Pancreatic Cancer Clinical Trial
Official title:
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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