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Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer

NCT01856322 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2015-10-23

Study results available
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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.

Conditions

Interventions

DRUG

Sulindac

one tablet 150mg twice daily

DRUG

Placebo

One tablet twice daily

OTHER

Validate assays and shipping methods

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Marybeth S Hughes, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01856322 on ClinicalTrials.gov