Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01856322 · ClinicalTrials.gov registry record · Phase 2
Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01856322: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01856322 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01856322, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG Sulindac
- OTHER Validate assays and shipping methods
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01856322
The ClinicalTrials.gov registry entry for NCT01856322 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01856322 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01856322 about?
NCT01856322 is a clinical study titled "Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer". 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...
What is the current status of trial NCT01856322?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2013-04. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01856322?
The interventions under investigation include: Placebo (DRUG), Sulindac (DRUG), Validate assays and shipping methods (OTHER).
Who is sponsoring clinical trial NCT01856322?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.