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S0820, Adenoma and Second Primary Prevention Trial

NCT01349881 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2026-04-02

No results posted yet for this study

Summary

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

Eflornithine placebo & sulindac placebo

Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years

DRUG

eflornithine & sulindac placebo

Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years.

DRUG

Eflornithine placebo & sulindac

Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.

DRUG

Eflornithine plus sulindac

Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer Prevention Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Jason A. Zell, D.O., MPH · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-23
Primary Completion
2027-09-15
Completion
2032-02-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01349881 on ClinicalTrials.gov