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) | NYU Langone Health

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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)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Colorectal Cancer
Age: Between 18 years - 120 years
Gender: Male or Female

Other Inclusion Criteria:

1. Patients must have a history of Stage 0, I, II, or III colon or rectal adenocarcinoma that has been treated per standard of care with resection alone or in combination with radiation and/or chemotherapy

2. Patients are able to swallow oral medications

You may not be eligible for this study if the following are true:

1. Patients that have received total proctocolectomy.

2. Patients with a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease

3. Patients with known hypersensitivity to eflornithine or sulindac or the excipients byproducts.

4. High cardiovascular risk or uncontrolled hypertension