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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00026130 |
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.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: fluorouracil Drug: gemcitabine hydrochloride Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma |
Study Start Date: | September 2001 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed pancreatic adenocarcinoma
Non-metastatic disease that is unresectable due to any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Harvey J. Mamon, MD, PhD | Dana-Farber/Brigham and Women's Cancer Center |
Study ID Numbers: | CDR0000068988, CALGB-80003 |
Study First Received: | November 9, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00026130 |
Health Authority: | United States: Federal Government |
stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas |
Digestive System Diseases Digestive System Neoplasms Fluorouracil Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Adenocarcinoma Pancrelipase Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |