A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

Who is this study for? Adult patients with HPV-positive oropharyngeal squamous cell carcinoma
Status: Recruiting
Location: See all (464) locations...
Intervention Type: Other, Drug, Biological, Radiation
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma but not neuroendocrine phenotype) 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. Simple 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

• P16-positive based on local site immunohistochemical tissue staining (defined as greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining of tumor cells). Fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification

• Note: Institutions must screen patients, whose tumors must be p16-positive by immunohistochemistry (IHC) in order to be eligible for the trial using a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process similar to the United States (U.S.) CLIA certification, such as the provincial accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in Canada, the College of American Pathologists (CAP), or an equivalent accreditation in other countries, is acceptable. The p16-positive results must be reported on the pathology report being submitted

• Clinical stage T1-2, N1, M0 (American Joint Committee on Cancer [AJCC], 8th edition [ed.]) or T3, N0-N1, M0 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:

• General history and physical examination within 56 days prior to registration;

• Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable) within 70 days prior to registration;

• One of the following imaging studies is required within 56 days prior to registration:

• FDG-PET/CT of the neck and chest (with or without contrast); FDG-PET/CT scan is strongly preferred and highly recommended to be used for eligibility OR

• Chest CT (with or without contrast)

• One of the following imaging studies is required within 28 days prior to registration:

• A diagnostic CT scan of neck (with contrast and of diagnostic quality) OR

• An magnetic resonance imaging (MRI) of the neck (with contrast and of diagnostic quality)

• Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT scan of neck performed for the purposes 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. While there are reportedly increased risks of head and neck cancer associated with sustained heavy cigar and pipe use (Wyss 2013), such sustained use of non-cigarette products is unusual and does not appear to convey added risk with synchronous cigarette smoking. 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, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, 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 14 days prior to registration

• Absolute neutrophil count >= 1,500/mcL (within 14 days prior to registration)

• Platelets >= 100,000/mcL (within 14 days prior to registration)

• Hemoglobin >= 8.0 g/dL (within 14 days prior to registration) (Note: use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable)

• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 14 days prior to registration)

• Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN (within 14 days prior to registration)

• Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) (within 14 days prior to registration)

• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

• Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)

• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment for the hepatitis, they are eligible if they have an undetectable HCV viral load.

• Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy

• For women of childbearing potential (WOCBP), negative serum or urine pregnancy test within 24 hours prior to registration

• Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL

• Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must be willing to use an adequate method of contraception during and after treatment

• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

• Only English, Spanish, or French speaking patients are eligible to participate as these are the only languages for which the mandatory dysphagia-related patient reported instrument (MDADI) is available

