Clinical trial NCT00057876: Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer
Official title: A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: stage III pancreatic cancer
adenocarcinoma of the pancreas
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Radiation Therapy Oncology Group
First posted: 2003-04-09
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

Detailed description: OBJECTIVES:

* Compare the overall survival and progression-free of patients with locally advanced, unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy.
* Compare the objective response rate in patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Compare the quality of life (QOL) of patients treated with these regimens.
* Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs. 1) and weight loss within the past 6 months (less than 10% vs. 10% or more). Patients are randomized to 1 of 2 treatment arms.

Arm I (Gemcitabine alone):

* Induction: Patients receive gemcitabine intravenously (IV) over 30-60 minutes once weekly for 6 weeks followed by 1 week of rest.
* Consolidation: After the 1 week of rest, patients receive gemcitabine IV once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Arm II (Gemcitabine with radiotherapy):

* Induction: Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks beginning on day 1. Patients also undergo concurrent radiotherapy 5 days a week for 5.5 weeks beginning on day 1.
* Consolidation: Approximately 4 weeks after completion of radiotherapy, patients receive gemcitabine IV over 30-60 minutes once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, week 6, week 15 (for arm II), week 16 (for arm I), and 9 months.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year. Patients who receive treatment beyond 3 years are followed for survival.

ACCRUAL: 74 patients were accrued for this study.

