Perioperative Intervention to Reduce Metastatic Processes in Pancreatic Cancer Patients Undergoing Curative Surgery (BC-PC)

  • STATUS
    Recruiting
  • End date
    Jan 23, 2026
  • participants needed
    210
  • sponsor
    Assaf-Harofeh Medical Center
Updated on 18 February 2022
metastasis
adenocarcinoma

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-surgical metastatic disease. A reduction in post-surgical metastatic disease will save dozens of patients in Israel annually, and tens-of thousands-around the world. The short perioperative period (days to weeks around surgery) is characterized by stress-inflammatory responses, including catecholamines (CAs, e.g., adrenaline) and prostaglandins (PGs, e.g., prostaglandin-E2) release, and induce deleterious pro-metastatic effects. Animal studies implicated excess perioperative release of CAs and PGs in facilitating cancer progression by affecting the malignant tissue, its local environment, and anti-metastatic immune functions. Congruently, our animal studies indicate that combined use of the beta-adrenergic blocker, propranolol, and the prostaglandins inhibitor, etodolac - but neither drug separately - efficiently prevented post-operative metastatic development. We recently conducted two clinical trials in three medical centers in Israel, recruiting breast (n=38) and colorectal (n=34) cancer patients, assessing the safety and short-term efficacy of perioperative propranolol and etodolac treatment. Drugs were well tolerated, without severe adverse events. Importantly, molecular/biological analyses of the excised primary tumor indicated that drug treatment caused promising anti-metastatic transformations, as well as improvements in immune and inflammatory indices. These included (i) decreased tumor cell capacity to migrate, (ii) reduced pro-metastatic capacity of the malignant tissue, and (iii) improvement in immune infiltrating into the tumor (Paper published in Clinical Cancer Research, 2017). Herein, we propose to conduct a double-blind placebo-controlled two-arm Phase II clinical trial in 210 pancreatic cancer patients undergoing curative surgery in Israel. A perioperative 35-day drug treatment will be initiated 5 days before surgery. Primary outcomes will include (i) 1-year disease-free-survival (DFS), and 5-year overall survival (OS); and (ii) biological markers in blood samples, and in the excised tumor tissue. Secondary outcomes will include safety indices and psychological measures of depression, anxiety, distress, and fatigue.

Details
Condition Pancreatic Neoplasms
Treatment Placebo, Propranolol and Etodolac
Clinical Study IdentifierNCT03838029
SponsorAssaf-Harofeh Medical Center
Last Modified on18 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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 antiinflammatory 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note