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
Recruiting
Birmingham
Arizona
Banner MD Anderson Cancer Center
Recruiting
Gilbert
Banner University Medical Center - Tucson
Recruiting
Tucson
University of Arizona Cancer Center-North Campus
Recruiting
Tucson
California
Kaiser Permanente-Deer Valley Medical Center
Recruiting
Antioch
Sutter Auburn Faith Hospital
Recruiting
Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Recruiting
Auburn
Tower Cancer Research Foundation
Recruiting
Beverly Hills
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Recruiting
Cameron Park
City of Hope Comprehensive Cancer Center
Recruiting
Duarte
Kaiser Permanente Dublin
Recruiting
Dublin
UC San Diego Health System - Encinitas
Recruiting
Encinitas
Kaiser Permanente-Fremont
Recruiting
Fremont
Fresno Cancer Center
Recruiting
Fresno
Kaiser Permanente-Fresno
Recruiting
Fresno
UC San Diego Moores Cancer Center
Recruiting
La Jolla
City of Hope Antelope Valley
Recruiting
Lancaster
Cedars Sinai Medical Center
Recruiting
Los Angeles
Los Angeles County-USC Medical Center
Recruiting
Los Angeles
USC / Norris Comprehensive Cancer Center
Recruiting
Los Angeles
Fremont - Rideout Cancer Center
Recruiting
Marysville
Kaiser Permanente-Modesto
Recruiting
Modesto
Kaiser Permanente Oakland-Broadway
Recruiting
Oakland
Kaiser Permanente-Oakland
Recruiting
Oakland
Stanford Cancer Institute Palo Alto
Recruiting
Palo Alto
Kaiser Permanente-Rancho Cordova Cancer Center
Recruiting
Rancho Cordova
Kaiser Permanente- Marshall Medical Offices
Recruiting
Redwood City
Kaiser Permanente-Richmond
Recruiting
Richmond
Rohnert Park Cancer Center
Recruiting
Rohnert Park
Kaiser Permanente-Roseville
Recruiting
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Recruiting
Roseville
Sutter Roseville Medical Center
Recruiting
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Recruiting
Roseville
Kaiser Permanente Downtown Commons
Recruiting
Sacramento
Kaiser Permanente-South Sacramento
Recruiting
Sacramento
South Sacramento Cancer Center
Recruiting
Sacramento
Sutter Medical Center Sacramento
Recruiting
Sacramento
University of California Davis Comprehensive Cancer Center
Recruiting
Sacramento
Naval Medical Center -San Diego
Active, not recruiting
San Diego
UC San Diego Medical Center - Hillcrest
Recruiting
San Diego
Kaiser Permanente-San Francisco
Recruiting
San Francisco
UCSF Medical Center-Mission Bay
Recruiting
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
Recruiting
San Jose
Stanford Cancer Center South Bay
Recruiting
San Jose
Kaiser Permanente San Leandro
Recruiting
San Leandro
Kaiser San Rafael-Gallinas
Recruiting
San Rafael
Kaiser Permanente Medical Center - Santa Clara
Recruiting
Santa Clara
Kaiser Permanente-Santa Rosa
Recruiting
Santa Rosa
City of Hope South Pasadena
Recruiting
South Pasadena
Kaiser Permanente Cancer Treatment Center
Recruiting
South San Francisco
Kaiser Permanente-South San Francisco
Recruiting
South San Francisco
Kaiser Permanente-Stockton
Recruiting
Stockton
City of Hope South Bay
Recruiting
Torrance
Torrance Memorial Medical Center
Recruiting
Torrance
Torrance Memorial Physician Network - Cancer Care
Recruiting
Torrance
City of Hope Upland
Recruiting
Upland
Kaiser Permanente Medical Center-Vacaville
Recruiting
Vacaville
Kaiser Permanente-Vallejo
Recruiting
Vallejo
Kaiser Permanente-Walnut Creek
Recruiting
Walnut Creek
Colorado
Rocky Mountain Regional VA Medical Center
Recruiting
Aurora
University of Colorado Hospital
Active, not recruiting
Aurora
Rocky Mountain Cancer Centers-Boulder
Recruiting
Boulder
Memorial Hospital North
Active, not recruiting
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
Recruiting
Colorado Springs
UCHealth Memorial Hospital Central
Active, not recruiting
Colorado Springs
Porter Adventist Hospital
Recruiting
Denver
Cancer Care and Hematology-Fort Collins
Active, not recruiting
Fort Collins
Poudre Valley Hospital
Active, not recruiting
Fort Collins
UCHealth Greeley Hospital
Active, not recruiting
Greeley
Littleton Adventist Hospital
Recruiting
Littleton
Medical Center of the Rockies
Active, not recruiting
Loveland
Parker Adventist Hospital
Recruiting
Parker
Connecticut
Hartford Hospital
Recruiting
Hartford
Delaware
Christiana Care Health System-Christiana Hospital
Recruiting
Newark
Delaware Clinical and Laboratory Physicians PA
