Spots Global Cancer Trial Database for Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer
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Trial Identification
Brief Title: Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer
Official Title: A Randomized Phase II Trial for Patients With p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer
Study ID: NCT02254278
Study Description
Brief Summary: 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.
Detailed Description: PRIMARY OBJECTIVES: -To select the arm(s) achieving a 2-year progression-free survival rate of \>= 85% without unacceptable swallowing toxicity at 1 year. SECONDARY OBJECTIVES: * To determine patterns of failure (locoregional relapse versus distant) and survival -(overall and progression-free) at 6 months and 2 years. * To determine acute toxicity profiles at the end of radiation therapy and at 1 and 6 months. * To determine late toxicity profiles at 1 and 2 years. * To determine patient-reported swallowing outcomes at 6 months and 1 and 2 years. * 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. * To determine the predictive value of blood and tissue biomarkers for disease outcomes at 2 years. * To determine swallowing recovery per videofluoroscopy imaging at 2 years. After completion of study treatment, patients are followed at 1 and 3 months then every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Banner University Medical Center - Tucson, Tucson, Arizona, United States
Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States
Mills-Peninsula Medical Center, Burlingame, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Marin General Hospital, Greenbrae, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
Memorial Medical Center, Modesto, California, United States
Kaiser Permanente Oakland-Broadway, Oakland, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
Palo Alto Medical Foundation Health Care, Palo Alto, California, United States
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova, California, United States
Rohnert Park Cancer Center, Rohnert Park, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, United States
The Permanente Medical Group-Roseville Radiation Oncology, Roseville, California, United States
Sutter Medical Center Sacramento, Sacramento, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
South Sacramento Cancer Center, Sacramento, California, United States
Saint Helena Hospital, Saint Helena, California, United States
Naval Medical Center -San Diego, San Diego, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
Stanford Cancer Center South Bay, San Jose, California, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
City of Hope South Pasadena, South Pasadena, California, United States
Kaiser Permanente Cancer Treatment Center, South San Francisco, California, United States
Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center, Truckee, California, United States
John Muir Medical Center-Walnut Creek, Walnut Creek, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
Parker Adventist Hospital, Parker, Colorado, United States
Yale University, New Haven, Connecticut, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
Memorial Hospital West, Pembroke Pines, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Cleveland Clinic-Weston, Weston, Florida, United States
Grady Health System, Atlanta, Georgia, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Piedmont Hospital, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States
Queen's Medical Center, Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Northwestern University, Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital, Highland Park, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Radiation Oncology Associates PC, Fort Wayne, Indiana, United States
Parkview Hospital Randallia, Fort Wayne, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Olathe Medical Center, Olathe, Kansas, United States
University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
Ascension Via Christi Hospitals Wichita, Wichita, Kansas, United States
The James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, United States
Jewish Hospital Medical Center Northeast, Louisville, Kentucky, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Boston Medical Center, Boston, Massachusetts, United States
Lahey Hospital and Medical Center, Burlington, Massachusetts, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Henry Ford Cancer Institute-Downriver, Brownstown, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township, Clinton Township, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Mercy Health Saint Mary's, Grand Rapids, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Mercy Health Mercy Campus, Muskegon, Michigan, United States
Lakeland Medical Center Saint Joseph, Saint Joseph, Michigan, United States
Henry Ford West Bloomfield Hospital, West Bloomfield, Michigan, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
North Kansas City Hospital, Kansas City, Missouri, United States
The University of Kansas Cancer Center-South, Kansas City, Missouri, United States
The University of Kansas Cancer Center-North, Kansas City, Missouri, United States
The University of Kansas Cancer Center-Lee's Summit, Lee's Summit, Missouri, United States
Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
CHI Health Saint Francis, Grand Island, Nebraska, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States
Alegent Health Lakeside Hospital, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, United States
