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A Randomized Phase II Study Of Gemcitabine Plus Radiotherapy Vs. Gemcitabine, 5-Fluorouracil And Cisplatin Followed By Radiotherapy And 5-Fluoraracil For Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

A Randomized Phase II Study Of Gemcitabine Plus Radiotherapy Vs. Gemcitabine, 5-Fluorouracil And Cisplatin Followed By Radiotherapy And 5-Fluoraracil For Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma


OBJECTIVES:

- Compare the percentage of margin-free resections in patients with locally advanced,
potentially resectable adenocarcinoma of the pancreas treated with gemcitabine and
radiotherapy vs gemcitabine, fluorouracil, and cisplatin followed by radiotherapy and
fluorouracil.

- Compare the efficacy of these regimens, as measured by CT scan response, in these
patients.

- Compare the posttreatment fibrosis in resected specimens of patients treated with these
regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the duration of objective response in patients treated with these regimens.

- Compare the disease-free and overall survival of patients treated with these regimens.

- Compare the effect of these regimens and disease recurrence on CA 19-9 values in these
patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
superior mesenteric vein (SMV)/portal vein (PV) occlusion (yes vs no), SMV/PV/superior
mesenteric artery/hepatic artery abutment or narrowing (yes vs no), prior exploration (yes
vs no), and whether deemed to require preoperative therapy due to other factors (yes vs no).
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients
receive gemcitabine IV over 50 minutes once weekly for 6 weeks during radiotherapy.
Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy.

Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV
over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 5 courses in
the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 5, 29, and 33;
cisplatin IV over 60 minutes on days 1-5 and 29-33; and fluorouracil IV continuously on
days 1-4 and 29-32. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily
on days 6-15 and 34-43 and epoetin alfa SC weekly on weeks 1-9. After completion of
chemotherapy, patients undergo radiotherapy once daily 5 days a week for 6 weeks.
Patients receive fluorouracil IV continuously daily during radiotherapy. Patients
undergo surgical resection 4-6 weeks after completion of chemoradiotherapy.

Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV
over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 3 courses in
the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 80-160 patients (40-80 per treatment arm) will be accrued for
this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the pancreas

- No adenosquamous cancers or adenocarcinoma associated with cystic mucinous
neoplasms

- Locally advanced disease that is potentially resectable, previously explored and
considered unresectable, or deemed to require preoperative treatment for other
reasons

- Primary cancer in the head, body, or tail of pancreas

- Measurable disease

- No 360 degree encirclement of the superior mesenteric artery, hepatic artery, or
celiac axis

- No metastases by CT scan and laparoscopy (if prior surgery, only CT scan required)

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count greater than 2,000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic

- Bilirubin less than 2 mg/dL (unless secondary to bile duct blockage by tumor)

- Biliary obstruction by tumor requires biliary stent at least 9 French or biliary
bypass before therapy

Renal

- Creatinine less than 1.7 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Other

- No other malignancy within the past 3 years except nonmelanoma skin cancer

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for this disease

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy to pancreas

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Percentage of margin-free resections produced by each program

Safety Issue:

No

Principal Investigator

John Parker Hoffman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000258056

NCT ID:

NCT00049348

Start Date:

May 2003

Completion Date:

Related Keywords:

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

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - WichitaWichita, Kansas  67214-3882
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Rush-Copley Cancer Care CenterAurora, Illinois  60507
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
Baystate Regional Cancer Program at D'Amour Center for Cancer CareSpringfield, Massachusetts  01199
Fairview Ridges HospitalBurnsville, Minnesota  55337
Fairview Southdale HospitalEdina, Minnesota  55435
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
CCOP - MeritCare HospitalFargo, North Dakota  58122
St. Rita's Medical CenterLima, Ohio  45801
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
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Wesley Medical CenterWichita, Kansas  67214
Medical Center of Central GeorgiaMacon, Georgia  31201
Evanston Northwestern Health Care - Evanston HospitalEvanston, Illinois  60201
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - KingmanKingman, Kansas  67068
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Pratt Cancer Center of KansasPratt, Kansas  67124
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A.Wichita, Kansas  67208
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Medical X-Ray CenterSioux Falls, South Dakota  57105
Medcenter One Health SystemBismarck, North Dakota  58501
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Elkhart General HospitalElkhart, Indiana  46515
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
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
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
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
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Franklin Medical CenterGreenfield, Massachusetts  01301
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
MeritCare Medical GroupFargo, North Dakota  58122
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Eureka HospitalEureka, Illinois  61530
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
Oncology Hematology Associates of Central Illinois - OttawaOttawa, Illinois  61350
Cancer Center of Kansas - OttawaOttawa, Kansas  66067
Baton Rouge General Regional Cancer CenterBaton Rouge, Louisiana  70821
Cancer Center at Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70140-1015
Mercy HospitalCoon Rapids, Minnesota  55433
Mercy and Unity Cancer Center at Mercy and Unity HospitalsFridley, Minnesota  55432-2799
Park Nicollet ClinicSt. Louis Park, Minnesota  55416
St. Anthony's Memorial HospitalEffingham, Illinois  62401
Deerpath Medical AssociatesLake Forest, Illinois  60045
McFarland Clinic, P.C.Ames, Iowa  50010
St. John's HospitalMaplewood, Minnesota  55109
Mid Dakota Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
Swedish American HospitalRockford, Illinois  61104
Saint Joseph Regional Medical Center - Plymouth CampusPlymouth, Indiana  46544
Cancer Care Center at Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Cancer CenterShakopee, Minnesota  55379
St. Joseph's HospitalSt Paul, Minnesota  55102
Woodwinds HospitalWoodbury, Minnesota  55125
St. Mary's Hospital Medical CenterGreen Bay, Wisconsin  54303
Lynn Regional Cancer Center of Boca Raton Community HospitalBoca Raton, Florida  33486
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
Erlanger Cancer CenterChattanooga, Tennessee  37403
Noble HospitalWestfield, Massachusetts  01085
Northwest Medical Specialist P.C.Niles, Illinois  60714
Hematology/Oncology of the North ShoreSkokie, Illinois  60076
Holyoke Medical Center, IncorporatedHolyoke, Massachusetts  01040