Colorectal CancerPhase 4NCT00473980
Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients
A Phase 4 study testing Indomethacin, celecoxib, esomeprazole in people with Colorectal Cancer, run by Göteborg University at 1 site in Sweden.
Trial summary
The study is designed to evaluate effects of NSAIDs on immune activity inside and close to tumor tissue in patients with colorectal cancer. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Indomethacin, celecoxib, esomeprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- Dec 1998to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colon carcinoma scheduled for curative operation
Who cannot join
- Diabetes, steroid medication, liver and kidney impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Treatment With NSAID in Colorectal Cancer Patients in Relationship to Tumor Host Reactions
The study is designed to evaluate effects of NSAIDs on immune activity inside and close to tumor tissue in patients with colorectal cancer.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Indomethacin, celecoxib, esomeprazole
- Keywords
- MHC, CTLs, Colon carcinoma, NSAID, Survival
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin, celecoxib, esomeprazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | Treatment with indomethacin or celecoxib Receives: Drug: Indomethacin, celecoxib, esomeprazole |
| SHAM | Sham comparator | Sham treatment Receives: Drug: Indomethacin, celecoxib, esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune reactivity
Measured: Acute evaluations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startDec 1998
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Investigators
- Kent Lundholm, MD, prof, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473980
- Sponsor's protocol ID
- kl4501122
- Status last verified
- Mar 2012
- First submitted
- 15 May 2007
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Treatment With NSAID in Colorectal Cancer Patients in Relationship to Tumor Host Reactions
- ClinicalTrials.gov ID
- NCT00473980
- Acronym / sponsor ID
- kl4501122
- Conditions
- Colorectal Cancer
- Keywords
- MHC, CTLs, Colon carcinoma, NSAID, Survival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Dec 1998
- Study completion
- May 2007 (actual)
- First posted
- 16 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: Indomethacin, celecoxib, esomeprazoleTreatment with indomethacin or celecoxib |
| SHAM | Sham comparator | Drug: Indomethacin, celecoxib, esomeprazoleSham treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colon carcinoma scheduled for curative operation
Key exclusion criteria (1 listed)
- Diabetes, steroid medication, liver and kidney impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indomethacin, celecoxib, esomeprazole | Drug | Drug, SHAM |
Primary outcome
Immune reactivity
Time frame: Acute evaluations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
- Göteborg UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kent Lundholm, MD, prof principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indomethacin, celecoxib, esomeprazole in people with Colorectal Cancer, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune reactivity (time frame: Acute evaluations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.