title: Colorectal Chemoprevention Pilot Study (SWOG-9041), randomized and placebo controlled: the importance of multiple luminal lesions.
abstract: BACKGROUND
  Colorectal cancer is common worldwide and chemoprevention has the potential of reducing the number of individuals who may suffer and perish from this disease.
  
  
  METHODS
  A randomized placebo controlled pilot study in colorectal cancer patients was performed using calcium carbonate as the test agent in a multi-institutional oncology study group.
  
  
  RESULTS
  Two hundred twenty volunteers were randomized in the study. The primary goals of compliance, accrual, and toxicity monitoring are presented. Presence of multiple adenomas at study entry and subsequent development of metachronous adenomas were recorded and found to be associated with synchronous adenomas. The secondary endpoint of recurrent adenomas indicated lower rates of new adenoma in the volunteers randomized to the calcium group.
  
  
  CONCLUSIONS
  This pilot study indicates the feasibility of enrolling survivors of colorectal cancer as study volunteers in a colorectal neoplasm chemoprevention clinical trial and oral calcium continues to be a potentially effective drug in reducing colorectal adenomas.
authors.affiliation: City of Hope Medical Center, Duarte, CA, USA. davidzjchu@yahoo.com
authors.forename: David Z J
authors.initials: DZ
authors.lastname: Chu
authors.forename: Michael A
authors.initials: MA
authors.lastname: Hussey
authors.forename: David S
authors.initials: DS
authors.lastname: Alberts
authors.forename: Frank L
authors.initials: FL
authors.lastname: Meyskens
authors.forename: Cecilia M
authors.initials: CM
authors.lastname: Fenoglio-Preiser
authors.forename: Saul E
authors.initials: SE
authors.lastname: Rivkin
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Mills
authors.forename: Jeffrey K
authors.initials: JK
authors.lastname: Giguere
authors.forename: Charles D
authors.initials: CD
authors.lastname: Blanke
authors.forename: Gary E
authors.initials: GE
authors.lastname: Goodman
mesh_terms: D000236:Adenoma / Q000517:prevention & control*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000863:Antacids / Q000627:therapeutic use*; D002119:Calcium Carbonate / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D010865:Pilot Projects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000863:Antacids; D002119:Calcium Carbonate