Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00049348
First received: November 12, 2002
Last updated: November 12, 2010
Last verified: June 2005
  Purpose

RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens combining chemotherapy with radiation therapy in treating patients who are undergoing surgery for locally advanced pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Biological: epoetin alfa
Biological: filgrastim
Drug: cisplatin
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Percentage of margin-free resections produced by each program [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy as measured by CT scan response [ Designated as safety issue: No ]
  • Post-treatment fibrosis in the resected specimens [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Duration of objective response [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Effect of therapy and recurrence on CA19-9 values [ Designated as safety issue: No ]

Study Start Date: May 2003
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049348

  Hide Study Locations
Locations
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8032
United States, Florida
Lynn Regional Cancer Center of Boca Raton Community Hospital
Boca Raton, Florida, United States, 33486
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224-9980
United States, Georgia
Emory University Hospital - Atlanta
Altanta, Georgia, United States, 30322
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
Medical Center of Central Georgia
Macon, Georgia, United States, 31208
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
St. Anthony's Memorial Hospital
Effingham, Illinois, United States, 62401
Eureka Hospital
Eureka, Illinois, United States, 61530
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States, 61401
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Deerpath Medical Associates
Lake Forest, Illinois, United States, 60045
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States, 60048
McDonough District Hospital
Macomb, Illinois, United States, 61455
Northwest Medical Specialist P.C.
Niles, Illinois, United States, 60714
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois, United States, 61350
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61615
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Swedish American Hospital
Rockford, Illinois, United States, 61104
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States, 60076
Hematology/Oncology of the North Shore
Skokie, Illinois, United States, 60076
Midwest Cancer Research Group, Incorporated
Skokie, Illinois, United States, 60077
Valley Cancer Center
Spring Valley, Illinois, United States, 61362
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center - Plymouth Campus
Plymouth, Indiana, United States, 46544
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic, P.C.
Ames, Iowa, United States, 50010
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States, 51101
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101-1733
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Kingman
Kingman, Kansas, United States, 67068
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Ottawa
Ottawa, Kansas, United States, 66067
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States, 67357
Pratt Cancer Center of Kansas
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Wesley Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A.
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Associates in Womens Health
Wichita, Kansas, United States, 67203
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, United States, 70806
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Cancer Center at Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States, 70112
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Franklin Medical Center
Greenfield, Massachusetts, United States, 01301
Holyoke Medical Center, Incorporated
Holyoke, Massachusetts, United States, 01040
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01199
Noble Hospital
Westfield, Massachusetts, United States, 01085
United States, Minnesota
MeritCare Clinic - Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Litchfield, Minnesota, United States, 55355
St. John's Hospital
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Cancer Care Center at Regions Hospital
Saint Paul, Minnesota, United States, 55101
Saint Francis Cancer Center
Shakopee, Minnesota, United States, 55379
St. Joseph's Hospital
St Paul, Minnesota, United States, 55102
Park Nicollet Clinic
St. Louis Park, Minnesota, United States, 55416
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Woodwinds Hospital
Woodbury, Minnesota, United States, 55125
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
United States, North Dakota
St. Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Medcenter One Health System
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, United States, 58501
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Medical Group
Fargo, North Dakota, United States, 58122
United States, Ohio
St. Elizabeth Boardman Cancer Center
Boardman, Ohio, United States, 44512
St. Rita's Medical Center
Lima, Ohio, United States, 45801
St. Joseph Health Care Center
Warren, Ohio, United States, 44484
St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown
Youngstown, Ohio, United States, 44510
United States, Pennsylvania
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
United States, South Dakota
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57104
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Erlanger Cancer Center
Chattanooga, Tennessee, United States, 37403
United States, West Virginia
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, United States, 25304
United States, Wisconsin
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
St. Mary's Hospital Medical Center
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: John Parker Hoffman, MD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Landry JC, Catalano P, Hoffman J, et al.: ECOG 1200: a randomized phase II trial of gemcitabine plus radiotherapy vs gemcitabine, 5-fluorouracil and cisplatin followed by radiotherapy and 5-fluorouracil in patients with locally advanced, potentially resectable pancreatic adenocarcinoma. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2111, S272, 2006.

Responsible Party: Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00049348     History of Changes
Other Study ID Numbers: CDR0000258056, E1200
Study First Received: November 12, 2002
Last Updated: November 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:
adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Cisplatin
Epoetin alfa
Fluorouracil
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Hematinics
Hematologic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014