A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery
Anemia and fatigue are common problems in gastric and rectal cancer subjects at the
completion of chemoradiation therapy and surgery. Results of several studies in cancer
subjects suggest that treatment with epoetin alfa may be effective in maintaining hemoglobin
levels, thereby reducing fatigue, decreasing transfusion requirement, and potentially
improving quality of life.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Number of Patients with Reduction in Red Blood Cell Transfusions
Saroj Vadhan-Raj, M.D.
UT MDAnderson Cancer Center
United States: Food and Drug Administration
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