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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: 350
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
ACR Clinical Research Center Philadelphia PA
Adams Cancer Center Gettysburg PA
Adena Regional Medical Center Chillicothe OH
Adventist Medical Center Portland OR
Akron City Hospital Akron OH
Akron General Medical Center Akron OH
Albert Einstein Medical Center Philadelphia PA
Allegheny General Hospital Pittsburgh PA
Allegheny Valley Hospital Natrona Heights PA
Alta Bates Hospital Comprehensive Cancer Center Berkeley CA
Alta Bates Summit Medical Center - Summit Campus Oakland CA
Anderson Memorial Hospital Anderson SC
Aria Health Philadelphia PA
Atrium Medical Center-Middletown Regional Hospital Franklin OH
Auburn Radiation Oncology Center Auburn CA
Barnes Jewish West County Hospital St. Louis MO
Barnes-Jewish West County Hospital Saint Louis MO
Bay Area Medical Center Marinette WI
Bay Area Medical Center Marinette WI
Bay Area Tumor Institute CCOP Oakland CA
Bay Medical Center Panama City FL
Bellin Memorial Hospital, Inc. Green Bay WI
Benefis Healthcare- Sletten Cancer Institute Great Falls MT
Benefis Healthcare-Sletten Cancer Institute Great Falls MT
Berkshire Medical Center Pittsfield MA
Billings Clinic Cancer Center Billings MT
Bixby Medical Center Adrian MI
Bixby Medical Center Adrian MI
Blanchard Valley Regional Health Center Findlay OH
Borgess Medical Center Kalamazoo MI
Boston Medical Center Boston MA
Boston Medical Center MBCCOP Boston MA
Boulder Community Hospital Boulder CO
Bozeman Deaconess Hospital Cancer Center Bozeman MT
Brigham and Women's Hospital/Dana Farber Cancer Institute Boston MA
Bronson Methodist Hospital Kalamazoo MI
Bryn Mawr Hospital Bryn Mawr PA
California Cancer Center CGOP Fresno CA
California Pacific Medical Center San Francisco CA
Cancer Care Center, Inc Salem OH
Cancer Research for the Ozarks CCOP Springfield MO
Cancer Treatment Center Wooster OH
Carle Cancer Center CCOP Urbana IL
Carolina Medical Center-Northeast Concord NC
Carolinas Medical Center/Levine Cancer Institute Charlotte NC
Carolinas Medical Center-Union Monroe NC
Center for Cancer Care @ Goshen Health System Goshen IN
Central Baptist Hospital Lexington KY
Centre Hospitalier de l`Université de Montréal-Notre Dame Montreal Quebec
Cherry Tree Cancer Center Hanover PA
Christiana Care Health Services, Inc. CCOP Newark DE
City of Hope Duarte CA
City of Hope Medical Center Duarte CA
Clackamas Radiation Oncology Center Clackamas OR
Columbia River CCOP Portland OR
Columbus Community Clinical Oncology Program Columbus OH
Community Cancer Center Normal IL
Community Howard Regional Health Kokomo IN
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
Dayton CCOP Kettering OH
Delaware County Memorial Hospital Drexel Hill PA
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Cancer Center East St. George UT
Doctors Hospital Columbus OH
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
East Carolina Medical School Greenville NC
Elkhart General Hospital Elkhart IN
Elliot Hospital Manchester NH
Emory University Atlanta GA
Emory University Hospital Midtown Atlanta GA
Epic Care Dublin - Partners in Cancer Care Dublin CA
Epic Care Pleasant Hill - Partners in Cancer Care Pleasant Hill CA
Exempla Lutheran Medical Center Wheat Ridge CO
Fairview Ridges Hospital Burnsville MN
Fairview Southdale Hospital Edina MN
Florida Hospital Orlando FL
Flower Hospital Sylvania OH
Fox Chase Virtua Health Cancer Treatment Center Voorhees NJ
Franciscan St. Francis Health-Beech Grove Beech Grove IN
Freeman Health System Joplin MO
Geisinger Medical Center Danville PA
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
Good Samaritan Hospital Dayton OH
Grady Health System Atlanta GA
Grady Memorial Hospital Delaware OH
Grady Memorial Hospital Atlanta GA
Grandview Hospital & Medical Center Dayton OH
Grant Medical Center Columbus OH
Grant Medical Center Columbus OH
Great Falls Clinic Great Falls MT
Green Bay Oncology - Oconto Falls Oconto Falls WI
Green Bay Oncology at St. Vincent Hospital Green Bay WI
Greene Memorial Hospital Xenia OH
Greenville Health System Cancer Institute-Andrews Greenville SC
Greenville Health System Cancer Institute-Faris Greenville SC
