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A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer
RATIONALE: Surgery to remove the pancreas, some of the small intestine, and lymph nodes may be more effective treatment for cancer of the pancreas than surgery to remove the pancreas and some of the small intestine alone. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery, radiation therapy, and chemotherapy may be an effective treatment for cancer of the pancreas. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the pancreas and a portion of the small intestine with or without removing lymph nodes, followed by radiation therapy and chemotherapy, in treating patients with cancer of the pancreas.
OBJECTIVES: * Assess the overall survival of patients with resectable ductal pancreatic adenocarcinoma undergoing extended versus standard pancreatoduodenectomy. OUTLINE: Patients are randomized to undergo standard pancreatoduodenectomy (PD) or PD with extended lymph node resection after an exploratory laparotomy. Patients receive adjuvant chemoradiation therapy 4-6 weeks after surgery, if no metastases are evident. Radiation therapy is given every week for 5 weeks. Fluorouracil/leucovorin calcium is administered by rapid IV push daily within 2 hours of radiation on days 1-4 of week 1 and days 29-31 of week 5. Patients are followed every 4 months for the first year, then every 6 months for the next 2 years. PROJECTED ACCRUAL: 50 patients will be accrued per group for a total of 100 patients.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Start Date
May 1, 1997
Primary Completion Date
August 1, 2005
Completion Date
July 1, 2007
Last Updated
December 22, 2016
100
ESTIMATED participants
fluorouracil
DRUG
leucovorin calcium
DRUG
conventional surgery
PROCEDURE
radiation therapy
RADIATION
Lead Sponsor
Mayo Clinic
Collaborators
NCT04550494
NCT05053971
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