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RTOG 0848 Protocol Information

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A Phase IIR and A Phase III Trial Evaluating Both Erlotinib (Ph IIR) And Chemoradiation (Ph III) As Adjuvant Treatment For Patients With Resected Head Of Pancreas Adenocarcinoma
Principal Investigator: Ross A. Abrams, MD
Primary Objective:

PhII-R: To determine whether the addition of erlotinib to gemcitabine adjuvant chemotherapy shows a signal for improved survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process). 

Ph III-To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine based chemotherapy further enhances survival for such patients who are without evidence of progressive disease after 5 cycles of gemcitabine based chemotherapy.

NOTE: The ph II-R erlotinib randomization (Arm 2) will be permanently closed to accrual effective April 2, 2014 and no new patients will receive erlotinib. Patients currently receiving erlotinib may continue to receive erlotinib on study at the discretion of the treating physician.

NOTE: Accrual of new patients to STEP 1 registration is not permitted until the IRB of record has reviewed and approved the CTEP approved amendment 5. STEP 2 registration remains open for patients that were enrolled prior to 5:00p.m. EST on February 28, 2014 (date the protocol was temporarily closed to accrual).

Patient Population:

Resected head of pancreas adenocarcinoma. This includes the pancreatic head, uncinate process, and neck of the pancreas, status post a curative-intent pancreaticoduodenectomy

 

