Preoperative NSAID to Colorectal Cancer Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 15, 2007

Last Updated Date

May 15, 2007

Start Date ^†

December 1998

Current Primary Outcome Measures ^†

Immune reactivity [ Time Frame: Acute evaluations ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Preoperative NSAID to Colorectal Cancer Patients

Official Title ^†

Preoperative Treatment With NSAID in Colorectal Cancer Patients in Relationship to Tumor Host Reactions

Brief Summary

The study is designed to evaluate effects of NSAIDs on immune activity inside and close to tumor tissue in patients with colorectal cancer.

Detailed Description

Study and control patients are randomized to receive preoperative treatment with indomethacin or celecoxib compared to sham treatment.Tumor biopsies are taken at operation and used for analyses of tumor immunity and gene expression.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Colorectal Cancer

Intervention ^†

Drug: Indomethacin, celecoxib, esomeprazole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Colon carcinoma scheduled for curative operation

Exclusion Criteria:

Diabetes, steroid medication, liver and kidney impairment

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Sweden

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00473980

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Göteborg University

Collaborators ^††

Investigators ^†

Principal Investigator:

Kent Lundholm, MD, prof

Göteborg University

Information Provided By

Göteborg University

Verification Date

May 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.