# S0820, Adenoma and Second Primary Prevention Trial

Source: https://onco.cc/trials/nct01349881/  
OnCo record `nct01349881` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of eflornithine (DFMO) in colorectal cancer, run by SWOG Cancer Research Network, active but no longer recruiting.

## Summary

S0820, Adenoma and Second Primary Prevention Trial is a phase 3, randomised interventional study registered as NCT01349881 by SWOG Cancer Research Network, with a registry enrolment figure of 354 participants, started 2013-08-23 and due to reach its primary completion in 2027-09-15. Interventions recorded: Eflornithine placebo & sulindac placebo; eflornithine & sulindac placebo; Eflornithine placebo & sulindac; Eflornithine plus sulindac. Conditions listed: Colorectal Neoplasms. Primary outcome: Event rate, defined as rate of high-risk adenoma or second primary colorectal cancer (CRC). Colorectal eligibility wording from the registry: "* History of Stage 0-III colon or rectal cancer with primary resection 1 year previously". Sites: United States. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-24
- Also known as: PACES
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT01349881
- Phase: 3
- Setting: 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)
- Sponsor: SWOG Cancer Research Network
- Enrolled: 354

## Sources

- ClinicalTrials.gov NCT01349881: https://clinicaltrials.gov/study/NCT01349881

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- drugs: [Eflornithine (DFMO)](https://onco.cc/drugs/eflornithine/)
- companies: [Cancer Prevention Pharmaceuticals](https://onco.cc/companies/cancer-prevention-pharmaceuticals/), [SWOG Cancer Research Network](https://onco.cc/companies/swog/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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JSON: https://onco.cc/api/v1/entities/nct01349881.json