Recruiting
Newark
Helen F Graham Cancer Center
Recruiting
Newark
Medical Oncology Hematology Consultants PA
Recruiting
Newark
Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables
Recruiting
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Springs
Recruiting
Coral Springs
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Recruiting
Deerfield Beach
Miami Cancer Institute
Recruiting
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Recruiting
Miami
Orlando Health Cancer Institute
Recruiting
Orlando
Moffitt Cancer Center
Recruiting
Tampa
Moffitt Cancer Center - McKinley Campus
Recruiting
Tampa
Moffitt Cancer Center-International Plaza
Recruiting
Tampa
Moffitt Cancer Center at Wesley Chapel
Recruiting
Wesley Chapel
Georgia
Emory University Hospital Midtown
Recruiting
Atlanta
Grady Health System
Recruiting
Atlanta
Hawaii
Hawaii Cancer Care - Savio
Recruiting
'aiea
Pali Momi Medical Center
Recruiting
'aiea
Hawaii Cancer Care Inc - Waterfront Plaza
Recruiting
Honolulu
Hawaii Cancer Care Inc-Liliha
Recruiting
Honolulu
Kaiser Permanente Moanalua Medical Center
Recruiting
Honolulu
Kapiolani Medical Center for Women and Children
Recruiting
Honolulu
Kuakini Medical Center
Recruiting
Honolulu
Queen's Cancer Cenrer - POB I
Recruiting
Honolulu
Queen's Cancer Center - Kuakini
Recruiting
Honolulu
Queen's Medical Center
Recruiting
Honolulu
Straub Clinic and Hospital
Recruiting
Honolulu
The Cancer Center of Hawaii-Liliha
Recruiting
Honolulu
University of Hawaii Cancer Center
Recruiting
Honolulu
Wilcox Memorial Hospital and Kauai Medical Clinic
Recruiting
Lihue
Iowa
Medical Oncology and Hematology Associates-West Des Moines
Suspended
Clive
Mercy Cancer Center-West Lakes
Suspended
Clive
Greater Regional Medical Center
Suspended
Creston
Broadlawns Medical Center
Recruiting
Des Moines
Iowa Lutheran Hospital
Recruiting
Des Moines
Iowa Methodist Medical Center
Recruiting
Des Moines
Medical Oncology and Hematology Associates-Des Moines
Recruiting
Des Moines
Mercy Medical Center - Des Moines
Suspended
Des Moines
Mission Cancer and Blood - Laurel
Suspended
Des Moines
Mercy Medical Center-West Lakes
Suspended
West Des Moines
Methodist West Hospital
Recruiting
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
Recruiting
Boise
Saint Luke's Cancer Institute - Boise
Recruiting
Boise
Saint Alphonsus Cancer Care Center-Caldwell
Recruiting
Caldwell
Saint Luke's Cancer Institute - Fruitland
Recruiting
Fruitland
Saint Luke's Cancer Institute - Meridian
Recruiting
Meridian
Saint Alphonsus Medical Center-Nampa
Recruiting
Nampa
Saint Luke's Cancer Institute - Nampa
Recruiting
Nampa
Saint Luke's Cancer Institute - Twin Falls
Recruiting
Twin Falls
Illinois
Rush - Copley Medical Center
Recruiting
Aurora
Illinois CancerCare-Bloomington
Recruiting
Bloomington
Illinois CancerCare-Canton
Recruiting
Canton
Illinois CancerCare-Carthage
Recruiting
Carthage
Centralia Oncology Clinic
Recruiting
Centralia
Northwestern University
Recruiting
Chicago
Rush University Medical Center
Active, not recruiting
Chicago
Cancer Care Specialists of Illinois - Decatur
Recruiting
Decatur
Decatur Memorial Hospital
Recruiting
Decatur
Northwestern Medicine Cancer Center Kishwaukee
Recruiting
Dekalb
Crossroads Cancer Center
Recruiting
Effingham
Illinois CancerCare-Eureka
Recruiting
Eureka
NorthShore University HealthSystem-Evanston Hospital
Recruiting
Evanston
Illinois CancerCare-Galesburg
Recruiting
Galesburg
Western Illinois Cancer Treatment Center
Recruiting
Galesburg
Northwestern Medicine Cancer Center Delnor
Recruiting
Geneva
NorthShore University HealthSystem-Glenbrook Hospital
Recruiting
Glenview
NorthShore University HealthSystem-Highland Park Hospital
Recruiting
Highland Park
Illinois CancerCare-Kewanee Clinic
Recruiting
Kewanee
Illinois CancerCare-Macomb
Recruiting
Macomb
Loyola University Medical Center
Recruiting
Maywood
Cancer Care Center of O'Fallon
Recruiting
O'fallon
Illinois CancerCare-Ottawa Clinic
Recruiting
Ottawa
Illinois CancerCare-Pekin
Recruiting
Pekin
Illinois CancerCare-Peoria
Recruiting
Peoria
Methodist Medical Center of Illinois
Recruiting
Peoria
OSF Saint Francis Medical Center
Recruiting
Peoria
Illinois CancerCare-Peru
Recruiting
Peru
Illinois CancerCare-Princeton
Recruiting
Princeton
SwedishAmerican Regional Cancer Center/ACT
Recruiting
Rockford
Memorial Hospital East
Recruiting
Shiloh
Memorial Medical Center
Recruiting
Springfield
Southern Illinois University School of Medicine
Recruiting
Springfield
Springfield Clinic
Recruiting
Springfield
Northwestern Medicine Cancer Center Warrenville
Recruiting
Warrenville
Illinois CancerCare - Washington
Recruiting
Washington
Indiana
IU Health North Hospital
Recruiting
Carmel
Indiana University/Melvin and Bren Simon Cancer Center
Recruiting
Indianapolis
Sidney and Lois Eskenazi Hospital
Recruiting
Indianapolis
Kansas
University of Kansas Cancer Center
Recruiting
Kansas City
Lawrence Memorial Hospital
Suspended
Lawrence
University of Kansas Cancer Center-Overland Park
Recruiting
Overland Park
Salina Regional Health Center
Recruiting
Salina
University of Kansas Health System Saint Francis Campus
Recruiting
Topeka
University of Kansas Hospital-Westwood Cancer Center
Recruiting
Westwood
Kentucky
University of Kentucky/Markey Cancer Center
Recruiting
Lexington
Jewish Hospital
Suspended
Louisville
Norton Brownsboro Hospital and Medical Campus
Recruiting
Louisville
Norton Hospital Pavilion and Medical Campus
Recruiting
Louisville
The James Graham Brown Cancer Center at University of Louisville
Recruiting
Louisville
Louisiana
Louisiana Hematology Oncology Associates LLC
Active, not recruiting
Baton Rouge
LSU Health Baton Rouge-North Clinic
Active, not recruiting
Baton Rouge
Mary Bird Perkins Cancer Center
Active, not recruiting
Baton Rouge
Our Lady of the Lake Physicians Group - Medical Oncology
Active, not recruiting
Baton Rouge
East Jefferson General Hospital
Active, not recruiting
Metairie
Massachusetts
Boston Medical Center
Recruiting
Boston
Dana-Farber Cancer Institute
Recruiting
Boston
Maryland
Greater Baltimore Medical Center
Recruiting
Baltimore
University of Maryland/Greenebaum Cancer Center
Recruiting
Baltimore
UM Upper Chesapeake Medical Center
Recruiting
Bel Air
Maine
MaineHealth Coastal Cancer Treatment Center
Active, not recruiting
Bath
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Active, not recruiting
Biddeford
Maine Medical Center-Bramhall Campus
Active, not recruiting
Portland
Penobscot Bay Medical Center
Active, not recruiting
Rockport
MaineHealth Cancer Care Center of York County
Active, not recruiting
Sanford
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Active, not recruiting
Sanford
Maine Medical Center- Scarborough Campus
Active, not recruiting
Scarborough
Maine Medical Partners - South Portland
Active, not recruiting
South Portland
Michigan
Saint Joseph Mercy Hospital
Recruiting
Ann Arbor
McLaren Cancer Institute-Bay City
Recruiting
Bay City
Saint Joseph Mercy Brighton
Recruiting
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Recruiting
Brighton
Henry Ford Cancer Institute-Downriver
Recruiting
Brownstown
Saint Joseph Mercy Canton
Recruiting
Canton
Trinity Health IHA Medical Group Hematology Oncology - Canton
Recruiting
Canton
Caro Cancer Center
Recruiting
Caro
Saint Joseph Mercy Chelsea
Recruiting
Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Recruiting
Chelsea
McLaren Cancer Institute-Clarkston
Recruiting
Clarkston
Henry Ford Macomb Hospital-Clinton Township
Recruiting
Clinton Township
Henry Ford Medical Center-Fairlane
Recruiting
Dearborn
Henry Ford Hospital
Recruiting
Detroit
Wayne State University/Karmanos Cancer Institute
Recruiting
Detroit
Weisberg Cancer Treatment Center
Recruiting
Farmington Hills
McLaren Cancer Institute-Flint
Recruiting
Flint
Singh and Arora Hematology Oncology PC
Recruiting
Flint
Helen DeVos Children's Hospital at Spectrum Health
Recruiting
Grand Rapids
Mercy Health Saint Mary's
Recruiting
Grand Rapids
Spectrum Health at Butterworth Campus
Recruiting
Grand Rapids
Karmanos Cancer Institute at McLaren Greater Lansing
Recruiting
Lansing
Mid-Michigan Physicians-Lansing
Recruiting
Lansing
Sparrow Hospital
Recruiting
Lansing
McLaren Cancer Institute-Lapeer Region
Recruiting
Lapeer
Trinity Health Saint Mary Mercy Livonia Hospital
Recruiting
Livonia
Saint Mary's Oncology/Hematology Associates of Marlette
Recruiting
Marlette
McLaren Cancer Institute-Macomb
Recruiting
Mount Clemens
Lakeland Hospital Niles
Recruiting
Niles
Henry Ford Medical Center-Columbus
Recruiting
Novi
McLaren Cancer Institute-Northern Michigan
Recruiting
Petoskey
McLaren-Port Huron
