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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 - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Bergan Mercy Medical CenterOmaha, Nebraska  68124
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
St. Rita's Medical CenterLima, Ohio  45801
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Halifax Medical CenterDaytona Beach, Florida  32114
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Great Falls ClinicGreat Falls, Montana  59405
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Tufts - New England Medical CenterBoston, Massachusetts  02111
Doctors Medical CenterModesto, California  95350
Evanston Northwestern Health Care - Evanston HospitalEvanston, Illinois  60201
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Central Baptist HospitalLexington, Kentucky  40503
Trinity Cancer Care CenterMinot, North Dakota  58701
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
New Britain General HospitalNew Britain, Connecticut  06050
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Toledo HospitalToledo, Ohio  43606
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Hunterdon Regional Cancer Center at Hunterdon Medical CenterFlemington, New Jersey  08822
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
Chester County HospitalWest Chester, Pennsylvania  19380
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Banner Good Samaritan Medical CenterPhoenix, Arizona  85006
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Fox Chase Virtua Health Cancer Program - MarltonMarlton, New Jersey  08053
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Yale Comprehensive Cancer Center at Yale University School of MedicineNew Haven, Connecticut  06520-8064
Leo W. Jenkins Cancer Center at Pitt County Memorial HospitalGreenville, North Carolina  27858-4354
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Elkhart General HospitalElkhart, Indiana  46515
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
Jennersville Regional HospitalWest Grove, Pennsylvania  19390-9499
Memorial Medical Center Cancer ServicesModesto, California  95355
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Swedish Covenant HospitalChicago, Illinois  60625
Mercy Hospital and Medical CenterChicago, Illinois  60616
Hematology and Oncology AssociatesChicago, Illinois  60611
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
Kewanee HospitalKewanee, Illinois  61443
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
McDonough District HospitalMacomb, Illinois  61455
Northwest Medical Specialist, PCNiles, Illinois  60714
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
Midwest Cancer Research Group, IncorporatedSkokie, Illinois  60077
Hematology/Oncology of the North Shore at Gross Point Medical CenterSkokie, Illinois  60076
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Burgess Health CenterOnawa, Iowa  51040
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Green Bay Oncology, Limited - Iron MountainIron Mountain, Michigan  49801
Haematology-Oncology Associates of Ohio and Michigan, P.C.Lambertville, Michigan  48144
Mercy Memorial Hospital SystemMonroe, Michigan  48162
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Bryan LGH Medical Center WestLincoln, Nebraska  68502
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Booker Cancer Center at Riverview Medical CenterRed Bank, New Jersey  07701
Wilson Medical CenterWilson, North Carolina  27893-3428
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Fremont Memorial HospitalFremont, Ohio  43420
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
St. Charles Mercy HospitalOregon, Ohio  43616
Firelands Regional Medical CenterSandusky, Ohio  44870
Promedica Cancer Center at Flower HospitalSylvania, Ohio  43560
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Delaware County Regional Cancer Center at Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Hematology and Oncology AssociatesScranton, Pennsylvania  18510
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Baptist Regional Cancer Center at Baptist Hospital of East TennesseeKnoxville, Tennessee  37901
Doctor's Hospital of LaredoLaredo, Texas  78041
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
Baton Rouge General Regional Cancer CenterBaton Rouge, Louisiana  70821
William W. Backus HospitalNorwich, Connecticut  06360
St. Anthony's Memorial HospitalEffingham, Illinois  62401
Deerpath Medical AssociatesLake Forest, Illinois  60045
McFarland Clinic, P.C.Ames, Iowa  50010
Miller-Dwan Medical CenterDuluth, Minnesota  55805
Mid Dakota Clinic, P.C.Bismarck, North Dakota  58501
Lancaster General HospitalLancaster, Pennsylvania  17604-3555
California Cancer Center - Woodward Park OfficeFresno, California  93720
Northeast Georgia Medical CenterGainesville, Georgia  30501
Pearlman Comprehensive Cancer Center at South Georgia Medical CenterValdosta, Georgia  31603
Swedish American HospitalRockford, Illinois  61104
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Louis Busch Hager Cancer Center at Mary Imogene Bassett HospitalCooperstown, New York  13326
University Hospitals Ireland Cancer Center at Mercy Medical CenterCanton, Ohio  44708
Medical College of Ohio Cancer InstituteToledo, Ohio  43614
St. Joseph Medical CenterReading, Pennsylvania  19604
Guthrie Medical Center - SayreSayre, Pennsylvania  18840
Bon Secours Cancer Care at St. Mary's HospitalRichmond, Virginia  23226
St. Mary's Hospital Medical CenterGreen Bay, Wisconsin  54303
William N. Wishard Memorial HospitalIndianapolis, Indiana  46202
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
Saint Joseph's Mercy Cancer CenterHot Springs, Arkansas  71913
Martha Jefferson Hospital Cancer Care CenterCharlottesville, Virginia  22901
Good Samaritan Health SystemsKearney, Nebraska  68847
Cancer Care and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405-6013
La Grange Memorial HospitalLa Grange, Illinois  60525
Shore Memorial Hospital - Somers PointSomers Point, New Jersey  08244
Marshall University Medical CenterHuntington, West Virginia  25701
Community Regional Cancer Center at Community Medical CenterToms River, New Jersey  08755
Provena St. Mary's Wasser Regional Cancer Center - KankakeeKankakee, Illinois  60901
St. Elizabeth Boardman Cancer CenterBoardman, Ohio  44512
St. Joseph Health Care CenterWarren, Ohio  44484
St. Elizabeth Cancer Center at St. Elizabeth Health Center - YoungstownYoungstown, Ohio  44510
University of Wisconsin Cancer Center at Aspirus Wausau HospitalWausau, Wisconsin  54401
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer CenterSioux City, Iowa  51101
Ottumwa Regional Health Center Cancer CenterOttumwa, Iowa  52501
Cancer Care Center at Holy Family Memorial Medical CenterManitowoc, Wisconsin  54221
Central Wisconsin Cancer Program at Agnesian HealthCareFond du Lac, Wisconsin  54935
Medical X-Ray Center, P. C.Sioux Falls, South Dakota  57105
Phoenixville HospitalPhoenixville, Pennsylvania  19460
East Texas Medical Center Cancer InstituteTyler, Texas  75701