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

Primary outcomes:
measure: Overall Survival Time
timeFrame: assessed every 3 months for 2 years, then every 6 months for year 3
Secondary outcomes:
measure: Progression-free Survival Time
timeFrame: assessed every 3 months for 2 years, then every 6 months for year 3
measure: Overall Response
timeFrame: assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Hot Springs
country: United States
facility: Saint Joseph's Mercy Cancer Center
state: Arkansas
city: Fresno
country: United States
facility: California Cancer Center - Woodward Park Office
state: California
city: Modesto
country: United States
facility: Doctors Medical Center
state: California
city: Modesto
country: United States
facility: Memorial Medical Center Cancer Services
state: California
city: Greeley
country: United States
facility: North Colorado Medical Center
state: Colorado
city: Loveland
country: United States
facility: McKee Medical Center
state: Colorado
city: Farmington
country: United States
facility: Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
state: Connecticut
city: New Britain
country: United States
facility: New Britain General Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale Comprehensive Cancer Center at Yale University School of Medicine
state: Connecticut
city: Norwich
country: United States
facility: William W. Backus Hospital
state: Connecticut
city: Daytona Beach
country: United States
facility: Halifax Medical Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida Shands Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute - Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Decatur
country: United States
facility: Veterans Affairs Medical Center - Atlanta (Decatur)
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Savannah
country: United States
facility: Cancer Care and Research Pavilion at St. Joseph's/Candler
state: Georgia
city: Valdosta
country: United States
facility: Pearlman Comprehensive Cancer Center at South Georgia Medical Center
state: Georgia
city: Aurora
country: United States
facility: Rush-Copley Cancer Care Center
state: Illinois
city: Bloomington
country: United States
facility: St. Joseph Medical Center
state: Illinois
city: Canton
country: United States
facility: Graham Hospital
state: Illinois
city: Carthage
country: United States
facility: Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Hematology and Oncology Associates
state: Illinois
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Mercy Hospital and Medical Center
state: Illinois
city: Chicago
country: United States
facility: Swedish Covenant Hospital
state: Illinois
city: Effingham
country: United States
facility: St. Anthony's Memorial Hospital
state: Illinois
city: Eureka
country: United States
facility: Eureka Community Hospital
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Health Care - Evanston Hospital
state: Illinois
city: Galesburg
country: United States
facility: Galesburg Clinic
state: Illinois
city: Galesburg
country: United States
facility: Galesburg Cottage Hospital
state: Illinois
city: Galesburg
country: United States
facility: InterCommunity Cancer Center of Western Illinois
state: Illinois
city: Havana
country: United States
facility: Mason District Hospital
state: Illinois
city: Hinsdale
country: United States
facility: Hinsdale Hematology Oncology Associates
state: Illinois
city: Hopedale
country: United States
facility: Hopedale Medical Complex
state: Illinois
city: Joliet
country: United States
facility: Midwest Center for Hematology/Oncology
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology Hematology Associates, Limited - West
state: Illinois
city: Kankakee
country: United States
facility: Provena St. Mary's Wasser Regional Cancer Center - Kankakee
state: Illinois
city: Kewanee
country: United States
facility: Kewanee Hospital
state: Illinois
city: La Grange
country: United States
facility: La Grange Memorial Hospital
state: Illinois
city: Lake Forest
country: United States
facility: Deerpath Medical Associates
state: Illinois
city: Libertyville
country: United States
facility: North Shore Oncology and Hematology Associates, Limited - Libertyville
state: Illinois
city: Macomb
country: United States
facility: McDonough District Hospital
state: Illinois
city: Niles
country: United States
facility: Northwest Medical Specialist, PC
state: Illinois
city: Normal
country: United States
facility: BroMenn Regional Medical Center
state: Illinois
city: Normal
country: United States
facility: Community Cancer Center
state: Illinois
city: Ottawa
country: United States
facility: Community Hospital of Ottawa
state: Illinois
city: Pekin
country: United States
facility: Cancer Treatment Center at Pekin Hospital
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Peoria
country: United States
facility: Proctor Hospital
state: Illinois
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Peoria
country: United States
facility: Oncology/Hematology Associates of Central Illinois, P.C.
state: Illinois
city: Peoria
country: United States
facility: OSF St. Francis Medical Center
state: Illinois
city: Peru
country: United States
facility: Illinois Valley Community Hospital
state: Illinois
city: Princeton
country: United States
facility: Perry Memorial Hospital
state: Illinois
city: Rockford
country: United States
facility: Swedish American Hospital
state: Illinois
city: Skokie
country: United States
facility: Hematology Oncology Associates - Skokie
state: Illinois
city: Skokie
country: United States
facility: Hematology/Oncology of the North Shore at Gross Point Medical Center
state: Illinois
city: Skokie
country: United States
facility: Midwest Cancer Research Group, Incorporated
state: Illinois
city: Spring Valley
country: United States
facility: St. Margaret's Hospital
state: Illinois
city: Spring Valley
country: United States
facility: Valley Cancer Center
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center at Carle Foundation Hospital
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Elkhart
country: United States
facility: Elkhart General Hospital
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: William N. Wishard Memorial Hospital
state: Indiana
city: La Porte
country: United States
facility: Center for Cancer Therapy at LaPorte Hospital and Health Services
state: Indiana
city: Michigan City
country: United States
facility: Saint Anthony Memorial Health Centers
state: Indiana
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: South Bend
country: United States
facility: Saint Joseph Regional Medical Center
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic, P.C.
state: Iowa
city: Davenport
country: United States
facility: Genesis Regional Cancer Center at Genesis Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Mercy Capitol Hospital