Recruiting
Port Huron
Ascension Saint Mary's Hospital
Recruiting
Saginaw
Oncology Hematology Associates of Saginaw Valley PC
Recruiting
Saginaw
Lakeland Medical Center Saint Joseph
Recruiting
Saint Joseph
Marie Yeager Cancer Center
Recruiting
Saint Joseph
Henry Ford Macomb Health Center - Shelby Township
Suspended
Shelby
Ascension Saint Joseph Hospital
Recruiting
Tawas City
Henry Ford West Bloomfield Hospital
Recruiting
West Bloomfield
Saint Mary's Oncology/Hematology Associates of West Branch
Recruiting
West Branch
Metro Health Hospital
Recruiting
Wyoming
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Recruiting
Ypsilanti
Minnesota
Sanford Joe Lueken Cancer Center
Recruiting
Bemidji
Essentia Health Saint Joseph's Medical Center
Recruiting
Brainerd
Essentia Health - Deer River Clinic
Recruiting
Deer River
Essentia Health Cancer Center
Recruiting
Duluth
Essentia Health Saint Mary's Medical Center
Recruiting
Duluth
Miller-Dwan Hospital
Recruiting
Duluth
Essentia Health Hibbing Clinic
Recruiting
Hibbing
Coborn Cancer Center at Saint Cloud Hospital
Recruiting
Saint Cloud
Essentia Health Sandstone
Recruiting
Sandstone
Essentia Health Virginia Clinic
Recruiting
Virginia
Missouri
Saint Francis Medical Center
Recruiting
Cape Girardeau
Siteman Cancer Center at West County Hospital
Recruiting
Creve Coeur
Parkland Health Center - Farmington
Recruiting
Farmington
Freeman Health System
Recruiting
Joplin
University of Kansas Cancer Center - North
Recruiting
Kansas City
University of Kansas Cancer Center - Lee's Summit
Recruiting
Lee's Summit
Delbert Day Cancer Institute at PCRMC
Recruiting
Rolla
Mercy Clinic-Rolla-Cancer and Hematology
Recruiting
Rolla
Siteman Cancer Center-South County
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Recruiting
Saint Peters
Mercy Hospital Springfield
Recruiting
Springfield
Montana
Bozeman Deaconess Hospital
Recruiting
Bozeman
Benefis Healthcare- Sletten Cancer Institute
Recruiting
Great Falls
North Carolina
Atrium Health Pineville/LCI-Pineville
Recruiting
Charlotte
Atrium Health University City/LCI-University
Recruiting
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Recruiting
Charlotte
Levine Cancer Institute-Ballantyne
Recruiting
Charlotte
Novant Health Presbyterian Medical Center
Recruiting
Charlotte
Wake Forest University at Clemmons
Recruiting
Clemmons
Atrium Health Cabarrus/LCI-Concord
Recruiting
Concord
CaroMont Regional Medical Center
Active, not recruiting
Gastonia
East Carolina University
Recruiting
Greenville
Novant Health Cancer Institute - Huntersville
Recruiting
Huntersville
Novant Health Presbyterian Medical Center Huntersville
Recruiting
Huntersville
Novant Health Cancer Institute - Kernersville
Recruiting
Kernersville
Novant Health Cancer Institute - Matthews
Recruiting
Matthews
Atrium Health Union/LCI-Union
Recruiting
Monroe
Novant Health Cancer Institute - Mooresville
Recruiting
Mooresville
Novant Health Cancer Institute - Mount Airy
Recruiting
Mount Airy
FirstHealth of the Carolinas-Moore Regional Hospital
Recruiting
Pinehurst
Novant Health Cancer Institute - Statesville
Recruiting
Statesville
Wake Forest Baptist Health - Hematology Oncology - Statesville
Recruiting
Statesville
Novant Cancer Institute Radiation Oncology - Supply
Recruiting
Supply
Novant Health Cancer Institute - Thomasville
Recruiting
Thomasville
Novant Health Cancer Institute - Wilkesboro
Recruiting
Wilkesboro
Wake Forest Baptist Health - Wilkes Medical Center
Recruiting
Wilkesboro
Novant Health Cancer Institute Radiation Oncology - Wilmington
Recruiting
Wilmington
Novant Health New Hanover Regional Medical Center
Recruiting
Wilmington
Novant Health Forsyth Medical Center
Recruiting
Winston-salem
Wake Forest University Health Sciences
Recruiting
Winston-salem
North Dakota
Sanford Bismarck Medical Center
Recruiting
Bismarck
Sanford Broadway Medical Center
Recruiting
Fargo
Sanford Roger Maris Cancer Center
Recruiting
Fargo
Nebraska
CHI Health Good Samaritan
Recruiting
Kearney
University of Nebraska Medical Center
Recruiting
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
Recruiting
Lebanon
New Jersey
Rutgers Cancer Institute of New Jersey
Recruiting
New Brunswick
Community Medical Center
Recruiting
Toms River
New Mexico
New Mexico Oncology Hematology Consultants
Recruiting
Albuquerque
