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Tracking Information | |||||
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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. |
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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. |
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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. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 28 | ||||
Completion Date | May 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 40 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Sweden | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00473980 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Göteborg University | ||||
Collaborators †† | |||||
Investigators † |
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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. |