A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival Time
Overall survival was defined as the time from randomization (registration) to death from any cause. Patients alive at last follow-up were censored. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients received treatment beyond 3 years were also followed for survival.
assessed every 3 months for 2 years, then every 6 months for year 3
No
Patrick J. Loehrer, MD
Study Chair
Indiana University Melvin and Bren Simon Cancer Center
United States: Federal Government
CDR0000278947
NCT00057876
April 2003
May 2009
Name | Location |
---|---|
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington, Connecticut 06360-2875 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Halifax Medical Center | Daytona Beach, Florida 32114 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
Dixie Regional Medical Center | Saint George, Utah 84770 |
LDS Hospital | Salt Lake City, Utah 84143 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - Pittsburgh | Pittsburgh, Pennsylvania 15240 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Midlands Cancer Center at Midlands Community Hospital | Papillion, Nebraska 68128-4157 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
Great Falls Clinic | Great Falls, Montana 59405 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
Tufts - New England Medical Center | Boston, Massachusetts 02111 |
Doctors Medical Center | Modesto, California 95350 |
Evanston Northwestern Health Care - Evanston Hospital | Evanston, Illinois 60201 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Trinity Cancer Care Center | Minot, North Dakota 58701 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
New Britain General Hospital | New Britain, Connecticut 06050 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Toledo Hospital | Toledo, Ohio 43606 |
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston, West Virginia 25302 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
Chester County Hospital | West Chester, Pennsylvania 19380 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Banner Good Samaritan Medical Center | Phoenix, Arizona 85006 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Fox Chase Virtua Health Cancer Program - Marlton | Marlton, New Jersey 08053 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Avera McKennan Hospital and University Health Center | Sioux Falls, South Dakota 57105 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Yale Comprehensive Cancer Center at Yale University School of Medicine | New Haven, Connecticut 06520-8064 |
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | Greenville, North Carolina 27858-4354 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Hematology Oncology Associates - Skokie | Skokie, Illinois 60076 |
Jennersville Regional Hospital | West Grove, Pennsylvania 19390-9499 |
Memorial Medical Center Cancer Services | Modesto, California 95355 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Swedish Covenant Hospital | Chicago, Illinois 60625 |
Mercy Hospital and Medical Center | Chicago, Illinois 60616 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
Midwest Center for Hematology/Oncology | Joliet, Illinois 60432 |
Kewanee Hospital | Kewanee, Illinois 61443 |
North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois 60048 |
McDonough District Hospital | Macomb, Illinois 61455 |
Northwest Medical Specialist, PC | Niles, Illinois 60714 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Midwest Cancer Research Group, Incorporated | Skokie, Illinois 60077 |
Hematology/Oncology of the North Shore at Gross Point Medical Center | Skokie, Illinois 60076 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
Fort Wayne Medical Oncology and Hematology | Fort Wayne, Indiana 46815 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Burgess Health Center | Onawa, Iowa 51040 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Medical Center of Louisiana - New Orleans | New Orleans, Louisiana 70112 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
Haematology-Oncology Associates of Ohio and Michigan, P.C. | Lambertville, Michigan 48144 |
Mercy Memorial Hospital System | Monroe, Michigan 48162 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Bryan LGH Medical Center West | Lincoln, Nebraska 68502 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Booker Cancer Center at Riverview Medical Center | Red Bank, New Jersey 07701 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
Cancer Care Center at Medcenter One Hospital | Bismarck, North Dakota 58501 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center | Bismarck, North Dakota 58502 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Fremont Memorial Hospital | Fremont, Ohio 43420 |
Lima Memorial Hospital | Lima, Ohio 45804 |
St. Luke's Hospital | Maumee, Ohio 43537 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
Firelands Regional Medical Center | Sandusky, Ohio 44870 |
Promedica Cancer Center at Flower Hospital | Sylvania, Ohio 43560 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Hematology and Oncology Associates | Scranton, Pennsylvania 18510 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee | Knoxville, Tennessee 37901 |
Doctor's Hospital of Laredo | Laredo, Texas 78041 |
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Joliet Oncology Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Baton Rouge General Regional Cancer Center | Baton Rouge, Louisiana 70821 |
William W. Backus Hospital | Norwich, Connecticut 06360 |
St. Anthony's Memorial Hospital | Effingham, Illinois 62401 |
Deerpath Medical Associates | Lake Forest, Illinois 60045 |
McFarland Clinic, P.C. | Ames, Iowa 50010 |
Miller-Dwan Medical Center | Duluth, Minnesota 55805 |
Mid Dakota Clinic, P.C. | Bismarck, North Dakota 58501 |
Lancaster General Hospital | Lancaster, Pennsylvania 17604-3555 |
California Cancer Center - Woodward Park Office | Fresno, California 93720 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta, Georgia 31603 |
Swedish American Hospital | Rockford, Illinois 61104 |
Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
University Hospitals Ireland Cancer Center at Mercy Medical Center | Canton, Ohio 44708 |
Medical College of Ohio Cancer Institute | Toledo, Ohio 43614 |
St. Joseph Medical Center | Reading, Pennsylvania 19604 |
Guthrie Medical Center - Sayre | Sayre, Pennsylvania 18840 |
Bon Secours Cancer Care at St. Mary's Hospital | Richmond, Virginia 23226 |
St. Mary's Hospital Medical Center | Green Bay, Wisconsin 54303 |
William N. Wishard Memorial Hospital | Indianapolis, Indiana 46202 |
Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
Saint Joseph's Mercy Cancer Center | Hot Springs, Arkansas 71913 |
Martha Jefferson Hospital Cancer Care Center | Charlottesville, Virginia 22901 |
Good Samaritan Health Systems | Kearney, Nebraska 68847 |
Cancer Care and Research Pavilion at St. Joseph's/Candler | Savannah, Georgia 31405-6013 |
La Grange Memorial Hospital | La Grange, Illinois 60525 |
Shore Memorial Hospital - Somers Point | Somers Point, New Jersey 08244 |
Marshall University Medical Center | Huntington, West Virginia 25701 |
Community Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
Provena St. Mary's Wasser Regional Cancer Center - Kankakee | Kankakee, Illinois 60901 |
St. Elizabeth Boardman Cancer Center | Boardman, Ohio 44512 |
St. Joseph Health Care Center | Warren, Ohio 44484 |
St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown | Youngstown, Ohio 44510 |
University of Wisconsin Cancer Center at Aspirus Wausau Hospital | Wausau, Wisconsin 54401 |
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center | Sioux City, Iowa 51101 |
Ottumwa Regional Health Center Cancer Center | Ottumwa, Iowa 52501 |
Cancer Care Center at Holy Family Memorial Medical Center | Manitowoc, Wisconsin 54221 |
Central Wisconsin Cancer Program at Agnesian HealthCare | Fond du Lac, Wisconsin 54935 |
Medical X-Ray Center, P. C. | Sioux Falls, South Dakota 57105 |
Phoenixville Hospital | Phoenixville, Pennsylvania 19460 |
East Texas Medical Center Cancer Institute | Tyler, Texas 75701 |