Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00049348
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of margin-free resections produced by each program
- Secondary Outcome Measures
Name Time Method Efficacy as measured by CT scan response Post-treatment fibrosis in the resected specimens Toxicity Duration of objective response Disease-free survival Overall survival Effect of therapy and recurrence on CA19-9 values
Trial Locations
- Locations (137)
Mason District Hospital
🇺🇸Havana, Illinois, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Hematology and Oncology Associates
🇺🇸Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Swedish Covenant Hospital
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
Mercy Hospital and Medical Center
🇺🇸Chicago, Illinois, United States
Eureka Hospital
🇺🇸Eureka, Illinois, United States
Hematology Oncology Associates - Skokie
🇺🇸Skokie, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Northwest Medical Specialist P.C.
🇺🇸Niles, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
McFarland Clinic, P.C.
🇺🇸Ames, Iowa, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Saint Joseph Regional Medical Center - Plymouth Campus
🇺🇸Plymouth, Indiana, United States
Hematology/Oncology of the North Shore
🇺🇸Skokie, Illinois, United States
Midwest Cancer Research Group, Incorporated
🇺🇸Skokie, Illinois, United States
Baton Rouge General Regional Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Noble Hospital
🇺🇸Westfield, Massachusetts, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
🇺🇸Fridley, Minnesota, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Franklin Medical Center
🇺🇸Greenfield, Massachusetts, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
St. Elizabeth Boardman Cancer Center
🇺🇸Boardman, Ohio, United States
Medical X-Ray Center
🇺🇸Sioux Falls, South Dakota, United States
Erlanger Cancer Center
🇺🇸Chattanooga, Tennessee, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
MeritCare Medical Group
🇺🇸Fargo, North Dakota, United States
St. Luke's Hospital Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
Holyoke Medical Center, Incorporated
🇺🇸Holyoke, Massachusetts, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Mary Bird Perkins Cancer Center - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Woodwinds Hospital
🇺🇸Woodbury, Minnesota, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
🇺🇸Charleston, West Virginia, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown
🇺🇸Youngstown, Ohio, United States
Mount Nittany Medical Center
🇺🇸State College, Pennsylvania, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
St. Joseph Health Care Center
🇺🇸Warren, Ohio, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Cancer Center of Kansas, P.A. - Wichita
🇺🇸Wichita, Kansas, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas - Wellington
🇺🇸Wellington, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, P.A.
🇺🇸Wichita, Kansas, United States
Associates in Womens Health
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Salina
🇺🇸Salina, Kansas, United States
Pratt Cancer Center of Kansas
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas - Ottawa
🇺🇸Ottawa, Kansas, United States
Cancer Center of Kansas - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas - Kingman
🇺🇸Kingman, Kansas, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Cancer Care Center at Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
Saint Francis Cancer Center
🇺🇸Shakopee, Minnesota, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Lynn Regional Cancer Center of Boca Raton Community Hospital
🇺🇸Boca Raton, Florida, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Medical Center of Central Georgia
🇺🇸Macon, Georgia, United States
St. Anthony's Memorial Hospital
🇺🇸Effingham, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Midwest Center for Hematology/Oncology
🇺🇸Joliet, Illinois, United States
Joliet Oncology Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Deerpath Medical Associates
🇺🇸Lake Forest, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
🇺🇸Libertyville, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Oncology Hematology Associates of Central Illinois - Ottawa
🇺🇸Ottawa, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Swedish American Hospital
🇺🇸Rockford, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Cancer Center of Kansas, P.A. - El Dorado
🇺🇸El Dorado, Kansas, United States
Siouxland Hematology-Oncology Associates
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas - Newton
🇺🇸Newton, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
🇺🇸Springfield, Massachusetts, United States
MeritCare Clinic - Bemidji
🇺🇸Bemidji, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸Litchfield, Minnesota, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Park Nicollet Clinic
🇺🇸Saint Louis Park, Minnesota, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Mid Dakota Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
St. Rita's Medical Center
🇺🇸Lima, Ohio, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Lewistown Hospital
🇺🇸Lewistown, Pennsylvania, United States
Avera McKennan Hospital and University Health Center
🇺🇸Sioux Falls, South Dakota, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
St. Mary's Hospital Medical Center
🇺🇸Green Bay, Wisconsin, United States
Evanston Northwestern Health Care - Evanston Hospital
🇺🇸Evanston, Illinois, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Green Bay Oncology, Limited at St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Cancer Center at Medical Center of Louisiana - New Orleans
🇺🇸New Orleans, Louisiana, United States
Cancer Center of Kansas - Winfield
🇺🇸Winfield, Kansas, United States