University of New Mexico Cancer Center
Recruiting
Albuquerque
Nevada
Renown Regional Medical Center
Recruiting
Reno
New York
Noyes Memorial Hospital/Myers Cancer Center
Recruiting
Dansville
Upstate Cancer Center at Oneida
Recruiting
Oneida
Upstate Cancer Center at Oswego
Recruiting
Oswego
Highland Hospital
Recruiting
Rochester
University of Rochester
Recruiting
Rochester
Stony Brook University Medical Center
Recruiting
Stony Brook
State University of New York Upstate Medical University
Recruiting
Syracuse
SUNY Upstate Medical Center-Community Campus
Recruiting
Syracuse
Ohio
Summa Health System - Akron Campus
Recruiting
Akron
Summa Health System - Barberton Campus
Recruiting
Barberton
Geauga Hospital
Recruiting
Chardon
University of Cincinnati Cancer Center-UC Medical Center
Recruiting
Cincinnati
Case Western Reserve University
Recruiting
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Recruiting
Cleveland
Cleveland Clinic Foundation
Recruiting
Cleveland
MetroHealth Medical Center
Recruiting
Cleveland
Ohio State University Comprehensive Cancer Center
Recruiting
Columbus
Cleveland Clinic Cancer Center Mansfield
Recruiting
Mansfield
Hillcrest Hospital Cancer Center
Recruiting
Mayfield Heights
Summa Health Medina Medical Center
Recruiting
Medina
UH Seidman Cancer Center at Lake Health Mentor Campus
Recruiting
Mentor
UH Seidman Cancer Center at Southwest General Hospital
Recruiting
Middleburg Heights
University Hospitals Parma Medical Center
Recruiting
Parma
Mercy Health Perrysburg Cancer Center
Recruiting
Perrysburg
University Hospitals Portage Medical Center
Recruiting
Ravenna
North Coast Cancer Care
Recruiting
Sandusky
Cleveland Clinic Cancer Center Strongsville
Recruiting
Strongsville
ProMedica Flower Hospital
Recruiting
Sylvania
Mercy Health - Saint Anne Hospital
Recruiting
Toledo
Saint Vincent Mercy Medical Center
Recruiting
Toledo
University of Cincinnati Cancer Center-West Chester
Recruiting
West Chester
UH Seidman Cancer Center at Saint John Medical Center
Recruiting
Westlake
UHHS-Westlake Medical Center
Recruiting
Westlake
Cleveland Clinic Wooster Family Health and Surgery Center
Recruiting
Wooster
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Oregon
Clackamas Radiation Oncology Center
Recruiting
Clackamas
Providence Cancer Institute Clackamas Clinic
Recruiting
Clackamas
Providence Newberg Medical Center
Recruiting
Newberg
Kaiser Permanente Northwest
Recruiting
Portland
Providence Portland Medical Center
Recruiting
Portland
Providence Saint Vincent Medical Center
Recruiting
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Recruiting
Allentown
UPMC Altoona
Recruiting
Altoona
UPMC-Heritage Valley Health System Beaver
Recruiting
Beaver
Carlisle Regional Cancer Center
Recruiting
Carlisle
Christiana Care Health System-Concord Health Center
Recruiting
Chadds Ford
Geisinger Medical Center
Recruiting
Danville
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
Recruiting
East Norriton
Ephrata Cancer Center
Recruiting
Ephrata
UPMC Hillman Cancer Center Erie
Recruiting
Erie
UPMC Cancer Center at UPMC Horizon
Recruiting
Farrell
Fox Chase Cancer Center Buckingham
Recruiting
Furlong
Adams Cancer Center
Recruiting
Gettysburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Recruiting
Greensburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Recruiting
Harrisburg
Penn State Milton S Hershey Medical Center
Recruiting
Hershey
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Recruiting
Johnstown
Geisinger Medical Oncology-Lewisburg
Recruiting
Lewisburg
Lewistown Hospital
Recruiting
Lewistown
UPMC Cancer Center at UPMC McKeesport
Recruiting
Mckeesport
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Recruiting
Mechanicsburg
Forbes Hospital
Recruiting
Monroeville
UPMC Cancer Center - Monroeville
Recruiting
Monroeville
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Recruiting
Moon
Fox Chase Cancer Center
Recruiting
Philadelphia
Jefferson Torresdale Hospital
Recruiting
Philadelphia
Temple University Hospital
Active, not recruiting
Philadelphia
Thomas Jefferson University Hospital
Recruiting
Philadelphia
Allegheny General Hospital
Recruiting
Pittsburgh
UPMC-Magee Womens Hospital
Recruiting
Pittsburgh
UPMC-Passavant Hospital
Recruiting
Pittsburgh
UPMC-Saint Clair Hospital Cancer Center
Recruiting
Pittsburgh