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Des Moines
country: United States
facility: John Stoddard Cancer Center at Iowa Methodist Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology and Hematology Associates at John Stoddard Cancer Center
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology and Hematology Associates at Mercy Cancer Center
state: Iowa
city: Des Moines
country: United States
facility: Mercy Cancer Center at Mercy Medical Center - Des Moines
state: Iowa
city: Des Moines
country: United States
facility: John Stoddard Cancer Center at Iowa Lutheran Hospital
state: Iowa
city: Mason City
country: United States
facility: Mercy Cancer Center at Mercy Medical Center - North Iowa
state: Iowa
city: Onawa
country: United States
facility: Burgess Health Center
state: Iowa
city: Ottumwa
country: United States
facility: Ottumwa Regional Health Center Cancer Center
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
state: Iowa
city: Sioux City
country: United States
facility: Mercy Medical Center - Sioux City
state: Iowa
city: Sioux City
country: United States
facility: St. Luke's Regional Medical Center
state: Iowa
city: West Des Moines
country: United States
facility: Medical Oncology and Hematology Associates - West Des Moines
state: Iowa
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Baton Rouge
country: United States
facility: Baton Rouge General Regional Cancer Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center - Baton Rouge
state: Louisiana
city: New Orleans
country: United States
facility: MBCCOP - LSU Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Medical Center of Louisiana - New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Tufts - New England Medical Center
state: Massachusetts
city: Adrian
country: United States
facility: Hickman Cancer Center at Bixby Medical Center
state: Michigan
city: Escanaba
country: United States
facility: Green Bay Oncology, Limited - Escanaba
state: Michigan
city: Iron Mountain
country: United States
facility: Green Bay Oncology, Limited - Iron Mountain
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Lambertville
country: United States
facility: Haematology-Oncology Associates of Ohio and Michigan, P.C.
state: Michigan
city: Monroe
country: United States
facility: Mercy Memorial Hospital System
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital - Royal Oak Campus
state: Michigan
city: Saint Joseph
country: United States
facility: Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
state: Michigan
city: Burnsville
country: United States
facility: Fairview Ridges Hospital
state: Minnesota
city: Coon Rapids
country: United States
facility: Mercy and Unity Cancer Center at Mercy Hospital
state: Minnesota
city: Duluth
country: United States
facility: CCOP - Duluth
state: Minnesota
city: Duluth
country: United States
facility: Miller-Dwan Medical Center
state: Minnesota
city: Duluth
country: United States
facility: St. Mary's - Duluth Clinic Cancer Center
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Fridley
country: United States
facility: Mercy and Unity Cancer Center at Unity Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
state: Minnesota
city: Robbinsdale
country: United States
facility: Hubert H. Humphrey Cancer Center at North Memorial Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Clinic - River Campus
state: Minnesota
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Health Services
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Waconia
country: United States
facility: Ridgeview Medical Center
state: Minnesota
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center at University of Missouri - Columbia
state: Missouri
city: Springfield
country: United States
facility: St. John's Regional Health Center
state: Missouri
city: Springfield
country: United States
facility: Hulston Cancer Center at Cox Medical Center South
state: Missouri
city: Billings
country: United States
facility: CCOP - Montana Cancer Consortium
state: Montana
city: Great Falls
country: United States
facility: Great Falls Clinic
state: Montana
city: Kearney
country: United States
facility: Good Samaritan Health Systems
state: Nebraska
city: Lincoln
country: United States
facility: Bryan LGH Medical Center West
state: Nebraska
city: Lincoln
country: United States
facility: Cancer Resource Center - Lincoln
state: Nebraska
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Omaha
country: United States
facility: Methodist Cancer Center at Methodist Hospital - Omaha
state: Nebraska
city: Omaha
country: United States
facility: Immanuel Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Bergan Mercy Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Papillion
country: United States
facility: Midlands Cancer Center at Midlands Community Hospital
state: Nebraska
city: Las Vegas
country: United States
facility: CCOP - Nevada Cancer Research Foundation
state: Nevada
city: East Orange
country: United States
facility: Veterans Affairs Medical Center - East Orange
state: New Jersey
city: Flemington
country: United States
facility: Hunterdon Regional Cancer Center at Hunterdon Medical Center
state: New Jersey
city: Marlton
country: United States
facility: Fox Chase Virtua Health Cancer Program - Marlton
state: New Jersey
city: Red Bank
country: United States
facility: Booker Cancer Center at Riverview Medical Center
state: New Jersey
city: Somers Point
country: United States
facility: Shore Memorial Hospital - Somers Point
state: New Jersey
city: Toms River
country: United States
facility: Community Regional Cancer Center at Community Medical Center
state: New Jersey
city: Cooperstown
country: United States
facility: Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
state: New York
city: Goldsboro
country: United States
facility: Wayne Memorial Hospital, Incorporated
state: North Carolina
city: Greenville
country: United States
facility: Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
state: North Carolina
city: Wilmington
country: United States
facility: Zimmer Cancer Center at New Hanover Regional Medical Center
state: North Carolina
city: Wilson
country: United States
facility: Wilson Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Regional Cancer Center at Forsyth Medical Center
state: North Carolina
city: Bismarck
country: United States
facility: Bismarck Cancer Center
state: North Dakota
city: Bismarck
country: United States
facility: Cancer Care Center at Medcenter One Hospital
state: North Dakota
city: Bismarck
country: United States
facility: Mid Dakota Clinic, P.C.
state: North Dakota
city: Bismarck
country: United States
facility: St. Alexius Medical Center
state: North Dakota
city: Minot
country: United States
facility: Trinity Cancer Care Center
state: North Dakota
city: Boardman
country: United States
