Back to resultsPreoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Indomethacin, celecoxib, esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring MHC, CTLs, Colon carcinoma, NSAID, Survival
Eligibility Criteria
Inclusion Criteria:
- Colon carcinoma scheduled for curative operation
Exclusion Criteria:
- Diabetes, steroid medication, liver and kidney impairment
Sites / Locations
- Department of Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Drug
SHAM
Arm Description
Treatment with indomethacin or celecoxib
Sham treatment
Outcomes
Primary Outcome Measures
Immune reactivity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00473980
Brief Title
Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients
Official Title
Preoperative Treatment With NSAID in Colorectal Cancer Patients in Relationship to Tumor Host Reactions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Göteborg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
MHC, CTLs, Colon carcinoma, NSAID, Survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug
Arm Type
Experimental
Arm Description
Treatment with indomethacin or celecoxib
Arm Title
SHAM
Arm Type
Sham Comparator
Arm Description
Sham treatment
Intervention Type
Drug
Intervention Name(s)
Indomethacin, celecoxib, esomeprazole
Primary Outcome Measure Information:
Title
Immune reactivity
Time Frame
Acute evaluations
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Colon carcinoma scheduled for curative operation
Exclusion Criteria:
Diabetes, steroid medication, liver and kidney impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Lundholm, MD, prof
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery
City
Göteborg
ZIP/Postal Code
SE 41345
Country
Sweden
12. IPD Sharing Statement
Links:
URL
http://www.gu.se
Description
Göteborg University
Learn more about this trial
Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients
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