Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Colorectal Cancer, Liver Metastasis, Colorectal Adenocarcinoma
In brief
Background: \- Some types of inflammation may increase the risk of cancers in the intestinal track. Because of this possibility, anti-inflammatory drugs may be able to prevent tumor growth and spread. One such drug, sulindac, may be helpful to study. Researchers want to see if people who are having surgery to remove intestinal tumors from advanced colorectal cancer will benefit from sulindac. It will be tested against a placebo. Objectives: \- To see if sulindac can improve treatment outcomes in people who are having surgery for advanced colorectal cancer. Eligibility: \- Individuals at least 18 years of age who are having surgery for advanced colorectal cancer. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be collected. Imaging studies and heart and lung function tests may also be given. * Participants will be separated into two groups. One group will take sulindac. The other will take a placebo. * Participants will take sulindac or placebo twice daily from about 2 to 3 weeks before the scheduled surgery. Seven days before the surgery, they will stop taking the pills. * Participants will have surgery to remove their tumors. The surgery will also remove affected organ tissue. * Participants will start to take the pills again once they have recovered from surgery. They will continue taking the sulindac or placebo twice a day for 3 years, or for as long as the tumors do not return.
Key facts
- Study ID
- NCT01856322
- Run by
- National Cancer Institute (NCI)
- People needed
- 3
- Starts
- 2013-04-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2015-10-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Women of child-bearing potential who are pregnant or breast feeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant.
- Active systemic infections, coagulation disorders or other major medical illnesses precluding major surgery.
- Patients receiving warfarin anticoagulation, who cannot be transferred to other agents, such as low molecular weight heparins, anti-factor Xa (anti-Xa) agents, etc.
- Active bleeding disorders
- Patients with uncontrolled hypertension (would suggest: systolic blood pressure (SBP)> 155, diastolic blood pressure (DBP)> 90), unstable coronary disease (unstable angina, evidence of congestive heart failure (CHF), or myocardial infarction (MI) within 6-12 months of study)
- Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy, or radiologic studies or with evidence of moderate to severe ascites.
- Prior history of gastrointestinal (GI) bleeding unrelated to a cancer diagnosis
- Note: Patients who have a normal upper and lower endoscopy may be enrolled at the discretion of the principal investigator (PI).
- Renal insufficiency Discretion of principle investigator.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.