Pancreatic Cancer Clinical Trial
Official title:
Vapreotide in Pancreas Surgery: A Double-Blind, Placebo-Controlled, Randomized Study of Vapreotide to Prevent Post-Surgical Complications in Patients Undergoing Elective Pancreatic Resection Grant Application Title: Vapreotide to Prevent Complications of Pancreatic Resection
RATIONALE: Drugs such as vapreotide may prevent complications following pancreatic
resection. It is not yet known if vapreotide is more effective than no further therapy in
preventing side effects of pancreatic resection.
PURPOSE: This randomized phase III trial is studying vapreotide to see how well it works
compared to a placebo in preventing complications in patients undergoing surgery for
pancreatic cancer.
OBJECTIVES: I. Compare the efficacy of vapreotide versus placebo in reducing postoperative
pancreatic complications in patients undergoing elective pancreatic resection. II. Compare
the postoperative complications occurring within 45 days after surgery unrelated to the
pancreas, days of hospitalization and survival at 45 days after surgery, number of
rehospitalizations, and number of postoperative blood units or packed red blood cells
administered in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are randomized to one of two treatment arms. Arm I: Patients undergo surgical resection on
day 1 and receive vapreotide subcutaneously twice daily on days 1-7. Arm II: Patients
undergo surgical resection and receive a placebo as in arm I. Patients are followed at days
28 and 45.
PROJECTED ACCRUAL: A total of 580 patients (290 per arm) will be accrued for this study.
;
Primary Purpose: Supportive Care
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