Greenville Health System Cancer Institute-Faris Greenville SC
Greenville Health System Cancer Institute-Greer Radiation Greer SC
Greenville Health System Cancer Institute-International Greenville SC
Greenville Health System Cancer Institute-Seneca Seneca SC
Greenville Health System Cancer Institute-Spartanburg Spartanburg SC
Gulf Coast MB-CCOP-Cancer Center at Providence Hospital Mobile AL
Gunderson Clinic La Crosse WI
Hartford Hospital Hartford CT
Heartland Regional Medical Center St. Joseph MO
Hennepin County Medical Center Minneapolis MN
Hennepin County Medical Center Minneapolis MN
Henry Ford Hospital Detroit MI
Henry Ford Macomb Hospital Clinton Township MI
Highland Clinic Shreveport LA
Highland Hospital Rochester NY
Holy Cross Hospital Inc. Fort Lauderdale FL
Huron Valley Hospital Commerce Township MI
Illinois Oncology Research Association CCOP Peoria IL
Image-Guided Therapy QA Center (ITC) St. Louis MO
Ingalls Memorial Hospital Harvey IL
Ingalls Memorial Hospital Harvey IL
Intercommunity Cancer Center Monroeville PA
Intermountain Medical Center Murray UT
JC Robinson, MD Regional Cancer Center San Pablo CA
John H Stroger Jr Hospital of Cook County Chicago IL
John H. Stroger, Jr. Hospital of Cook County MBCCOP Chicago IL
Jupiter Medical Center Jupiter FL
Kaiser Permanent Northern California-Rancho Cordova Rancho Cordova CA
Kaiser Permanente - Sacramento Sacramento CA
Kaiser Permanente Cancer Treatment Center South San Francisco CA
Kaiser Permanente Northern California Santa Clara CA
Kaiser Permanente Northern California-Oakland Oakland CA
Kaiser Permanente Northern California-Rohnert Park Rohnert Park CA
Kaiser Permanente Northern California-Roseville Roseville CA
Kaiser Permanente Northern California-South Sacramento Sacramento CA
Kaiser Permanente Northern California-South San Francisco South San Francisco CA
Kaiser Permanente Oakland-Broadway Oakland CA
Kaiser Permanente-Santa Rosa Santa Rosa CA
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kalispell Regional Medical Center Kalispell MT
Kalispell Regional Medical Center Kalispell MT
Kansas City CCOP Prairie Village KS
Kettering Medical Center Dayton OH
Kinston Medical Specialists PA Kinston NC
La Porte Hospital La Porte IN
LAC + USC Medical Center Los Angeles CA
Lakeland Regional Health System St. Joseph MI
Langlade Hospital Cancer Center Antigo WI
Lankenau Hospital Wynnewood PA
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
Legacy Salmon Creek Hospital Vancouver WA
Levine Cancer Institute-Pineville Charlotte NC
Lewis Cancer & Research Pavilion at St. Joseph's/Candler Savannah GA
Lewis Cancer & Research Pavilion-Hilton Head/Blufton Hilton Head Island SC
Liberty Radiation Oncology Clinic Liberty MO
Licking Memorial Hospital Newark OH
Lima Memorial Hospital Lima OH
Lima Memorial Hospital Lima OH
Logan Regional Hospital Logan UT
London Regional Cancer Program London Ontario
London Regional Cancer Program London
Long Island Jewish Hospital Lake Success NY
Long Island Jewish Medical Center New Hyde Park NY
Los Angeles County-USC Medical Center Los Angeles CA
Loyola University Chicago Maywood IL
Loyola University Medical Center Maywood IL
M.D. Anderson Cancer Center Orlando Orlando FL
Maimonides Medical Center Brooklyn NY
Main Line CCOP Wynnewood PA
Maplewood Cancer Center Maplewood MN
Marietta Memorial Hospital Marietta OH
Marshall Radiation Oncology Center Cameron Park CA
Massachusetts General Hospital Boston MA
Mayo Clinic Rochester MN
Mayo Clinic Rochester MN
Mayo Clinic Arizona Phoenix AZ
Mayo Clinic in Arizona Scottsdale AZ
Mayo Clinic in Florida Jacksonville FL
McGill University Montreal
McKay-Dee Hospital Ogden UT
MD Anderson Cancer Center Orlando Orlando FL
Medical College of Wisconsin Milwaukee WI
Medical University of Ohio Toledo OH
Medical University of South Carolina Charleston SC
Memorial Hospital South Bend IN
Memorial Medical Center Savannah GA
Memorial Sloan Kettering Cancer Center New York NY
Memorial Sloan Kettering Cancer Center (MSKCC) at Phelps Sleepy Hollow NY
Memorial Sloan Kettering Cancer Center Commack Commack 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 Cancer Center Elyria OH
Mercy Cancer Center at St. Ann Toledo OH
Mercy Catholic Medical Center - Fitzgerald Darby PA
