Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 575 for:    colon cancer | ( Map: California, United States )

Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01284504
Recruitment Status : Terminated (low accrual rate; the only participant withdrew after signing consent)
First Posted : January 27, 2011
Results First Posted : December 8, 2016
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Anthony Doufas, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Colorectal Cancer
Colon Cancer
Interventions Drug: Celecoxib
Other: placebo
Enrollment 1
Recruitment Details 1 patient was consented but withdrew before treatment assignment (randomization), none were treated.
Pre-assignment Details  
Arm/Group Title Celocoxib Placebo
Hide Arm/Group Description Celecoxib: 200 mg tablet oral

placebo

placebo

Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Celecoxib Placebo Total
Hide Arm/Group Description

Celecoxib, 200 mg tab

Celecoxib: 200 mg tablet oral

placebo, tab

placebo: Placebo, tab

Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
>=65 years
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female
1
 100.0%
1
 100.0%
Male
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
1
 100.0%
1
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was accrued and withdrawn after signing consent; none were treated.
Arm/Group Title Celocoxib Placebo
Hide Arm/Group Description:
Celecoxib: 200 mg tablet oral

placebo

placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Blood Samples Taken Before Initiation of Study, Day of Surgery, Days 1 and 3 Post-op, and 30 Days Post-op. Analyzed for 50 Serum Cytokines, Cell-specific Gene Expression, and TCR Repertoire.
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was accrued and withdrawn after signing consent; none were treated.
Arm/Group Title Celocoxib Placebo
Hide Arm/Group Description:
Celecoxib: 200 mg tablet oral

placebo

placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Surveys to Evaluate Patient Pain, Fatigue, and Quality of Recovery, Recorded From Day of Surgery to 30 Days Post-op.
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was accrued and withdrawn after signing consent; none were treated.
Arm/Group Title Celocoxib Placebo
Hide Arm/Group Description:
Celecoxib: 200 mg tablet oral

placebo

placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description

Celecoxib, 200 mg tab

Celecoxib: 200 mg tablet oral

placebo, tab

placebo: Placebo, tab

All-Cause Mortality
Celecoxib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Celecoxib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Anthony Doufas, MD, PhD
Organization: Stanford University
Phone: 1-650-498-7699
Responsible Party: Anthony Doufas, Stanford University
ClinicalTrials.gov Identifier: NCT01284504     History of Changes
Other Study ID Numbers: IRB-19588
SU-10182010-7110 ( Other Identifier: SU directory )
COL0001 ( Other Identifier: OnCore )
First Submitted: January 25, 2011
First Posted: January 27, 2011
Results First Submitted: October 15, 2016
Results First Posted: December 8, 2016
Last Update Posted: March 16, 2018