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RTOG 1216 Protocol Information

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Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck
Protocol Documents
Principal Investigator: Paul M. Harari, MD and David I. Rosenthal, MD
Primary Objective:

Phase II: To select the better experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin

Phase III: To determine whether the selected experimental arm will improve overall survival (OS) over the control arm of radiation and cisplatin

 

Patient Population:

Patients with pathologic stage III or IV head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx (p16 negative), larynx, or hypopharynx. Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink)

Protocol documents are available on the CTSU website. Tracked versions are available from the CTSU Help Desk upon request.

Target Accrual: 675
Current Accrual: 237
Status: Temporarily Closed to Accrual
Date: 2/22/2016
Participating Sites:
Abbott-Northwestern Hospital Minneapolis MN
Advocate Christ Medical Center Oak Lawn IL
Akron General Medical Center Akron OH
Allan Blair Cancer Centre Regina
AnMed Health Cancer Center Anderson SC
Augusta University Medical Center Augusta GA
Aultman Hospital Canton OH
Bay Area Medical Center Marinette WI
Beth Israel Medical Center New York NY
Beth Israel Medical Center New York NY
Borgess Medical Center Kalamazoo MI
Boston Medical Center Boston MA
Bronson Methodist Hospital Kalamazoo MI
Cape Radiation Oncology Cape Girardeau MO
Carle Cancer Center Urbana IL
Case Western Reserve University Cleveland OH
Case Western Reserve University Cleveland OH
Christiana Care Health System-Christiana Hospital Newark DE
Christiana Care Health System-Christiana Hospital Newark DE
City of Hope Comprehensive Cancer Center Duarte CA
Clackamas Radiation Oncology Center Clackamas OR
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland OH
Cleveland Clinic Cancer Center-Independence Independence OH
Cleveland Clinic Foundation Cleveland OH
Cleveland Clinic Foundation Cleveland OH
Cleveland Clinic Wooster Specialty Center Wooster OH
Cleveland Clinic-Strongsville Strongsville OH
Compass Oncology Vancouver Vancouver WA
Covenant Medical Center-Lakeside Lubbock TX
CoxHealth South Hospital Springfield MO
Delbert Day Cancer Institute at PCRMC Rolla MO
Dixie Medical Center Regional Cancer Center East St. George UT
Elkhart General Hospital Elkhart IN
Elkhart General Hospital Elkhart IN
Emory University Hospital Midtown Atlanta GA
Emory University Hospital Midtown Atlanta GA
Emory University Hospital/Winship Cancer Institute Atlanta GA
Emory University Hospital/Winship Cancer Institute Atlanta GA
Fairview Ridges Hospital Burnsville MN
Fairview-Southdale Hospital Edina MN
Florida Hospital Orlando Orlando FL
Fox Chase Cancer Center Philadelphia PA
Fox Chase Cancer Center Philadelphia PA
Fox Chase Cancer Center Buckingham Furlong PA
Freeman Health System Joplin MO
Froedtert and the Medical College of Wisconsin Milwaukee WI
Froedtert and the Medical College of Wisconsin Milwaukee WI
Gibbs Cancer Center-Pelham Greer SC
Goshen Center for Cancer Care Goshen IN
Greater Baltimore Medical Center Baltimore MD
Greater Baltimore Medical Center Baltimore MD
Greenville Health System Cancer Institute-Andrews Greenville SC
Greenville Health System Cancer Institute-Eastside Greenville SC
Greenville Health System Cancer Institute-Faris Greenville SC
Greenville Health System Cancer Institute-Faris Greenville SC
Greenville Health System Cancer Institute-Greer Greer SC
Greenville Health System Cancer Institute-Seneca Seneca SC
Greenville Health System Cancer Institute-Spartanburg Spartanburg SC
Hennepin County Medical Center Minneapolis MN
Henry Ford Hospital Detroit MI
Highland Hospital Rochester NY
Hillcrest Hospital Cancer Center Mayfield Heights OH
Indiana University Health Methodist Hospital Indianapolis IN
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis IN
Intermountain Medical Center Murray UT
Intermountain Medical Center Murray UT
IU Health Central Indiana Cancer Centers Indianapolis IN
IU Health La Porte Hospital La Porte IN
IU Health University West Avon IN
John H Stroger Jr Hospital of Cook County Chicago IL
John H Stroger Jr Hospital of Cook County Chicago IL
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore MD
