Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID)... | NCT00473980

Studies
Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients

NCT00473980

Sponsor

Göteborg University

Status

Completed

Last Update Posted

Apr 2, 2012Estimated

Enrollment

28Actual

Phase

Phase 4

Conditions

Colorectal Cancer

Interventions

Indomethacin, celecoxib, esomeprazole

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1998

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

May 15, 2007

First Submission Date that Met QC Criteria

May 15, 2007

First Posted Date

May 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2012

Last Update Posted Date

Apr 2, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug	Experimental	Treatment with indomethacin or celecoxib	Drug: Indomethacin, celecoxib, esomeprazole
SHAM	Sham Comparator	Sham treatment	Drug: Indomethacin, celecoxib, esomeprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indomethacin, celecoxib, esomeprazole	Drug		Drug SHAM

Measure	Description	Time Frame
Immune reactivity		Acute evaluations

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Colon carcinoma scheduled for curative operation

Exclusion Criteria:

Diabetes, steroid medication, liver and kidney impairment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kent Lundholm, MD, prof	Göteborg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery		Gothenburg		SE 41345	Sweden

Label	URL
Göteborg University	View source

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007213	Indomethacin
D000068579	Celecoxib
D064098	Esomeprazole

Ancestor Terms

ID	Term
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided