Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, adenocarcinoma of the pancreas
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the pancreas Locally advanced or regional (encompassable within the same radiotherapy portals) Adenosquamous cancers are allowed Unresectable disease Measurable and/or non-measurable disease as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI), which must be performed within 4 weeks prior to randomization. Age>=18 ECOG Performance status of 0-1 Life expectancy >= 12 weeks Adequate bone marrow reserve,liver and renal function within 2 weeks of randomization: Absolute granulocyte count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis) Serum glutamic-oxaloacetic (AST) less than 5 times upper limit of normal (ULN) Albumin greater than 2.5 g/dL Creatinine no greater than 1.5 times ULN Fertile patients must use effective contraception Willing and able to attend follow-up visits Concurrent enrollment on protocol ECOG-E1Y03 allowed More than 4 weeks since prior investigational agents Exclusion Criteria: Candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0) Stage M1 disease Small cell, mucinous cystadenocarcinoma, islet cell or papillary cystic histology Pregnant or nursing Active infection within within 4 weeks of randomization Malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score no greater than 7) History of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma) Signs or symptoms of peptic or duodenal ulcer disease Concurrent serious systemic disorders that are incompatible with study participation Prior chemotherapy for pancreatic cancer Prior radiotherapy Concurrent intensity modulated radiotherapy
Sites / Locations
- Banner Good Samaritan Medical Center
- Saint Joseph's Mercy Cancer Center
- California Cancer Center - Woodward Park Office
- Doctors Medical Center
- Memorial Medical Center Cancer Services
- North Colorado Medical Center
- McKee Medical Center
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- New Britain General Hospital
- Yale Comprehensive Cancer Center at Yale University School of Medicine
- William W. Backus Hospital
- Halifax Medical Center
- University of Florida Shands Cancer Center
- Baptist Cancer Institute - Jacksonville
- Mayo Clinic - Jacksonville
- Emory University Hospital - Atlanta
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Northeast Georgia Medical Center
- Cancer Care and Research Pavilion at St. Joseph's/Candler
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Hematology and Oncology Associates
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Mercy Hospital and Medical Center
- Swedish Covenant Hospital
- St. Anthony's Memorial Hospital
- Eureka Community Hospital
- Evanston Northwestern Health Care - Evanston Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- InterCommunity Cancer Center of Western Illinois
- Mason District Hospital
- Hinsdale Hematology Oncology Associates
- Hopedale Medical Complex
- Midwest Center for Hematology/Oncology
- Joliet Oncology Hematology Associates, Limited - West
- Provena St. Mary's Wasser Regional Cancer Center - Kankakee
- Kewanee Hospital
- La Grange Memorial Hospital
- Deerpath Medical Associates
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- McDonough District Hospital
- Northwest Medical Specialist, PC
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Cancer Treatment Center at Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology/Hematology Associates of Central Illinois, P.C.
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- Swedish American Hospital
- Hematology Oncology Associates - Skokie
- Hematology/Oncology of the North Shore at Gross Point Medical Center
- Midwest Cancer Research Group, Incorporated
- St. Margaret's Hospital
- Valley Cancer Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology
- Indiana University Cancer Center
- William N. Wishard Memorial Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- McFarland Clinic, P.C.
- Genesis Regional Cancer Center at Genesis Medical Center
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- Burgess Health Center
- Ottumwa Regional Health Center Cancer Center
- Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Central Baptist Hospital
- Baton Rouge General Regional Cancer Center
- Mary Bird Perkins Cancer Center - Baton Rouge
- MBCCOP - LSU Health Sciences Center
- Medical Center of Louisiana - New Orleans
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Tufts - New England Medical Center
- Hickman Cancer Center at Bixby Medical Center
- Green Bay Oncology, Limited - Escanaba
- Green Bay Oncology, Limited - Iron Mountain
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
- Mercy Memorial Hospital System
- William Beaumont Hospital - Royal Oak Campus
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- CCOP - Duluth
- Miller-Dwan Medical Center
- St. Mary's - Duluth Clinic Cancer Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- Mayo Clinic Cancer Center
- CentraCare Clinic - River Campus
- CCOP - Metro-Minnesota
- Park Nicollet Health Services
- United Hospital
- Ridgeview Medical Center
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Great Falls Clinic
- Good Samaritan Health Systems
- Bryan LGH Medical Center West
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Methodist Cancer Center at Methodist Hospital - Omaha
- Immanuel Medical Center
- Bergan Mercy Medical Center
- Creighton University Medical Center
- Midlands Cancer Center at Midlands Community Hospital
- CCOP - Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - East Orange
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
- Fox Chase Virtua Health Cancer Program - Marlton
- Booker Cancer Center at Riverview Medical Center
- Shore Memorial Hospital - Somers Point
- Community Regional Cancer Center at Community Medical Center
- Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
- Wayne Memorial Hospital, Incorporated
- Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
- Zimmer Cancer Center at New Hanover Regional Medical Center
- Wilson Medical Center
- Forsyth Regional Cancer Center at Forsyth Medical Center
- Bismarck Cancer Center
- Cancer Care Center at Medcenter One Hospital
- Mid Dakota Clinic, P.C.
- St. Alexius Medical Center
- Trinity Cancer Care Center
- St. Elizabeth Boardman Cancer Center
- University Hospitals Ireland Cancer Center at Mercy Medical Center
- Aultman Hospital Cancer Center at Aultman Health Foundation
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
- Blanchard Valley Medical Associates
- Fremont Memorial Hospital
- St. Rita's Medical Center
- Lima Memorial Hospital
- St. Luke's Hospital
- St. Charles Mercy Hospital
- Firelands Regional Medical Center
- Promedica Cancer Center at Flower Hospital
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical College of Ohio Cancer Institute
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- St. Joseph Health Care Center
- Fulton County Health Center
- St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Bryn Mawr Hospital
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Lancaster General Hospital
- Lewistown Hospital
- Paoli Memorial Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Albert Einstein Cancer Center
- Phoenixville Hospital
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
- Veterans Affairs Medical Center - Pittsburgh
- St. Joseph Medical Center
- Guthrie Medical Center - Sayre
- Hematology and Oncology Associates
- Mount Nittany Medical Center
- Chester County Hospital
- Jennersville Regional Hospital
- Reading Hospital and Medical Center
- CCOP - MainLine Health
- Lankenau Cancer Center at Lankenau Hospital
- Sioux Valley Hospital and University of South Dakota Medical Center
- Avera McKennan Hospital and University Health Center
- Medical X-Ray Center, P. C.
- Thompson Cancer Survival Center
- Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
- Doctor's Hospital of Laredo
- Joe Arrington Cancer Research and Treatment Center
- East Texas Medical Center Cancer Institute
- Cottonwood Hospital Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center
- Utah Cancer Specialists at UCS Cancer Center
- LDS Hospital
- Martha Jefferson Hospital Cancer Care Center
- Bon Secours Cancer Care at St. Mary's Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
- Marshall University Medical Center
- Central Wisconsin Cancer Program at Agnesian HealthCare
- Green Bay Oncology, Limited at St. Vincent Hospital
- St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- Cancer Care Center at Holy Family Memorial Medical Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Marshfield Clinic - Marshfield Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
- University of Wisconsin Cancer Center at Aspirus Wausau Hospital
- Pretoria Academic Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Gemcitabine
Gemcitabine + Radiation