UPMC-Saint Margaret
Recruiting
Pittsburgh
UPMC-Shadyside Hospital
Recruiting
Pittsburgh
Geisinger Cancer Services-Pottsville
Recruiting
Pottsville
UPMC Cancer Center at UPMC Northwest
Recruiting
Seneca
UPMC Uniontown Hospital Radiation Oncology
Recruiting
Uniontown
UPMC Washington Hospital Radiation Oncology
Recruiting
Washington
Reading Hospital
Recruiting
West Reading
Wexford Health and Wellness Pavilion
Recruiting
Wexford
Geisinger Wyoming Valley/Henry Cancer Center
Recruiting
Wilkes-barre
UPMC Memorial
Recruiting
York
WellSpan Health-York Cancer Center
Recruiting
York
WellSpan Health-York Hospital
Recruiting
York
South Carolina
Medical University of South Carolina
Recruiting
Charleston
Gibbs Cancer Center-Gaffney
Recruiting
Gaffney
Tidelands Georgetown Memorial Hospital
Recruiting
Georgetown
Prisma Health Cancer Institute - Eastside
Recruiting
Greenville
Prisma Health Cancer Institute - Faris
Recruiting
Greenville
Saint Francis Cancer Center
Recruiting
Greenville
Saint Francis Hospital
Recruiting
Greenville
Gibbs Cancer Center-Pelham
Recruiting
Greer
Prisma Health Cancer Institute - Greer
Recruiting
Greer
Levine Cancer Institute-Rock Hill
Recruiting
Rock Hill
Rock Hill Radiation Therapy Center
Recruiting
Rock Hill
Prisma Health Cancer Institute - Seneca
Recruiting
Seneca
Spartanburg Medical Center
Recruiting
Spartanburg
MGC Hematology Oncology-Union
Recruiting
Union
South Dakota
Avera Cancer Institute
Recruiting
Sioux Falls
Sanford Cancer Center Oncology Clinic
Recruiting
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Recruiting
Sioux Falls
Tennessee
The West Clinic - Wolf River
Recruiting
Germantown
University of Tennessee - Knoxville
Recruiting
Knoxville
Vanderbilt University/Ingram Cancer Center
Recruiting
Nashville
Texas
The Don and Sybil Harrington Cancer Center
Recruiting
Amarillo
Utah
American Fork Hospital / Huntsman Intermountain Cancer Center
Recruiting
American Fork
Farmington Health Center
Recruiting
Farmington
Logan Regional Hospital
Recruiting
Logan
Intermountain Medical Center
Recruiting
Murray
McKay-Dee Hospital Center
Recruiting
Ogden
Utah Valley Regional Medical Center
Recruiting
Provo
Riverton Hospital
Recruiting
Riverton
Saint George Regional Medical Center
Recruiting
Saint George
Huntsman Cancer Institute/University of Utah
Recruiting
Salt Lake City
LDS Hospital
Recruiting
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Recruiting
Salt Lake City
Virginia
Inova Fair Oaks Hospital
Recruiting
Fairfax
Inova Schar Cancer Institute
Recruiting
Fairfax
Naval Medical Center - Portsmouth
Recruiting
Portsmouth
VCU Massey Cancer Center at Stony Point
Recruiting
Richmond
Virginia Commonwealth University/Massey Cancer Center
Recruiting
Richmond
Vermont
Norris Cotton Cancer Center-North
Recruiting
Saint Johnsbury
Washington
Swedish Medical Center-Ballard Campus
Recruiting
Seattle
Swedish Medical Center-First Hill
Recruiting
Seattle
Providence Saint Mary Regional Cancer Center
Recruiting
Walla Walla
Wisconsin
Langlade Hospital and Cancer Center
Recruiting
Antigo
Ascension Saint Elizabeth Hospital
Recruiting
Appleton
Duluth Clinic Ashland
Recruiting
Ashland
Northwest Wisconsin Cancer Center
Recruiting
Ashland
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Recruiting
Brookfield
Aurora Cancer Care-Southern Lakes VLCC
Recruiting
Burlington
Ascension Calumet Hospital
Recruiting
Chilton
HSHS Sacred Heart Hospital
Recruiting
Eau Claire
Ascension Saint Francis - Reiman Cancer Center
Recruiting
Franklin
Ascension Southeast Wisconsin Hospital - Franklin
Recruiting
Franklin
Aurora Health Care Germantown Health Center
Recruiting
Germantown
Aurora Cancer Care-Grafton
Recruiting
Grafton
Aurora BayCare Medical Center
Recruiting
Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
Recruiting
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Recruiting
Green Bay
Essentia Health-Hayward Clinic
Recruiting
Hayward
UW Cancer Center Johnson Creek
Recruiting
Johnson Creek
Aurora Cancer Care-Kenosha South
Recruiting
Kenosha
Gundersen Lutheran Medical Center
Recruiting
La Crosse
University of Wisconsin Carbone Cancer Center
Recruiting
Madison
Aurora Bay Area Medical Group-Marinette
Recruiting
Marinette
Froedtert Menomonee Falls Hospital
Recruiting
Menomonee Falls
Ascension Columbia Saint Mary's Hospital Ozaukee
Recruiting
