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A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival Time

Outcome Description:

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.

Outcome Time Frame:

assessed every 3 months for 2 years, then every 6 months for year 3

Safety Issue:

No

Principal Investigator

Patrick J. Loehrer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000278947

NCT ID:

NCT00057876

Start Date:

April 2003

Completion Date:

May 2009

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • Pancreatic Neoplasms

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