Preoperative NSAID to Colorectal Cancer Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

May 15, 2007

Last Updated Date

May 15, 2007

Start Date ^ICMJE

December 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Immune reactivity [ Time Frame: Acute evaluations ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Preoperative NSAID to Colorectal Cancer Patients

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT ID ^ICMJE

NCT00473980

Responsible Party

Study ID Numbers ^ICMJE

kl4501122

Study Sponsor ^ICMJE

Göteborg University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kent Lundholm, MD, prof

Göteborg University

Information Provided By

Göteborg University

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP