Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00026130
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced pancreatic cancer.
- Detailed Description
OBJECTIVES:
* Determine the overall survival of patients with locally advanced non-metastatic pancreatic adenocarcinoma treated with gemcitabine, fluorouracil, and radiotherapy.
* Determine the time to progression in patients treated with this regimen.
* Determine the overall clinical response in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes once weekly and fluorouracil IV continuously on days 1-5 weekly for 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 6 weeks.
Three weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 24 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine + 5FU + XRT radiation therapy Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer Gemcitabine + 5FU + XRT gemcitabine hydrochloride Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer Gemcitabine + 5FU + XRT fluorouracil Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer
- Primary Outcome Measures
Name Time Method Overall Survival 9 months up to 3 years post treatment
- Secondary Outcome Measures
Name Time Method Clinical Response q 2 mon for Yr 1 post Tx, then q 3 mon for 2 yrs CA19-9 Levels q cycle, then q 2 mon for 1 yr, then q 3 mon for 2 yrs Biomarker response
Toxicity q cycle Time to progression After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs
Trial Locations
- Locations (77)
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Lenoir Memorial Hospital Cancer Center
🇺🇸Kinston, North Carolina, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
Hematology Oncology Associates of the Quad Cities
🇺🇸Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
University Hospital at State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
NorthEast Oncology Associates - Concord
🇺🇸Concord, North Carolina, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Arthur G. James Cancer Hospital at Ohio State University
🇺🇸Columbus, Ohio, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Memorial Regional Cancer Center at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
New Hampshire Oncology-Hematology, PA - Hooksett
🇺🇸Hooksett, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸East Syracuse, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
🇺🇸Roanoke, Virginia, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States