Renown Regional Medical Center, Reno, Nevada, United States
Saint Mary's Regional Medical Center, Reno, Nevada, United States
Wentworth-Douglass Hospital, Dover, New Hampshire, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Saint Barnabas Medical Center, Livingston, New Jersey, United States
Virtua Memorial, Mount Holly, New Jersey, United States
Virtua Voorhees, Voorhees, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
Dickstein Cancer Treatment Center, White Plains, New York, United States
Mission Hospital Inc-Memorial Campus, Asheville, North Carolina, United States
Vidant Oncology-Kinston, Kinston, North Carolina, United States
NHRMC Radiation Oncology - Supply, Supply, North Carolina, United States
NHRMC Radiation Oncology - 16th Street, Wilmington, North Carolina, United States
UHHS-Chagrin Highlands Medical Center, Beachwood, Ohio, United States
Geauga Hospital, Chardon, Ohio, United States
University of Cincinnati/Barrett Cancer Center, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Mercy Cancer Center-Elyria, Elyria, Ohio, United States
Cleveland Clinic Cancer Center Independence, Independence, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States
UH Seidman Cancer Center at Southwest General Hospital, Middleburg Heights, Ohio, United States
University Hospitals Parma Medical Center, Parma, Ohio, United States
North Coast Cancer Care, Sandusky, Ohio, United States
UH Seidman Cancer Center at Firelands Regional Medical Center, Sandusky, Ohio, United States
Cleveland Clinic Cancer Center Strongsville, Strongsville, Ohio, United States
ProMedica Flower Hospital, Sylvania, Ohio, United States
University Pointe, West Chester, Ohio, United States
UHHS-Westlake Medical Center, Westlake, Ohio, United States
Cleveland Clinic Wooster Family Health and Surgery Center, Wooster, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
UPMC-Heritage Valley Health System Beaver, Beaver, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg, Pennsylvania, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center, Johnstown, Pennsylvania, United States
UPMC Cancer Center at UPMC McKeesport, McKeesport, Pennsylvania, United States
UPMC-Coraopolis/Heritage Valley Radiation Oncology, Moon, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC-Saint Margaret, Pittsburgh, Pennsylvania, United States
UPMC-Shadyside Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Passavant Hospital, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Northwest, Seneca, Pennsylvania, United States
UPMC Uniontown Hospital Radiation Oncology, Uniontown, Pennsylvania, United States
UPMC Washington Hospital Radiation Oncology, Washington, Pennsylvania, United States
Reading Hospital, West Reading, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Greenville Health System Cancer Institute-Faris, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Greer, Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca, Seneca, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg, Spartanburg, South Carolina, United States
Tennessee Cancer Specialists-Dowell Springs, Knoxville, Tennessee, United States
University of Texas Medical Branch, Galveston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
MD Anderson in Katy, Houston, Texas, United States
UTMB Cancer Center at Victory Lakes, League City, Texas, United States
MD Anderson League City, Nassau Bay, Texas, United States
MD Anderson in The Woodlands, The Woodlands, Texas, United States
Intermountain Medical Center, Murray, Utah, United States
McKay-Dee Hospital Center, Ogden, Utah, United States
Utah Cancer Specialists-Salt Lake City, Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Norris Cotton Cancer Center-North, Saint Johnsbury, Vermont, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Tacoma/Valley Radiation Oncology Centers-Gig Harbor, Gig Harbor, Washington, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Tacoma/Valley Radiation Oncology Centers-Jackson Hall, Tacoma, Washington, United States
MultiCare Tacoma General Hospital, Tacoma, Washington, United States
Tacoma/Valley Radiation Oncology Centers-Saint Joe's, Tacoma, Washington, United States
Legacy Salmon Creek Hospital, Vancouver, Washington, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, United States
UW Cancer Center Johnson Creek, Johnson Creek, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Community Memorial Hospital, Menomonee Falls, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Ascension All Saints Hospital, Racine, Wisconsin, United States
HSHS Saint Nicholas Hospital, Sheboygan, Wisconsin, United States
The Alyce and Elmore Kraemer Cancer Care Center, West Bend, Wisconsin, United States
Aspirus UW Cancer Center, Wisconsin Rapids, Wisconsin, United States
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA-Vancouver Island Cancer Centre, Victoria, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Kingston Health Sciences Centre, Kingston, Ontario, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
Windsor Regional Cancer Centre, Windsor, Ontario, Canada
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
McGill University Department of Oncology, Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Saint Lukes Hospital, Dublin, Co Dublin, Ireland
King Faisal Specialist Hospital and Research Centre, Riyadh, , Saudi Arabia
Contact Details
Name: Sue Yom
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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