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Lake University Ireland Cancer Center Mentor OH
Lake/University Seidman Cancer Center Mentor OH
Lakeland Regional Health System St. Joseph MI
LDS Hospital Salt Lake City UT
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah GA
Logan Regional Hospital Logan UT
M D Anderson Cancer Center Houston TX
M D Anderson Cancer Center Houston TX
Mayo Clinic Rochester MN
Mayo Clinic Rochester MN
Mayo Clinic Health System-Franciscan Healthcare LaCrosse WI
McKay-Dee Hospital Center Ogden UT
Memorial Hospital South Bend IN
Memorial Sloan Kettering Basking Ridge Basking Ridge NJ
Memorial Sloan Kettering Basking Ridge Basking Ridge NJ
Memorial Sloan Kettering Cancer Center New York NY
Memorial Sloan Kettering Cancer Center New York NY
Memorial Sloan Kettering Commack Commack NY
Memorial Sloan Kettering Commack Commack NY
Memorial Sloan Kettering Rockville Centre Rockville NY
Memorial Sloan Kettering Rockville Centre Rockville Centre NY
Memorial Sloan Kettering Sleepy Hollow Sleepy Hollow NY
Memorial University Medical Center Savannah GA
Memorial University Medical Center Savannah GA
Mercy General Radiation Oncology Center Sacramento CA
Mercy Hospital Coon Rapids MN
Mercy Hospital Joplin Joplin MO
Mercy Hospital Saint Louis St Louis MO
Mercy Hospital Springfield Springfield MO
Mercy San Juan Medical Center Carmichael CA
Methodist Cancer Center Omaha NE
Metro-Minnesota CCOP St. Louis Park MN
Michiana Hematology Oncology PC-Mishawaka Mishawaka IN
Minnesota Oncology Hematology PA-Maplewood Maplewood MN
Moffitt Cancer Center Tampa FL
Moffitt Cancer Center Tampa FL
North Coast Cancer Care Sandusky OH
North Memorial Medical Health Center Robbinsdale MN
Northern Indiana Cancer Research Consortium South Bend IN
NorthShore University HealthSystem-Evanston Hospital Evanston IL
Northwestern University Chicago IL
Ochsner Medical Center Jefferson New Orleans LA
Ohio State University Comprehensive Cancer Center Columbus OH
Ohio State University Medical Center Columbus OH
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Parkridge University Radiation Oncology Rochester NY
Parkview Hospital Randallia Fort Wayne IN
PeaceHealth Southwest Medical Center Vancouver WA
Penn State University and The Milton S. Hershey Medical Ctr Hershey PA
Penrose-Saint Francis Healthcare Colorado Springs CO
Porter Adventist Hospital Denver CO
Providence Alaska Medical Center Anchorage AK
Providence Milwaukie Hospital Milwaukie OR
Providence Portland Medical Center Portland OR
Providence Portland Medical Center Portland OR
Providence Saint Vincent Medical Center Portland OR
Queen's Medical Center Honolulu HI
Queen's Medical Center Honolulu HI
Radiation Oncology Associates PC Fort Wayne IN
Radiation Oncology Associates PC Fort Wayne IN
Radiological Associates of Sacramento Sacramento CA
Rapid City Regional Hospital Rapid City SD
Reading Hospital Reading PA
Regions Hospital St. Paul MN
Rice Memorial Hospital Willmar MN
Ridgeview Medical Center Waconia MN
Robinson Radiation Oncology Ravenna OH
Roswell Park Cancer Institute Buffalo NY
Rush-Copley Medical Center Aurora IL
Saint John's Hospital - Healtheast Maplewood MN
Saint Joseph Regional Medical Center-Mishawaka Mishawaka IN
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay WI
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay WI
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
Sands Cancer Center Canandaigua NY
Sands Cancer Center Canandiaqua NY
Sentara Cancer Institute at Sentara CarePlex Hospital Hampton VA
Sentara Norfolk General Hospital Norfolk VA
Sentara Virginia Beach General Hospital Virginia Beach VA
Sentara Virginia Beach General Hospital Virginia Beach VA
Siteman Cancer Center at Saint Peters Hospital St. Peters MO
Siteman Cancer Center at West County Hospital St. Louis MO
Siteman Cancer Center at West County Hospital Creve Coeur MO
Siteman Cancer Center-South County St Louis MO
Sparta Cancer Center Sparta NJ
Spartanburg Medical Center Spartanburg SC
Spartanburg Medical Center Spartanburg SC
Stanford Cancer Institute Palo Alto Palo Alto CA
Stanford Cancer Institute Palo Alto Palo Alto CA
State University of New York Upstate Medical University Syracuse NY
State University of New York Upstate Medical University Syracuse NY
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Summa Barberton Hospital Barberton OH
