S0820, Adenoma and Second Primary Prevention Trial

Conditions

• Colorectal Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Eflornithine placebo & sulindac placebo — DRUG
  Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years
• eflornithine & sulindac placebo — DRUG
  Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years.
• Eflornithine placebo & sulindac — DRUG
  Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
• Eflornithine plus sulindac — DRUG
  Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.

Study Details

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.

Key Dates

First listed

May 9, 2011

Start date

Aug 23, 2013

Status verified

Apr 2026

Primary completion

Sep 15, 2027

Completion

Feb 1, 2032

Study Design

Enrollment

354 participants (actual)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Arms

• Placebo Comparator: eflornithine placebo & sulindac placebo
  Eflornithine placebo 2 tablets, PO, daily for 3 years. Sulindac placebo, 1 tablet, PO, daily for 3 years.
• Experimental: Eflornithine & sulindac placebo
  Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo one tablet PO daily for 3 years.
• Experimental: Eflornithine placebo & sulindac
  Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
• Experimental: Eflornithine plus sulindac
  Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.

Primary Outcome Measure

Event rate, defined as rate of high-risk adenoma or second primary colorectal cancer (CRC) [ Time Frame: 3 years after registration ]

Locations (990)

Find similar trials in Birmingham, AL

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