The utility of Aspirin in Dukes C and High Risk Dukes B Colorectal cancer--the
ASCOLT study: study protocol for a randomized controlled trial.
Author(s): Ali R, Toh HC, Chia WK; ASCOLT Trial Investigators.
Collaborators: Deng YH, Jian X, Wang W, Roh JK, Bae AJ, Shin SJ, Raj TA, Nathan
E, Khong R, Lau F, Deniel A, Low J, Tan D, Ho GF, Mastura BM, Roslani AC, Azrif
M, Yau T, Law WL, Kurnianda J, Purwanto I, Widayati K, Soemardi A, Syafei S,
Mellinas L, Andalusia R, Noorwati S, Basir I, Abdullah M, Maengkom F, Rinaldi I,
Prajogi GB, Lopes G, Ku G, Bharwani L, Chopra A, Chang A, Tham CK, Ong S, Choo
SP, Lo SK, Koo WH, Lim HY, Tan I, Lim KH, Sim R, Dasappa L, Sadashivudu G,
Mallath M, Sharma A, Chacko RT, Sivanesan B, Rajkumar A, Ganesan TS, Sajeed A,
Ismail A, Hsieh CI, Wei PL, Juo LJ, Chao TY, Chen CM, Hsieh YY, Chang TC, Lai GM,
Su YW, Chou CM, Yen CC, Lin JK, Liu JH, Lin TC, Teng HW, Hua C, Chen HC, Chang
CS, Huang SY, Wang CC, Lin SY, Chung CY, Lin JT, Hsu SZ, Huang IP, Chen CH, Chen
CC, Huang KC, Lee JC, Lin PC, Su WC, Lin BW, Lin SC, Kullathorn T, Akewanlop C,
Dankulchai P, Chansilpa Y, Akaraviputh T, Chucheep S, Jirawat PA, Atittharnsakul
P, Tantiplachiva K, Sacdalan DL, Parreno D.
Affiliation(s): INDOX Cancer Research Network, Richard Doll building, University of Oxford
OX37LF, UK.
Publication date & source: 2011, Trials. , 12:261
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.
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