Status:
UNKNOWN
β-adrenergic Blocker and a COX2 Inhibitor for Prevention of Colorectal Cancer Recurrence
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
Tel-Aviv Sourasky Medical Center
Rabin Medical Center
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Colon and rectal cancer is the second most prevalent malignant disease in the western world, causing significant morbidity, mortality, and healthcare sources use. Treating colon and rectal cancer with...
Eligibility Criteria
Inclusion
- Patients planned for surgery for primary resection of colon and rectal cancer in curative intent.
- Single colonic or rectal carcinoma, proofed by full colonoscopy and tumor biopsy. If colonoscopy failed to reach the cecum, proximal colonic investigation will be made using contract enema or CT colonography.
- No evidence of metastatic disease prior to surgery. Minimal workup would include abdominal CT with IV contrast (or CT+liver US) and chest XR.
- Age between 18 and 75 year old.
- ASA score of 1-3
- The patient is able to understand the study objectives and procedures, able to comply with the protocol, and is capable to sign an informed consent.
Exclusion
- Patients with metastatic disease, known prior to surgery.
- Patients in whom metastatic disease is found at surgery will complete the intervention phase, followed for additional month for potential complications, and will exit the study to allow potential participation in further clinical trials.
- Patients in whom surgical resection is planned without curative intent.
- Patients with renal failure, measured by Creatinine level \>1.5
- Patients with significant heart failure (NYH 3 or higher)
- Patients with significant liver failure (known cirrhosis, Bilirubin level\>2)
- Patients suffering from asthma
- Patients with known allergy to one or more of the study medications
- Patients with known allergy to any medication from the non-steroidal anti-inflammatory drug group.
- Patients with diabetes (type 1 or 2).
- Patients treated chronically with one or more of the study medications
- Patients treated chronically with any type of Beta adrenergic blocker.
- Patients treated chronically with any type of COX inhibitor.
- Patients with second or third degree AV block.
- Patients with sinus bradycardia (patients with heart rate of less than 50).
- Patients with sick sinus syndrome.
- Patients with Prinzmetal's angina
- Patients with right sided heart failure owing to pulmonary hypertension.
- Patients with significant cardiomegaly
- Patients with (current) pheochromocytoma
- Patients with chronic Digoxin treatment
- Patients with active peptic disease
- Patients with peripheral vascular disease
- Patients with history or concomitant malignant disease of any type.
- Patients who were treated with chemotherapy in the last 10 years for any reason besides neo-adjuvant therapy for rectal cancer within the last six months.
- Pregnant woman.
- Patients participating in any other clinical trial
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2017
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00888797
Start Date
January 1 2010
End Date
January 1 2017
Last Update
July 12 2011
Active Locations (3)
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1
Rabin- Beilinson Medical Center
Petah Tikva, Israel
2
Tel Aviv-Sourasky Medical Center
Tal Aviv, Israel
3
Sheba Medical Center
Tel Litwinsky, Israel, 45858