SWOG S0820

A double-blind placebo-controlled trial of eflornithine and sulindac to prevent recurrence of high risk adenomas and second primary colorectal cancers in patients with stage 0-III colon or rectal cancer, Phase III- preventing adenomas of the colon with eflornithine and sulindac (PACES)

NCT01349881

Colon, Colorectal, CRC, Rectal

Stage 2

Adjuvant, Preventative

N/A

eflornithine, sulindac

ornothine-decarboxylase inhibitor (eflornithine), NSAID (sulindac)

Ari VanderWalde, M.D.

SWOG

Phase 3

Closed to Accrual

https://www.clinicaltrials.gov/ct2/show/NCT01349881

History of Stage 0, I, II, or III colon or rectal cancer
Primary resection at least 274 days (~9 months)
Primary resection no more than 465 days (~15 months) prior
No prior radiation therapy
No mid-low rectal CA
No resection >40cm in size
Adjuvant chemo must have been completed (if given) at least 30 days prior
CT scan performed at least 180 days since colon resection
No h/o FAP, HNPCC, or IBD
No other cancer within 5 years
No plan or current receipt of chronic steroids, NSAIDs, or anticoagulants
Not high cardiovascular risk (no uncontrolled HTN, no h/o CVA or MI, no Class III or IV CHF, no known uncontrolled hyperlipidemia)

Primary- 3 year rate of development of high risk adenoma or 2nd primary CRC; Secondary-Total Advanced CRC rate, recurrence, high-grade dsyplasia, etc.

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Stage 0, I, II, or III colon or rectal cancer

Eflornithine (or placebo) 250mg 2tabs daily x3 years, Sulindac (or placebo) 150mg 1tab daily x3 years

placebo

Yes