A Phase II Study of Gemcitabine, Cisplatin and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer
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.
Interventional
Primary Purpose: Treatment
Michael G. Haddock, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000069026
NCT00026403
September 2001
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
Medcenter One Health System | Bismarck, North Dakota 58501 |
CentraCare Health Plaza | Saint Cloud, Minnesota 56303 |
Altru Cancer Center | Grand Forks, North Dakota 58206 |