APACC Study:Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence

NCT00224679 | Terminated Phase 3

• 3 other identifiers: AOM 95176P951202RAF 95176
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Experimental and epidemiologic studies have suggested that aspirin intake reduces the risk for colorectal cancer. In the APACC study we randomly assigned 291 patients to daily Aspirin or Placebo for 4 years. However, the available data are not sufficient to serve as the basis for firm recommendations

Conditions

Colon Adenomas

Keywords

Colon cancer; Aspirin; Adenomas; Prevention

Outcome Measures

Primary Outcomes (1)

• Is daily soluble aspirin associated with a reduction in the risk for recurrent adenomas at 1 and 4 years after starting treatment.

Interventions

Aspirin DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are aged between 18 and 75 years At least 3 adenomas irrespective size or at least one measuring 6mm or more All subjects had a clean colon at the study entry

You may not qualify if:

• No personal history of colon cancer, no inflammatory bowel disease, no familial adenomatous polyposis, no regular use of aspirin

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Société Nationale Française de Gastroentérologie: collaborator
• Ministry of Health, France: collaborator
• Sanofi-Synthelabo: collaborator

Study Sites (1)

Hôpital COCHIN Service d'Hépato-Gastro-Entérologie

Paris, Île-de-France Region, 75014, France

Location

Related Publications (2)

• Benamouzig R, Deyra J, Martin A, Girard B, Jullian E, Piednoir B, Couturier D, Coste T, Little J, Chaussade S. Daily soluble aspirin and prevention of colorectal adenoma recurrence: one-year results of the APACC trial. Gastroenterology. 2003 Aug;125(2):328-36. doi: 10.1016/s0016-5085(03)00887-4.

  PMID: 12891533 BACKGROUND

• Benamouzig R, Uzzan B, Deyra J, Martin A, Girard B, Little J, Chaussade S; Association pour la Prevention par l'Aspirine du Cancer Colorectal Study Group (APACC). Prevention by daily soluble aspirin of colorectal adenoma recurrence: 4-year results of the APACC randomised trial. Gut. 2012 Feb;61(2):255-61. doi: 10.1136/gutjnl-2011-300113. Epub 2011 Sep 2.

  PMID: 21890814 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Adenoma

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Stanislas CHAUSSADE, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 23, 2005
• Study Start: March 1, 1997
• Study Completion: March 1, 1999
• Last Updated: June 5, 2012

Record last verified: 2006-09

Locations

FR (1)