Target Accrual: 950
Current Accrual: 336
Status: Open to Accrual
Date: 4/2/2014
Participating Sites:
21st Century Oncology Las Vegas NV
Abbott Northwestern Hospital Minneapolis MN
Abington Memorial Hospital Abington PA
Adams Cancer Center Gettysburg PA
Adena Regional Medical Center Chillicothe OH
Akron City Hospital Akron OH
Alta Bates Summit Medical Center - Summit Campus Oakland CA
Anderson Memorial Hospital Anderson SC
Aria Health Philadelphia PA
Barnes Jewish West County Hospital St. Louis MO
Bay Area Medical Center Marinette WI
Bay Area Tumor Institute CCOP Oakland CA
Benefis Healthcare-Sletten Cancer Institute Great Falls MT
Berkshire Medical Center Pittsfield MA
Billings Clinic Cancer Center Billings MT
Borgess Medical Center Kalamazoo MI
Boston Medical Center MBCCOP Boston MA
Bronson Methodist Hospital Kalamazoo MI
Bryn Mawr Hospital Bryn Mawr PA
California Cancer Center CGOP Fresno CA
Cancer Care Center, Inc Salem OH
Cancer Centers of the Carolinas-Andrews Greenville SC
Cancer Centers of the Carolinas-Faris Road Greenville SC
Cancer Centers of the Carolinas-Greer Radiation Oncology Greer SC
Cancer Centers of the Carolinas-Seneca Seneca SC
Cancer Centers of the Carolinas-Spartanburg Spartanburg SC
Cancer Research for the Ozarks CCOP Springfield MO
Cancer Treatment Center Wooster OH
Carle Cancer Center CCOP Urbana IL
Carolinas Medical Center/Levine Cancer Institute Charlotte NC
Center for Cancer Care @ Goshen Health System Goshen IN
Cherry Tree Cancer Center Hanover PA
Christiana Care Health Services, Inc. CCOP Newark DE
Columbus Community Clinical Oncology Program Columbus OH
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas NV
Comprehensive Cancer Ctrs of Nevada - Henderson Henderson NV
Comprehensive Cancer Ctrs of Nevada - Northwest Las Vegas NV
Comprehensive Cancer Ctrs of Nevada - Summerlin Las Vegas NV
Comprehensive Cancer Ctrs of Nevada - Sunset Las Vegas NV
Cox Health System Springfield MO
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Cancer Center East St. George UT
Doctor's Hospital Columbus OH
Door County Cancer Center Sturgeon Bay WI
East Bay Radiation Oncology Center Castro Valley CA
East Carolina Medical School Greenville NC
Elkhart General Hospital Elkhart IN
Elliot Hospital Manchester NH
Epic Care Dublin - Partners in Cancer Care Dublin CA
Epic Care Pleasant Hill - Partners in Cancer Care Pleasant Hill CA
Fairview Ridges Hospital Burnsville MN
Fairview Southdale Hospital Edina MN
Florida Hospital Orlando FL
Fox Chase Virtua Health Cancer Treatment Center Voorhees NJ
Freeman Health System Joplin MO
Geisinger Medical Center CCOP Danville PA
Geisinger Wyoming Valley Medical Center Wilkes Barre PA
Genesis Healthcare System Zainesville OH
Gibbs Cancer Center-Pelham Greer SC
Good Samaritan Health Systems Kearney NE
Grady Memorial Hospital Delaware OH
Grant Medical Center Columbus OH
Greenville CCOP - Cancer Centers of the Carolinas-Eastside Greenville SC
Gulf Coast MB-CCOP-Cancer Center at Providence Hospital Mobile AL
Hartford Hospital Hartford CT
Heartland Regional Medical Center St. Joseph MO
Hennepin County Medical Center Minneapolis MN
Henry Ford Hospital Detroit MI
Highland Hospital Rochester NY
Holy Cross Hospital Inc. Fort Lauderdale FL
Huron Valley Hospital Commerce Township MI
Ingalls Memorial Hospital Harvey IL
Intermountain Medical Center Murray UT
JC Robinson, MD Regional Cancer Center San Pablo CA
John H. Stroger, Jr. Hospital of Cook County MBCCOP Chicago IL
Jupiter Medical Center Jupiter FL
Kaiser Permanente Northern California-Oakland Oakland CA
Kaiser Permanente Northern California-South Sacramento Sacramento CA
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kalispell Regional Medical Center Kalispell MT
Kansas City CCOP Prairie Village KS
La Porte Hospital La Porte IN
LAC + USC Medical Center Los Angeles CA
Lakeland Regional Health System St. Joseph MI
Lankenau Hospital Wynnewood PA
LDS Hospital Salt Lake City UT
Legacy Good Samaritan Hospital & Medical Center Portland OR
Legacy Mount Hood Medical Center Gresham OR
Legacy Salmon Creek Hospital Vancouver WA
Liberty Radiation Oncology Clinic Liberty MO
Licking Memorial Hospital Newark OH
Logan Regional Hospital Logan UT
London Regional Cancer Program London Ontario
Loyola University Chicago Maywood IL
Maimonides Medical Center Brooklyn NY
Main Line CCOP Wynnewood PA
Maplewood Cancer Center Maplewood MN
Marietta Memorial Hospital Marietta OH
Mayo Clinic Rochester MN
Mayo Clinic in Florida Jacksonville FL
McKay-Dee Hospital Ogden UT
MD Anderson Cancer Center Orlando Orlando FL
Medical College of Wisconsin Milwaukee WI
Medical University of South Carolina Charleston SC
Memorial Hospital South Bend IN
Memorial Sloan Kettering Cancer Center (MSKCC) at Phelps Sleepy Hollow NY
Memorial Sloan Kettering of Rockville Center Rockville NY
Memorial Sloan Kettering-Basking Ridge Basking Ridge NJ
Memorial Sloan-Kettering Cancer Center New York NY
Memorial Sloan-Kettering Cancer Center at Commack Commack NY
Menorah Medical Center Overland Park KS
Mercy Hospital Coon Rapids MN
Mercy Hospital St. Louis St Louis MO
Mercy Hospital-Joplin Joplin MO
Mercy-Springfield Springfield MO
Methodist Cancer Center Omaha NE
Methodist Medical Center of Illinois Peoria IL
Metro-MN CCOP St. Louis Park MN
Michiana Hematology-Oncology, P.C. Mishawaka IN
