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FOLFOX and celecoxib vs. FOLFOX for Patients with Resected Stage III Colon Cancer

Title Colon Cancer - FOLFOX and celecoxib vs. FOLFOX for Patients with Resected Stage III Colon Cancer
Therapeutic Area Colon Cancer, Colorectal Cancer
Principal Investigator Wasif Saif, MD
Min Age 18 Years
Gender Both
Contact Leanne Ianniello
More Information


This study is being done to determine if the addition of celecoxib to standard chemotherapy (FOLFOX) improves disease-free survival when compared to standard chemotherapy alone (FOLFOX) after surgery in patients with stage III colon cancer. This study will also look at whether receiving FOLFOX chemotherapy for 12 weeks is as good as receiving it for 24 weeks in preventing recurrence of colon cancer.

Study Details

Inclusion Criteria

  • Potential subject must have diagnosis of adenocarcimona of the colon, where the tumor has been removed
  • Potential subject must have no active lymphnode involvement (may have been removed) or metastatic disease
  • Potential subject must have adequate heart function

Exclusion Criteria

  • The use of any Non-Steroidal Anti-inflammatory Drug (NSAID) in excess of 325 mg 3x per week or 100mg per day
  • Having any other cancer within the last 5 years
  • Having a known allergy to NSAIDs, Celecoxib, or any other sulfonamide drug

Study Requirements

Participants will be in the study for up to 3 years, and then if they agree they will follow-up for another 6 years.  Participants will be randomized to one of 4 groups, which will either have 3 months of FOLFOX regimen OR 6 months of FOLFOX regimen and then have 3 years of Celecoxib OR 3 years of placebo.  Participants will know the length of FOLFOX regimen but not whether they will receive Celecoxib or placebo. During the study, participants will come in to the clinic to have physical exams, blood and urine tests, scans, and ultrasounds.
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