Status:
RECRUITING
Perioperative Intervention to Reduce Metastatic Processes in Pancreatic Cancer Patients Undergoing Curative Surgery
Lead Sponsor:
Assaf-Harofeh Medical Center
Collaborating Sponsors:
Sheba Medical Center
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
In Israel, of the \~1000 patients diagnosed annually with pancreatic cancer (PC), approximately 250 (25 percent) will be eligible for curative surgery, of which 80 percent will succumb to post-surgica...
Eligibility Criteria
Inclusion
- Newly diagnosed Stage I or II adenocarcinoma of the head, neck, or uncinated- process of the pancreas.
- Surgically resectable disease (R0 or R1) by spiral CT chest and abdomen scan, No distant metastases
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Signed informed consent form
- Willing and able to comply with study procedures
- Men and women from age 20 up to age 80
Exclusion
- Patients with metastatic disease, known prior to surgery
- Patients with history or concomitant malignant disease of any type (except for the current pancreatic cancer
- Patients who were treated with chemotherapy in the last 10 years for any reason
- Patients in whom surgical resection is planned without curative intent
- Patients exhibiting levels Carbohydrate antigen (CA) 19-9 above 500
- Patients with renal failure, measured by creatinine level \>1.5
- Patients with significant heart failure (NYHA functional class 3 or higher),
- Patients with significant liver failure (known cirrhosis)
- Patients suffering from active asthma
- Patients with known allergy to any medication from the non-steroidal anti- inflammatory or beta-blockers drug group
- Patients treated chronically with any type of a beta-adrenergic blocker or a cyclooxygenase (COX) inhibitor
- Patients with bradycardia or second or third degree atrioventricular block (AV) block
- Patients with a history of cerebrovascular accident (CVA) or established diagnosed transient ischemic attack (TIA)
- Patients with prinzmetal's angina
- Patients with right sided heart failure owing to pulmonary hypertension
- Patients with significant diagnosed cardiomegaly
- Patients with (current) pheochromocytoma
- Patients with chronic Digoxin treatment
- Patients with active peptic disease
- Patients with peripheral vascular disease
- Pregnant woman
- Special population with impaired judgment
- Patients currently actively participating in any other clinical trial
- contraindication for Whipple procedure
- Patients suffering from sick sinus syndrome
- Patients with borderline resectable tumors, as defined by one of the following:
- an infiltration \>180° of the portal vein
- abutment of the tumor to the superior mesenteric artery
- infiltration of the superior mesenteric artery or the celiac trunk
Key Trial Info
Start Date :
November 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT03838029
Start Date
November 20 2019
End Date
January 1 2026
Last Update
November 20 2019
Active Locations (3)
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1
Sourasky Medical Center
Tel Aviv, Israel, 6423906
2
Sheba Medical Center
Tel Litwinsky, Israel, 45858
3
Asaf Harofeh Medical Center
Ẕerifin, Israel, 70300