Mercy General Radiation Oncology Center Sacramento CA
Mercy Hospital Coon Rapids MN
Mercy Hospital St. Louis St Louis MO
Mercy Hospital-Joplin Joplin MO
Mercy San Juan Radiation Oncology Center Carmichael CA
Mercy-Springfield Springfield MO
Methodist Cancer Center Omaha NE
Methodist Hospital Philadelphia PA
Methodist Medical Center of Illinois Peoria IL
MetroHealth Medical Center Cleveland OH
Metro-MN CCOP St. Louis Park MN
Miami Valley Hospital Dayton OH
Michiana Hematology-Oncology, P.C. Mishawaka IN
Mid Ohio Oncology Hematology Inc- Mark H. Zangmeister Ctr Cols OH
Mills-Peninsula Health Services San Mateo CA
Montana Cancer Consortium CCOP Billings MT
Mount Carmel Medical Center-Broad Street Columbus OH
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
Nevada Cancer Research Foundation CCOP Las Vegas NV
New York University Hospital New York NY
New York University Langone Medical Center New York NY
Newark Beth Israel Medical Center Newark NJ
North Coast Cancer Care Sandusky OH
North Kansas City Hospital North Kansas City MO
North Main Radiation Oncology Providence RI
North Memorial Medical Center Robbinsdale MN
North Shore University Hospital CCOP Manhasset NY
Northeast Georgia Medical Center Gainesville GA
Northeast Radiation Oncology Center Dunmore PA
Northern Indiana Cancer Research Consortium CCOP South Bend IN
Northern Rockies Radiation Oncology Center Billings MT
Northwest Cancer Specialists-Vancouver Vancouver WA
Northwest Community Hospital Arlington Heights IL
Northwestern Memorial Hospital Chicago IL
Ochsner Clinic CCOP New Orleans LA
Orange Regional Medical Center Middletown NY
OSF Saint Francis Medical Center Radiation Oncology Peoria IL
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Springfield MO
Pacific Cancer Institute Wailuku HI
Palo Alto Medical Foundation Palo Alto CA
Paoli Memorial Hospital Paoli PA
Parkridge University Radiation Oncology Rochester NY
PeaceHealth Southwest Medical Center Vancouver WA
Pekin Cancer Treatment Center Pekin IL
Peninsula Regional Medical Center Salisbury MD
Pennsylvania Hospital Philadelphia PA
Penrose Cancer Center, Penrose-St. Francis Health Services Colorado Springs CO
Phelps County Regional Medical Center Rolla MO
Poudre Valley Hospital Radiation Oncology Fort Collins CO
Presbyterian Hospital Charlotte NC
Presbyterian Hospital Charlotte NC
Presbyterian Intercommunity Hospital Whittier CA
Providence Milwaukie Hospital Milwaukie OR
Providence Portland Medical Center Portland OR
Providence Portland Medical Center Portland OR
Providence Saint Vincent Medical Center Portland OR
Providence St. Joseph Medical Center - Disney Family CA Ctr Burbank CA
Providence St. Vincent Medical Center Portland OR
Queen's Medical Center Honolulu HI
Rabin Medical Center Petach Tikva
Rabin Medical Center-Davidoff Cancer Center Petah Tikva
Radiation Oncology Associates Incorporated Providence RI
Radiation Oncology Center Alliance OH
Radiation Oncology Centers of Las Vegas Las Vegas NV
Radiation Oncology of Northern Illinois Ottawa IL
Radiological Associates of Sacramento Sacramento CA
Radiological Physics Center (RPC) Houston TX
Rapid City Regional Hospital Rapid City SD
Reading Hospital West Reading PA
Reading Hospital Reading PA
Regions Radiation Therapy St. Paul MN
Reid Hospital & Health Care Services Richmond IN
Renown Regional Medical Center Reno NV
Research Medical Center Kansas City MO
Rex Cancer Center Raleigh NC
Rhode Island Hospital Providence RI
Rhode Island Hospital Providence RI
Rice Memorial Hospital Willmar MN
Riddle Memorial Hospital Media PA
Ridgeview Medical Center Waconia MN
Riverside Methodist Hospital Columbus OH
Robinson Radiation Oncology Ravenna OH
Rock Hill Radiation Therapy Center Rock HIll SC
Rocky Mountain Oncology Casper WY
Rocky Mountain Oncology Center Casper WY
Rose Medical Center Denver CO
Roseville Radiation Oncology Center Roseville CA
Rush University Medical Center Chicago IL
Rush-Copley Medical Center Aurora IL
Rutgers, The State University of New Jersey New Brunswick NJ
Rutherford Hospital Inc. Rutherfordton NC
Saint Agnes Medical Center Fresno CA
Saint Barnabas Medical Center Livingston NJ
Saint Francis Medical Center Peoria IL
Saint John's Hospital - HealthEast Maplewood MN