Mid Ohio Oncology Hematology Inc- Mark H. Zangmeister Ctr Cols OH
Montana Cancer Consortium CCOP Billings MT
Mount Carmel Medical Center-State Street Columbus OH
Mount Carmel-St. Ann's Cancer Center Westerville OH
Mount Sinai Comprehensive Cancer Center CCOP Miami Beach FL
Nevada Cancer Research Foundation CCOP Las Vegas NV
Newark Beth Israel Medical Center Newark NJ
North Kansas City Hospital North Kansas City MO
North Main Radiation Oncology Providence RI
North Memorial Medical Center Robbinsdale MN
Northeast Georgia Medical Center Gainesville GA
Northeast Radiation Oncology Center Dunmore PA
Northern Indiana Cancer Research Consortium CCOP South Bend IN
Northwest Community Hospital Arlington Heights IL
Ochsner Clinic CCOP New Orleans LA
Paoli Memorial Hospital Paoli PA
Peninsula Regional Medical Center Salisbury MD
Phelps County Regional Medical Center Rolla MO
Poudre Valley Hospital Radiation Oncology Fort Collins CO
Presbyterian Hospital Charlotte NC
Rabin Medical Center-Davidoff Cancer Center Petah Tikva
Radiation Oncology Center Alliance OH
Radiation Oncology Centers of Las Vegas Las Vegas NV
Reading Hospital Reading PA
Regions Radiation Therapy St. Paul MN
Renown Regional Medical Center Reno NV
Research Medical Center Kansas City MO
Rex Cancer Center Raleigh NC
Rhode Island Hospital Providence RI
Rice Memorial Hospital Willmar MN
Ridgeview Medical Center Waconia MN
Riverside Methodist Hospital Columbus OH
Rocky Mountain Oncology Center Casper WY
Rush-Copley Medical Center Aurora IL
Rutherford Hospital Inc. Rutherfordton NC
Saint Barnabas Medical Center Livingston NJ
Saint John's Hospital - HealthEast Maplewood MN
Saint Joseph Regional Medical Center - Mishawaka Mishawaka IN
Sands Cancer Center Canandaigua NY
Sentara Cancer Institute at Sentara CarePlex Hospital Hampton VA
Sentara Norfolk General Hospital Norfolk VA
Sentara Virginia Beach General Hospital Virginia Beach VA
Sheba Medical Center Tel Hashomer
Sinai Hospital of Baltimore Baltimore MD
Siteman Cancer Center - South County St Louis MO
Siteman Cancer Center/Barnes Jewish St. Peters Hospital St. Peters MO
Southern Ohio Medical Center - Cancer Center Portsmouth OH
Sparta Cancer Center Sparta NJ
Spartanburg Regional Medical Center Spartanburg SC
Springfield Regional Medical Center Springfield OH
St Francis Regional Med Cntr Wichita KS
St Johns Hospital, Cancer Institute Springfield IL
St Luke's Hospital Kansas City MO
St. Agnes Healthcare Baltimore MD
St. Francis Hospital Federal Way WA
St. Luke's Mountain States Tumor Institute Boise ID
St. Luke's Mountain States Tumor Institute (MSTI) Twin Falls Twin Falls ID
St. Mary's Hospital Medical Center Green Bay WI
St. Vincent Regional Cancer Center CCOP Green Bay WI
Summa Health Center at Lake Medina Medina OH
Summa Health System Barberton Hospital Barberton OH
Tel-Aviv Sourasky Medical Center Tel-Aviv
Texas Oncology - Austin Midtown Austin TX
Texas Oncology - Central South Austin Austin TX
Texas Oncology - Round Rock Cancer Center Round Rock TX
Texas Oncology - Seton Williamson Round Rock TX
Texas Oncology - South Austin Austin TX
The Hospital of Central Connecticut New Britain CT
The Ottawa Hospital Regional Cancer Centre Ottawa, Ontario
The Regional Cancer Center at Singing River Hospital System Pascagoula MS
Thomas Jefferson University Hospital Philadelphia PA
Tulane University Medical Center New Orleans LA
UCSD – University of California, San Diego LaJolla CA
UMDNJ-New Jersey Medical School Newark NJ
United Hospital St. Paul MN
Unity Hospital Fridley MN
Univ. of Miami Sylvester Comp Cancer Ctr-Deerfield Beach Deerfield Beach FL
University of California, Irvine Orange CA
University of Kentucky Hospital Lexington KY
University of Maryland Medical Systems Baltimore MD
University of Miami Miller School of Medicine Miami FL
University of Michigan Medical Center Ann Arbor MI
University of Mississippi Medical Center Jackson MS
University of Oklahoma Health Sciences Center Oklahoma City OK
University of Rochester Rochester NY
University of Southern California Los Angeles CA
University of Texas Medical Branch Galveston TX
University of Utah Health Science Center Salt Lake City UT
Upstate Carolina CCOP - Gibbs Regional Cancer Center Spartanburg SC
USON- New York Oncology Hematology, P.C. Albany NY
USON- Texas Oncology Arlington South Arlington TX
USON- Texas Oncology Longview Cancer Center Longview TX
USON- Texas Oncology-PA Bedford Bedford TX
USON- Texas Oncology-Sugar Land Sugarland TX
USON- Texas Oncology-Tyler Tyler TX
USON-Cancer Care Northwest - Spokane Spokane WA
USON-Cancer Care Northwest-East Holland Spokane WA
USON-Fort Worth Fort Worth TX
USON-Texas Oncology - Houston Memorial City Houston TX
USON-Texas Oncology- Sherman Sherman TX
USON-Texas Oncology-Lewisville Flower Mound TX
Utah Cancer Specialists Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
Valley Medical Oncology Consultants Pleasanton CA
Virtua-Memorial Hospital Burlington County, Inc. Mount Holly NJ
Washington University St. Louis MO
Wayne State University-Karmanos Cancer Institute Detroit MI
Weisberg Cancer Treatment Center Farmington Hills MI
Welch Cancer Center Sheridan WY
Winthrop University Hospital Mineola NY
York Cancer Center York PA
Updated: 4/2/2014

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