Clinical Trial: S0820, Adenoma and Second Primary Prevention Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Sta

Brief 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 cancer.

Detailed Summary: The purpose of this study is to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate of high risk adenoma or second primary colorectal cancer in Stage 0, I II and III colon cancer patients. The primary hypothesis will test the main effect of each agent, as well as the comparison of placebo alone to the combination of sulindac and eflornithine.
Sponsor: Southwest Oncology Group

Current Primary Outcome: 3-year event rate after registration among Stage 0-III colon cancer patients. (An event is defined as high-risk adenoma or second primary colorectal cancer.) [ Time Frame: 3 years ]

The primary objective is to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate, defined as high risk adenoma or 2nd primary colorectal cancer, in Stage 0, I, II, and III colon cancer patients.


Original Primary Outcome: 3-year event rate after registration among Stage 0-III colon cancer patients. (An event is defined as high-risk adenoma or second primary colorectal cancer.) [ Time Frame: 3 years ]

The primary objective is to assess whether elfornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate, defined as high risk adenoma or 2nd primary colorectal cancer, in Stage 0, I, II, and III colon cancer patients.


Current Secondary Outcome:

  • Incidence of colorectal lesions with respect to high-grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, polyps >/= 0.3 cm, total advanced colorectal events or total colorectal events at 3 years. [ Time Frame: 3 years and 8 years ]
    Incidence of colorectal lesions with respect to high grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, polyps >/= 0.3 cm, total advanced colorectal events (defined as the number of patients with at least one high risk adenoma, 2nd primary colorectal cancer, colorectal cancer recurrence, or metastasis) or total colorectal cancer events (defined as the number of patients with at least one advanced colorectal event or polyp)at 3 years and 8 years.
  • Toxicity by CTCAEv.4.0 at 3 years [ Time Frame: 3 years ]
    Quantitative and qualitative toxicities at 3 years.
  • Examine interaction of treatment arm and genotype expression with respect to different outcomes. [ Time Frame: 3 years and 8 years ]
  • Interaction of intervention arm and baseline statin use with respect to 3-year event rate. [ Time Frame: 3 year ]
    Interaction of intervention arm and baseline statin use with respect to 3-year event rate will be examined.
  • Evaluate SNPs associated with decreased adenoma/second primary CRC risk and AEs [ Time Frame: 3 years and 8 years ]
    Evaluate a minimal set of tagging single nucleotide polymorphisms across multiple genes relevant to eflornithine and sulindac, in order to characterize associations with decreased adenoma/second primary CRC risk and adverse events.


Original Secondary Outcome:

  • Incidence of colorectal lesions with respect to high-grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, polyps >/= 0.3 cm, total advanced colorectal events or total colorectal events at 3 years. [ Time Frame: 3 years and 8 years ]
    Incidence of colorectal lesions with respect to high grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, polyps >/= 0.3 cm, total advanced colorectal events (defined as the number of patients with at least one high risk adenoma, 2nd primary colorectal cancer, colorectal cancer recurrence, or metastasis) or total colorectal cancer events (defined as the number of pateints with at least one advanced colorectal event or polyp)at 3 years and 8 years.
  • Toxicity by CTCAEv.4.0 at 3 years [ Time Frame: 3 years ]
    Quantitative and qualitative toxicities at 3 years.
  • Examine interaction of treatment arm and genotype expression with respect to different outcomes. [ Time Frame: 3 years and 8 years ]
  • Interaction of intervention arm and baseline statin use with respect to 3-year event rate. [ Time Frame: 3 year ]
    Interaction of intervention arm and baseline statin use with respect to 3-year event rate will be examined.
  • Evaluate SNPs associated with decreased adenoma/second primary CRC risk and AEs [ Time Frame: 3 years and 8 years ]
    Evaluate a minimal set of tagging single nucleotide polymorphisms across multiple genes relevant to eflornithine and sulindac, in order to characterize associations with decreased adenoma/second primary CRC risk and adverse events.


Information By: Southwest Oncology Group

Dates:
Date Received: May 5, 2011
Date Started: March 2013
Date Completion: June 2029
Last Updated: October 12, 2016
Last Verified: October 2016