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The Effect Of Celecoxib On The Perioperative Inflammatory Response In Colon Cancer Patients - A Double-Blind Placebo-Controlled Trial

18 Years
75 Years
Not Enrolling
Colorectal Cancer, Colon Cancer

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Trial Information

The Effect Of Celecoxib On The Perioperative Inflammatory Response In Colon Cancer Patients - A Double-Blind Placebo-Controlled Trial

This study is the first to assess the perioperative time course of systemic inflammation and
immunity in colon cancer patients and evaluate the effect of anti-inflammatory treatment
with celecoxib on this response. In addition, evaluation of the effect of short-term
preoperative administration of celecoxib on tumor immunogenicity will help us to understand
how tumor-enhancing inflammation and anti-tumor immunity can be differentially affected by
COX-2 inhibitors. The knowledge gained as a result of this research will help us to set up
the infrastructure for a method to monitor the immunoinflammatory status of colon cancer
patients with a longer term goal of designing interventions to suppress tumor-enhancing
inflammation and vitalize anti-tumor immunity in the perioperative period. The long-term
objective is to use these novel tools in order to improve cancer-specific survival in
patients with colon cancer after primary tumor resection.

Inclusion Criteria:

- Colon cancer patients with no evidence of metastasis in distant organs (i.e., TNM stage
I-III), who are

- between 18 and 75 years old,

- have a body mass index (BMI) between 18 and 35 kg/m^2,

- and are eligible for laparoscopically-assisted colectomy for primary tumor resection.

- Patients must have the ability to understand and the willingness to sign a written
informed consent document.

Exclusion Criteria:

- A history of allergic-type reactions to celecoxib or sulphonamides,

- a history of asthma, skin reactions or other allergic reactions to aspirin or other

- a history of thromboembolic event (cerebrovascular accident, transient ischemic

- unstable angina, myocardial infarction, deep vein thrombosis, or pulmonary embolism),

- renal insufficiency (defined by a serum creatinine level > 1.5 mg/dL or blood urea
nitrogen level > 22 mg/dL),

- active gastrointestinal bleeding in the 60 days before surgery,

- alcohol or drug abuse, and

- previous chemotherapy or abdominal/pelvic radiation therapy.

- After randomization, other exclusion criteria will include a surgical procedure
longer than 6 h, inability to extubate the trachea within 4 h after operation,
evidence of a new postoperative myocardial infarction, abnormal postoperative mental
status or any new neurologic deficit, significant postoperative bleeding (with a
hemoglobin level < 7.5 g/dL), requiring blood transfusion, or a urine output of less
than 30 mL/h.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Tumor sample - Analyzed for TCR Repertoire and Global Transcription Profiling

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Anthony Doufas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

January 2011

Completion Date:

May 2011

Related Keywords:

  • Colorectal Cancer
  • Colon Cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms



Stanford University School of MedicineStanford, California  94305-5317