Spots Global Cancer Trial Database for Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer
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Trial Identification
Brief Title: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer
Official Title: A Phase II Study of Gemcitabine, Cisplatin and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer
Study ID: NCT00026403
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer.
Detailed Description: OBJECTIVES: * Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year survival, in patients with locally advanced pancreatic cancer. * Determine the toxicity of this regimen in these patients. * Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
Siouxland Hematology-Oncology, Sioux City, Iowa, United States
CCOP - Wichita, Wichita, Kansas, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
CCOP - Duluth, Duluth, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CentraCare Health Plaza, Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Medcenter One Health System, Bismarck, North Dakota, United States
CCOP - Merit Care Hospital, Fargo, North Dakota, United States
Altru Cancer Center, Grand Forks, North Dakota, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Contact Details
Name: Michael G. Haddock, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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