facility: St. Elizabeth Boardman Cancer Center
state: Ohio
city: Canton
country: United States
facility: University Hospitals Ireland Cancer Center at Mercy Medical Center
state: Ohio
city: Canton
country: United States
facility: Aultman Hospital Cancer Center at Aultman Health Foundation
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth's Cancer Care Center at MetroHealth Medical Center
state: Ohio
city: Findlay
country: United States
facility: Blanchard Valley Medical Associates
state: Ohio
city: Fremont
country: United States
facility: Fremont Memorial Hospital
state: Ohio
city: Lima
country: United States
facility: St. Rita's Medical Center
state: Ohio
city: Lima
country: United States
facility: Lima Memorial Hospital
state: Ohio
city: Maumee
country: United States
facility: St. Luke's Hospital
state: Ohio
city: Oregon
country: United States
facility: St. Charles Mercy Hospital
state: Ohio
city: Sandusky
country: United States
facility: Firelands Regional Medical Center
state: Ohio
city: Sylvania
country: United States
facility: Promedica Cancer Center at Flower Hospital
state: Ohio
city: Tiffin
country: United States
facility: Mercy Hospital of Tiffin
state: Ohio
city: Toledo
country: United States
facility: Toledo Hospital
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Center
state: Ohio
city: Toledo
country: United States
facility: Medical College of Ohio Cancer Institute
state: Ohio
city: Toledo
country: United States
facility: CCOP - Toledo Community Hospital
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic, Incorporated - Main Clinic
state: Ohio
city: Warren
country: United States
facility: St. Joseph Health Care Center
state: Ohio
city: Wauseon
country: United States
facility: Fulton County Health Center
state: Ohio
city: Youngstown
country: United States
facility: St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown
state: Ohio
city: Tulsa
country: United States
facility: Natalie Warren Bryant Cancer Center at St. Francis Hospital
state: Oklahoma
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Delaware County Regional Cancer Center at Delaware County Memorial Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Cancer Institute at Milton S. Hershey Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Lewistown
country: United States
facility: Lewistown Hospital
state: Pennsylvania
city: Paoli
country: United States
facility: Paoli Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Cancer Center
state: Pennsylvania
city: Phoenixville
country: United States
facility: Phoenixville Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Hillman Cancer Center at University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Veterans Affairs Medical Center - Pittsburgh
state: Pennsylvania
city: Reading
country: United States
facility: St. Joseph Medical Center
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Medical Center - Sayre
state: Pennsylvania
city: Scranton
country: United States
facility: Hematology and Oncology Associates
state: Pennsylvania
city: State College
country: United States
facility: Mount Nittany Medical Center
state: Pennsylvania
city: West Chester
country: United States
facility: Chester County Hospital
state: Pennsylvania
city: West Grove
country: United States
facility: Jennersville Regional Hospital
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: CCOP - MainLine Health
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Cancer Center at Lankenau Hospital
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sioux Valley Hospital and University of South Dakota Medical Center
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera McKennan Hospital and University Health Center
state: South Dakota
city: Sioux Falls
country: United States
facility: Medical X-Ray Center, P. C.
state: South Dakota
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Knoxville
country: United States
facility: Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
state: Tennessee
city: Laredo
country: United States
facility: Doctor's Hospital of Laredo
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center Cancer Institute
state: Texas
city: Murray
country: United States
facility: Cottonwood Hospital Medical Center
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Hospital Center
state: Utah
city: Provo
country: United States
facility: Utah Valley Regional Medical Center - Provo
state: Utah
city: Saint George
country: United States
facility: Dixie Regional Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists at UCS Cancer Center
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Charlottesville
country: United States
facility: Martha Jefferson Hospital Cancer Care Center
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Cancer Care at St. Mary's Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
state: Washington
city: Charleston
country: United States
facility: West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
state: West Virginia
city: Huntington
country: United States
facility: Marshall University Medical Center
state: West Virginia
city: Fond Du Lac
country: United States
facility: Central Wisconsin Cancer Program at Agnesian HealthCare
state: Wisconsin
city: Green Bay
country: United States
facility: Green Bay Oncology, Limited at St. Vincent Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: St. Vincent Hospital Regional Cancer Center
state: Wisconsin
city: Green Bay
country: United States
facility: Green Bay Oncology, Limited at St. Mary's Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: St. Mary's Hospital Medical Center
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
state: Wisconsin
city: Manitowoc
country: United States
facility: Cancer Care Center at Holy Family Memorial Medical Center
state: Wisconsin
city: Marinette
country: United States
facility: Bay Area Cancer Care Center at Bay Area Medical Center
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic - Marshfield Center
state: Wisconsin
city: Oconto Falls
country: United States
facility: Green Bay Oncology, Limited - Oconto Falls
state: Wisconsin
city: Sturgeon Bay
country: United States
facility: Green Bay Oncology, Limited - Sturgeon Bay
state: Wisconsin
city: Wausau
country: United States
facility: University of Wisconsin Cancer Center at Aspirus Wausau Hospital
state: Wisconsin
city: Pretoria, 0001
country: South Africa
facility: Pretoria Academic Hospital
Study officials:
affiliation: Indiana University Melvin and Bren Simon Cancer Center
name: Patrick J. Loehrer, MD
role: STUDY_CHAIR
References:
citation: Loehrer PJ, Powell ME, Cardenes HR, et al.: A randomized phase III study of gemcitabine in combination with radiation therapy versus gemcitabine alone in patients with localized, unresectable pancreatic cancer: E4201. [Abstract] J Clin Oncol 26 (Suppl 15): A-4506, 2008.