Summa Health Center at Lake Medina Medina OH
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn CA
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park CA
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville CA
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville CA
Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville CA
Sutter Medical Center Sacramento Sacramento CA
Temple University Hospital Philadelphia PA
The Cancer Center of Hawaii-Liliha Honolulu HI
The Cancer Center of Hawaii-Pali Momi Ewa Beach HI
The James Graham Brown Cancer Center at University of Louisville Louisville KY
The James Graham Brown Cancer Center at University of Louisville Louisville KY
The Kirklin Clinic at Acton Road Birmingham AL
The Kirklin Clinic at Acton Road Birmingham AL
The University of Kansas Cancer Center-Lee's Summit Lee's Summit MO
The University of Kansas Cancer Center-North Kansas City MO
The University of Kansas Cancer Center-North Kansas City MO
The University of Kansas Cancer Center-South Kansas City MO
The University of Kansas Cancer Center-South Kansas City MO
Thomas Jefferson University Hospital Philadelphia PA
Thomas Jefferson University Hospital Philadelphia PA
UC San Diego Moores Cancer Center La Jolla CA
UC San Diego Moores Cancer Center LaJolla CA
UCSF Medical Center-Mount Zion San Francisco CA
UCSF Medical Center-Mount Zion San Francisco CA
UF Cancer Center at Orlando Health Orlando FL
UF Cancer Center at Orlando Health Orlando FL
UH Seidman Cancer Center at Southwest General Middleburgh OH
UHHS - Chagrin Highlands Orange Village OH
UHHS-Westlake Medical Center Westlake OH
UNC Lineberger Comprehensive Cancer Center Chapel Hill NC
United Hospital St. Paul MN
Unity Hospital Fridley MN
University of Alabama at Birmingham Cancer Center Birmingham AL
University of Alabama at Birmingham Cancer Center Birmingham AL
University of Arizona Medical Center-University Campus Tucson AZ
University of Arkansas for Medical Sciences Little Rock AR
University of California Davis Comprehensive Cancer Center Sacramento
University of California Davis Comprehensive Cancer Center Sacramento CA
University of Cincinnati/Barrett Cancer Center Cincinnati OH
University of Cincinnati/Barrett Cancer Center Cincinnati OH
University of Colorado Hospital Aurora CO
University of Hawaii Cancer Center Honolulu HI
University of Illinois Chicago IL
University of Kansas Cancer Center Kansas City KS
University of Kansas Cancer Center Kansas City KS
University of Kansas Cancer Center-Overland Park Overland Park KS
University of Kansas Cancer Center-Overland Park Overland Park KS
University of Kentucky/Markey Cancer Center Lexington KY
University of Kentucky/Markey Cancer Center Lexington KY
University of Michigan Comprehensive Cancer Center Ann Arbor MI
University of New Mexico Cancer Center Albuquerque NM
University of New Mexico Cancer Center Albuquerque NM
University of North Carolina - Chapel Hill Chapel Hill NC
University of Oklahoma Health Sciences Center Oklahoma City OK
University of Oklahoma Health Sciences Center Oklahoma City OK
University of Rochester Rochester NY
University of Texas Medical Branch Galveston TX
University of Texas Southwestern Medical School Dallas TX
University of Utah Health Science Center Salt Lake City UT
University of Washington Medical Center Seattle WA
University of Wisconsin Hospital and Clinics Madison WI
University of Wisconsin Hospital and Clinics Madison WI
University Pointe West Chester OH
University Pointe-Precision Radiotherapy West Chester OH
UPMC-Heritage Valley Health System Beaver Beaver PA
UPMC-Shadyside Hospital Pittsburgh PA
Upstate Carolina CCOP Spartanburg SC
UT Southwestern/Simmons Cancer Center-Dallas Dallas TX
Utah Cancer Specialists-Salt Lake City Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
UTMB Cancer Center at Victory Lakes League City TX
Virtua Memorial Mount Holly NJ
Virtua Voorhees Voorhees NJ
Washington University School of Medicine Saint Louis MO
Washington University School of Medicine St. Louis MO
Western Oncology Research Consortium Portland OR
Wheeling Hospital/Schiffler Cancer Center Wheeling WV
Yale University New Haven CT
Yale University New Haven CT
Yale-New Haven Hospital Saint Raphael Campus New Haven CT
Updated: 3/3/2017

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