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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). 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.
Primary Outcome
Difference in circulating S100A4 transcript levels will be determined by assessing the circulating S100A4 transcript level at initial presentation versus the circulating S100A4 transcript level post resection.
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 |
Why NCT01856322 stopped before completion
NCT01856322 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01856322 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01856322's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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