Saint Joseph Regional Medical Center - Mishawaka Mishawaka IN
Saint Luke's Mountain States Tumor Institute Boise ID
Saint Vincent Mercy Medical Center Toledo OH
Sandra L. Maxwell Cancer Center Cedar City UT
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
Siteman Cancer Center-South County Saint Louis MO
Solano Radiation Oncology Center Vacaville CA
South Sacramento Cancer Center Sacramento CA
Southern Ohio Medical Center - Cancer Center Portsmouth OH
Southside Hospital Bayshore NY
Sparta Cancer Center Sparta NJ
Sparta Cancer Center Sparta NJ
Spartanburg Regional Medical Center Spartanburg SC
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 Mary's Hospital & Medical Center Grand Junction CO
St. Agnes Healthcare Baltimore MD
St. Anthony's Health Alton IL
St. Charles Mercy Hospital Oregon OH
St. Francis Hospital Federal Way WA
St. Joseph Hospital Orange CA
St. Louis University Hospital St. Louis MO
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
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville CA
Sutter Health Western Division Cancer Research Group Novato CA
Sutter Solano Medical Center Vallejo CA
Swedish Medical Center Englewood CO
Tel Aviv Sourasky Medical Center Tel Aviv
Tel-Aviv Sourasky Medical Center Tel-Aviv
Texas Cancer Center-Sherman Sherman TX
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 Cancer Center of Hawaii-Leeward Ewa Beach HI
The Cancer Center of Hawaii-Liliha Honolulu HI
The Hospital of Central Connecticut New Britain CT
The Mark H Zangmeister Center Columbus OH
The Ottawa Hospital Regional Cancer Centre Ottawa, Ontario
The Permanente Medical Group-Roseville Radiation Oncology Roseville CA
The Queen's Medical Center Honolulu HI
The Regional Cancer Center at Singing River Hospital System Pascagoula MS
The Schiffler Cancer Center Wheeling WV
Thomas Jefferson University Hospital Philadelphia PA
Thomas Jefferson University Hospital Philadelphia PA
Toledo Clinic Cancer Centers - Adrian Adrian MI
Toledo Clinic Cancer Centers - Maumee Maumee OH
Toledo Community Hospital Oncology Program CCOP Toledo OH
Toledo Community Hospital Oncology Program CCOP Toledo OH
Tulane University Health Sciences Center New Orleans LA
Tulane University Medical Center New Orleans LA
Tyler Cancer Center Tyler TX
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 Chicago Chicago IL
University of Chicago Chicago IL
University of Cincinnati Cincinnati OH
University of Hawaii Cancer Research Center MBCCOP Honolulu HI
University of Illinois Chicago IL
University of Illinois at Chicago Chicago IL
University of Kentucky Hospital Lexington KY
University of Maryland Medical Systems Baltimore MD
University of Maryland/Greenebaum Cancer Center Baltimore MD
University of Miami Miller School of Medicine Miami FL
University of Miami Miller School of Medicine-Sylvester Cancer Center 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 Oklahoma Health Sciences Center Oklahoma City OK
University of Rochester Rochester NY
University of Rochester Rochester NY
University of Southern California Los Angeles CA
University of Texas Medical Branch Galveston TX
University of Texas-MD Anderson Cancer Center Houston TX
University of Utah Health Science Center Salt Lake City UT
University Pointe-Precision Radiotherapy West Chester OH
Upper Valley Medical Center Troy OH
Upstate Carolina CCOP - Gibbs Regional Cancer Center Spartanburg SC
USON- Cancer Care Centers of South Texas-NE San Antonio TX
USON- New York Oncology Hematology, P.C. Albany NY
USON- Northwest Cancer Specialist-Portland Portland OR
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
Utah Valley Regional Medical Center Provo UT
Valley Medical Oncology Consultants Pleasanton CA
Virtua-Memorial Hospital Burlington County, Inc. Mount Holly NJ
Warren Cancer Research Foundation-Oklahoma CCOP Tulsa OK
Washington Cancer Institute Washington DC
Washington University St. Louis MO
Wausau Hospital Center Wausau WI
Wayne State University-Karmanos Cancer Institute Detroit MI
Weisberg Cancer Treatment Center Farmington Hills MI
Welch Cancer Center Sheridan WY
William W. Backus Hospital Norwich CT
Winthrop University Hospital Mineola NY
York Cancer Center York PA
Updated: 4/2/2014

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