Please use this identifier to cite or link to this item: https://doi.org/10.1186/1745-6215-12-261
Title: The utility of Aspirin in dukes C and high risk dukes B colorectal cancer - The ASCOLT study: Study protocol for a randomized controlled trial
Authors: Ali, R
Toh, H.-C
Chia, W.-K 
Keywords: acetylsalicylic acid
placebo
acetylsalicylic acid
cyclooxygenase 2 inhibitor
article
bleeding
brain hemorrhage
cancer adjuvant therapy
cancer risk
cancer staging
cancer survival
colorectal cancer
controlled study
diarrhea
digestive system perforation
digestive system ulcer
disease free survival
dizziness
double blind procedure
drug dose reduction
drug hypersensitivity
drug withdrawal
ear disease
ear ringing
follow up
gastrointestinal hemorrhage
human
major clinical study
nausea
overall survival
randomized controlled trial
vomiting
clinical protocol
clinical trial
colorectal tumor
controlled clinical trial
sample size
Aspirin
Clinical Protocols
Colorectal Neoplasms
Cyclooxygenase 2 Inhibitors
Double-Blind Method
Humans
Sample Size
Issue Date: 2011
Publisher: BMC
Citation: Ali, R, Toh, H.-C, Chia, W.-K (2011). The utility of Aspirin in dukes C and high risk dukes B colorectal cancer - The ASCOLT study: Study protocol for a randomized controlled trial. Trials 12 : 261. ScholarBank@NUS Repository. https://doi.org/10.1186/1745-6215-12-261
Rights: Attribution 4.0 International
Abstract: Background: High quality evidence indicates that aspirin is effective in reducing colorectal polyps; and numerous epidemiological studies point towards an ability to prevent colorectal cancer. However the role of Aspirin as an adjuvant agent in patients with established cancers remains to be defined. Recently a nested case-control study within the Nurses Health cohort suggested that the initiation of Aspirin after the diagnosis of colon cancer reduced overall colorectal cancer specific mortality. Although this data is supportive of Aspirin's biological activity in this disease and possible role in adjuvant therapy, it needs to be confirmed in a randomized prospective trial.Methods/Design: We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in this patient population over placebo control. The primary endpoint of this study is Disease Free Survival and the secondary Endpoint is 5 yr Overall Survival. This study will randomize eligible patients with Dukes C or high risk Dukes B colorectal cancer, after completion of surgery and standard adjuvant chemotherapy (+/- radiation therapy for rectal cancer patients) to 200 mg Aspirin or Placebo for 3 years. Stratification factors include study centre, rectal or colon cancer stage, and type of adjuvant chemotherapy (exposed/not exposed to oxaliplatin). After randomization, patient will be followed up with 3 monthly assessments whilst on study drug and for a total of 5 years. Patients with active peptic ulcer disease, bleeding diathesis or on treatment with aspirin or anti-platelet agents will be excluded from the study.Discussion: This study aims to evaluate Aspirin's role as an adjuvant treatment in colorectal cancer. If indeed found to be beneficial, because aspirin is cheap, accessible and easy to administer, it will positively impact the lives of many individuals in Asia and globally.Trials Registration: Clinicaltrials.gov: NCT00565708. © 2011 Ali et al; licensee BioMed Central Ltd.
Source Title: Trials
URI: https://scholarbank.nus.edu.sg/handle/10635/178158
ISSN: 1745-6215
DOI: 10.1186/1745-6215-12-261
Rights: Attribution 4.0 International
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