Mequon
Ascension Columbia Saint Mary's Hospital - Milwaukee
Recruiting
Milwaukee
Ascension Saint Francis Hospital
Recruiting
Milwaukee
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Recruiting
Milwaukee
Aurora Cancer Care-Milwaukee
Recruiting
Milwaukee
Aurora Saint Luke's Medical Center
Recruiting
Milwaukee
Aurora Sinai Medical Center
Recruiting
Milwaukee
Medical College of Wisconsin
Recruiting
Milwaukee
Ascension Mercy Hospital
Recruiting
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Recruiting
Oshkosh
Ascension All Saints Hospital
Recruiting
Racine
Aurora Cancer Care-Racine
Recruiting
Racine
Vince Lombardi Cancer Clinic-Sheboygan
Recruiting
Sheboygan
Essentia Health-Spooner Clinic
Recruiting
Spooner
Aurora Medical Center in Summit
Recruiting
Summit
Essentia Health Saint Mary's Hospital - Superior
Recruiting
Superior
Vince Lombardi Cancer Clinic-Two Rivers
Recruiting
Two Rivers
Aspirus Regional Cancer Center
Recruiting
Wausau
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Recruiting
Wauwatosa
Aurora Cancer Care-Milwaukee West
Recruiting
Wauwatosa
Aurora West Allis Medical Center
Recruiting
West Allis
Froedtert West Bend Hospital/Kraemer Cancer Center
Recruiting
West Bend
Aspirus Cancer Care - Wisconsin Rapids
Recruiting
Wisconsin Rapids
Time Frame
Start Date: July 10, 2019
Estimated Completion Date: February 28, 2025
Participants
Target number of participants: 711
Treatments
Active Comparator: Arm I (IMRT, IGRT, cisplatin)
Patients undergo IMRT or IGRT over 6 fractions per week and receive cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (IMRT, IGRT, cisplatin)
Patients undergo reduced dose IMRT or IGRT QD over 5 fractions per week and receive cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
Experimental: Arm III (IMRT, IGRT, nivolumab)
Beginning 1 week prior to radiation, patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity.
Authors
Randall J. Kimple, Laila A. Gharzai, Jeffrey A. Kittel, John F. Deeken, Charles S. Kuzma, Desiree E. Doncals, Natalie A. Lockney, Musaddiq J. Awan, Mitchell Machtay, Sharon A. Spencer, Michael A. Samuels, Robert J. Behrens, Minh T. Truong, Matthew L. Ryan, Jonathan J. Beitler, Jennifer A. Dorth, Bryan A. Faller, Jennifer E. Tseng, Min Yao, Preston D. Steen, Kevin S. Roof, Charles E. Rutter, Jared R. Robbins, Vilija N. Avizonis, Yuhchyau Chen, Alec M. Block, Bruce J. Averbook, Adam Garsa, Chanh T. Huynh, Erika L. Swanson, Jay W. Carlson, Kartik M. Mani, Wade L. Thorstad, Neal E. Dunlap, Kalika P. Sarma, Matthew J. Ferris, Erin R. Alesi, Stuart E. Samuels, Loren K. Mell, Sue S. Yom, Anand K. Sharma, Donald J. Jurgens, Patrick D. Maguire, Jessica L. Geiger, Timothy D. Moore, Bruce E. Brockstein, Zachary S. Zumsteg, Paul M. Barr, Youssef M. Arshoun, Christopher U. Jones, Emory McTyre, Krishna C. Alluri, John M. Schallenkamp, Michael L. Haas, Richard J. Bold, Gregory A. Masters, Matthew C. Ward, Ammar Sukari, Jennifer Vogel, Matthew D. Cheney, Robert M. Doline, Shyam S. Rao, Beth M. Beadle, Eleanor M. Walker, Weining Zhen, Joshua Lukenbill, Sagus Sampath, Mahesh R. Kudrimoti, Thomas J. Galloway, Siddhartha Padmanabha, Michael D. Zurenko, Gary V. Walker, Jonathan R. Bear, Samir Narayan, Nicholas DiBella, Christina Henson, Nadia N. Ramdin, Sung Kim, Jeffrey A. Forquer, Ryan T. Hughes, Collin D. Driscoll, Bharat B. Mittal, Salah M. Almokadem, Heath D. Skinner, Ying J. Hitchcock, Samantha A. Seaward, Dan S. Zuckerman, David S. Hanson, Philip E. Schaner, Benjamin M. Solomon, Sana D. Karam, Andrew W. Ju, Kathryn M. Greven, Jessica D. McDermott, Timothy J. Panella, Michael A. Lacombe, Jennifer L. Harper, Albert Attia, Quynh-Thu X. Le, Sandeep H. Mashru, Harvey E. Einhorn, Bret E. Friday, Aaron C. Spalding, Anita Ravipati, Richard L. Deming, Demetria I. Jacks, Michael J. Jelinek, Danielle N. Margalit, Voichita Bar Ad, Michelle S. Gentile, Andrew S. Camarata, Christopher S. Platta, Sarah W. Gordon, Kruti Patel, Richard Y. Lee, Noam A. VanderWalde, Shannon Offerman, Christopher Lominska, Noah S. Kalman, Jimmy J. Caudell, Dukagjin M. Blakaj, Amarinthia (Amy) Curtis, Vinita Takiar, Kathleen J. Yost, John A. Ellerton, Nitya Alluri, David Y. Lee, William Tse, Greg Durm, William Stokes
Sponsors
Collaborators: NRG Oncology
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials