence
Cleveland Clinic Cancer Center Independence
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 866-223-8100
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 866-223-8100
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 800-641-2422
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 800-641-2422
Parma
University Hospitals Parma Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 800-641-2422
Sandusky
North Coast Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 866-223-8100
UH Seidman Cancer Center at Firelands Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 800-641-2422
Strongsville
Cleveland Clinic Cancer Center Strongsville
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 866-223-8100
Sylvania
ProMedica Flower Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey H Muler
Phone: 419-824-1842
West Chester
University Pointe
Status: CLOSED_TO_ACCRUAL
Contact: Kevin Patrick Redmond
Phone: 513-558-4553
Westlake
UHHS-Westlake Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 800-641-2422
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 866-223-8100

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: CLOSED_TO_ACCRUAL
Contact: Terence S. Herman
Phone: 405-271-8777
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Terence S. Herman
Phone: 405-271-8777

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Andrew Y. Kee
Phone: 800-220-4937

Pennsylvania

Abington
Abington Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Wayne H. Pinover
Phone: 215-481-2402
Beaver
UPMC-Heritage Valley Health System Beaver
Status: CLOSED_TO_ACCRUAL
Contact: David Anthony Clump
Phone: 412-621-2334
Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Status: CLOSED_TO_ACCRUAL
Contact: David Anthony Clump
Phone: 412-621-2334
Hershey
Penn State Milton S Hershey Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Salah M. Almokadem
Phone: 717-531-3779
Johnstown
UPMC-Johnstown / John P. Murtha Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: David Anthony Clump
Phone: 412-621-2334
McKeesport
UPMC Cancer Center at UPMC McKeesport
Status: CLOSED_TO_ACCRUAL
Contact: David Anthony Clump
Phone: 412-621-2334
Moon Township
UPMC-Coraopolis / Heritage Valley Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: David Anthony Clump
Phone: 412-621-2334
Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Thomas James Galloway
Phone: 215-728-4790
Pittsburgh
UPMC-Passavant Hospital
Status: CLOSED_TO_ACCRUAL
Contact: David Anthony Clump
Phone: 412-621-2334
UPMC-Saint Margaret
Status: CLOSED_TO_ACCRUAL
Contact: David Anthony Clump
Phone: 412-621-2334
UPMC-Shadyside Hospital
Status: CLOSED_TO_ACCRUAL
Contact: David Anthony Clump
Phone: 412-621-2334
Seneca
UPMC Cancer Center at UPMC Northwest
Status: CLOSED_TO_ACCRUAL
Contact: David Anthony Clump
Phone: 412-621-2334
Uniontown
UPMC Uniontown Hospital Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: David Anthony Clump
Phone: 412-621-2334
Washington
UPMC Washington Hospital Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: David Anthony Clump
Phone: 412-621-2334
West Reading
Reading Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Terrence Paul Cescon
Phone: 610-988-9323

South Carolina

Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL
Contact: Anand Kumar Sharma
Phone: 843-792-9321
Greenville
Prisma Health Cancer Institute - Eastside
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Prisma Health Cancer Institute - Faris
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Greer
Prisma Health Cancer Institute - Greer
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Seneca
Prisma Health Cancer Institute - Seneca
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Spartanburg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Amarinthia (Amy) Curtis
Phone: 800-486-5941

Tennessee

Knoxville
Tennessee Cancer Specialists-Dowell Springs
Status: CLOSED_TO_ACCRUAL
Contact: J. Ben Wilkinson
Phone: 865-244-3209

Texas

Conroe
MD Anderson in The Woodlands
Status: CLOSED_TO_ACCRUAL
Contact: Adam S. Garden
Phone: 713-792-3245
Galveston
University of Texas Medical Branch
Status: CLOSED_TO_ACCRUAL
Contact: Maurice Willis
Phone: 409-772-1950
Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Adam S. Garden
Phone: 713-792-3245
MD Anderson West Houston
Status: CLOSED_TO_ACCRUAL
Contact: Adam S. Garden
Phone: 713-792-3245
League City
MD Anderson League City
Status: CLOSED_TO_ACCRUAL
Contact: Adam S. Garden
Phone: 713-792-3245
UTMB Cancer Center at Victory Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Maurice Willis
Phone: 409-772-1950

Utah

Murray
Intermountain Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Vilija N. Avizonis
Phone: 801-507-3950
Ogden
McKay-Dee Hospital Center
Status: CLOSED_TO_ACCRUAL
Contact: Vilija N. Avizonis
Phone: 801-507-3950
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL
Contact: Ying Jia Hitchcock
Phone: 801-581-4477
Utah Cancer Specialists-Salt Lake City
Status: CLOSED_TO_ACCRUAL
Contact: Vilija N. Avizonis
Phone: 801-507-3950

Vermont

Saint Johnsbury
Norris Cotton Cancer Center-North
Status: CLOSED_TO_ACCRUAL
Contact: Alan Charles Hartford
Phone: 800-639-6918

Virginia

Charlottesville
University of Virginia Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Read
Phone: 434-243-6322
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Shiyu Song
Phone: 804-628-1939

Washington

Gig Harbor
Tacoma / Valley Radiation Oncology Centers-Gig Harbor
Status: CLOSED_TO_ACCRUAL
Contact: John A. Keech
Phone: 253-403-2394
Seattle
Virginia Mason Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: John A. Keech
Phone: 253-403-2394
Tacoma
MultiCare Tacoma General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: John A. Keech
Phone: 253-403-2394
Tacoma / Valley Radiation Oncology Centers-Jackson Hall
Status: CLOSED_TO_ACCRUAL
Contact: John A. Keech
Phone: 253-403-2394
Tacoma / Valley Radiation Oncology Centers-Saint Joe's
Status: CLOSED_TO_ACCRUAL
Contact: John A. Keech
Phone: 253-403-2394
Vancouver
Legacy Salmon Creek Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Andrew Y. Kee
Phone: 800-220-4937

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: CLOSED_TO_ACCRUAL
Contact: Matthew L. Ryan
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: CLOSED_TO_ACCRUAL
Contact: Matthew L. Ryan
Phone: 920-433-8889
Johnson Creek
UW Cancer Center Johnson Creek
Status: CLOSED_TO_ACCRUAL
Contact: Paul Maurice Harari
Phone: 877-405-6866
La Crosse
Gundersen Lutheran Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Collin D. Driscoll
Phone: 608-775-2385
Madison
University of Wisconsin Hospital and Clinics
Status: CLOSED_TO_ACCRUAL
Contact: Paul Maurice Harari
Phone: 877-405-6866
Menomonee Falls
Froedtert Menomonee Falls Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jared Rex Robbins
Phone: 414-805-4380
Milwaukee
Medical College of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Jared Rex Robbins
Phone: 414-805-4380
Racine
Ascension All Saints Hospital
Status: CLOSED_TO_ACCRUAL
Contact: James H. Taylor
Phone: 262-785-2273
Sheboygan
HSHS Saint Nicholas Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Matthew L. Ryan
Phone: 920-433-8889
West Bend
Froedtert West Bend Hospital / Kraemer Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Jared Rex Robbins
Phone: 414-805-4380
Wisconsin Rapids
Aspirus UW Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Paul Maurice Harari
Phone: 877-405-6866

Alberta

Calgary
Tom Baker Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Robyn Nathan Banerjee
Phone: 403-521-3433
Edmonton
Cross Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Robyn Nathan Banerjee
Phone: 403-521-3433

British Columbia

Victoria
BCCA-Vancouver Island Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Hosam (Sam) A. Kader
Phone: 604-877-6010

Ontario

Hamilton
Juravinski Cancer Centre at Hamilton Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Do-Hoon Kim
Phone: 905-387-9495
Kingston
Kingston Health Sciences Centre
Status: CLOSED_TO_ACCRUAL
Contact: Khaled Osman Zaza
Phone: 613-544-2630
Toronto
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Status: CLOSED_TO_ACCRUAL
Contact: Justin Lee
Phone: 416-480-5000
University Health Network-Princess Margaret Hospital
Status: CLOSED_TO_ACCRUAL
Contact: John Nicholas Waldron
Phone: 416-946-4501
Windsor
Windsor Regional Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Ming Pan
Phone: 519-253-5253

Quebec

Montreal
CHUM - Hopital Notre-Dame
Status: CLOSED_TO_ACCRUAL
Contact: Louise Lambert
Phone: 514-890-8000ext23611
Jewish General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Khalil Sultanem
Phone: 514-340-8222ext8248
McGill University Department of Oncology
Status: CLOSED_TO_ACCRUAL
Contact: George Shenouda
Phone: 514-934-1934ext42953

Saskatchewan

Regina
Allan Blair Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Derek Suderman
Phone: 306-766-2213
Saskatoon
Saskatoon Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Ali A. H. H. El-Gayed
Phone: 306-655-2914

Ireland

Dublin
Saint Lukes Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Sinead M. Brennan
Phone: 353 1 4065000

Saudi Arabia

Riyadh
King Faisal Specialist Hospital and Research Centre
Status: CLOSED_TO_ACCRUAL
Contact: Nasser Al-Rajhi
Phone: 011-966-1-464-7272 ext 38005

PRIMARY OBJECTIVES:

I. To select the arm(s) achieving a 2-year progression-free survival rate of >= 85% without unacceptable swallowing toxicity at 1 year.

SECONDARY OBJECTIVES:

I. To determine patterns of failure (locoregional relapse versus distant) and survival (overall and progression-free) at 6 months and 2 years.

II. To determine acute toxicity profiles at the end of radiation therapy and at 1 and 6 months.

III. To determine late toxicity profiles at 1 and 2 years.

IV. To determine patient-reported swallowing outcomes at 6 months and 1 and 2 years.

V. To determine the predictive value of 12-14 week, post-treatment fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) for locoregional control and progression free survival (PFS) at 2 years.

VI. To determine the predictive value of blood and tissue biomarkers for disease outcomes at 2 years.

VII. To determine swallowing recovery per videofluoroscopy imaging at 2 years.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo IMRT once daily (QD) five days a week for 6 weeks to a total dose of 60 Gy and receive cisplatin intravenously (IV) over 30-60 minutes weekly during radiation therapy for 6 doses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo IMRT five days a week for 5 weeks to a total dose of 60 Gy in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Sue Sun Yom

  • Primary ID NRG-HN002
  • Secondary IDs NCI-2014-01279
  • Clinicaltrials.gov ID NCT02254278