and the attrition rate is 5%. Therefore, the total trial size
(2660) will be sufficient to detect a 6% absolute difference
of disease free survival rate for all subjects between
the two treatments, with a two-sided logrank test of 5%
type I error and 90% power; further, our 3-year DFS
rate for colon cancer is assumed to be 65%, which is
similar to the entire group as a whole, the size of colon
cancer (2000) will be sufficient to detect a 6% absolute
difference of disease free survival rate for colon cancer
Dukes C / high risk Dukes B colon cancer or
Rectal cancer subgroups
Complete Surgical Resection of Tumor
Standard adjuvant chemotherapy +
Radiotherapy
Eligible patient
Randomisation
Aspirin
200 mg OD for 3 years
Placebo
200 mg OD for 3 years
3 monthly follow-up for 3 years
followed by
6 monthly follow-up for 2 years
3 monthly follow-up for 3 years
followed by
6 monthly follow-up for 2 years
Figure 1 CONSORT Diagram. OD, once daily.
Ali et al. Trials 2011, 12:261
http://www.trialsjournal.com/content/12/1/261
Page 4 of 8
between the two treatments, with a two-sided logrank
test of 5% type I error and 80% power.
and the attrition rate is 5%. Therefore, the total trial size(2660) will be sufficient to detect a 6% absolute differenceof disease free survival rate for all subjects betweenthe two treatments, with a two-sided logrank test of 5%type I error and 90% power; further, our 3-year DFSrate for colon cancer is assumed to be 65%, which issimilar to the entire group as a whole, the size of coloncancer (2000) will be sufficient to detect a 6% absolutedifference of disease free survival rate for colon cancerDukes C / high risk Dukes B colon cancer orRectal cancer subgroupsComplete Surgical Resection of TumorStandard adjuvant chemotherapy +RadiotherapyEligible patientRandomisationAspirin200 mg OD for 3 yearsPlacebo200 mg OD for 3 years3 monthly follow-up for 3 yearsfollowed by6 monthly follow-up for 2 years3 monthly follow-up for 3 yearsfollowed by6 monthly follow-up for 2 yearsFigure 1 CONSORT Diagram. OD, once daily.Ali et al. Trials 2011, 12:261http://www.trialsjournal.com/content/12/1/261Page 4 of 8between the two treatments, with a two-sided logranktest of 5% type I error and 80% power.
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