OncoMatch/Clinical Trials/NCT03919461
Colorectal Metastasis Prevention International Trial 2
Is NCT03919461 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Propranolol and etodolac for colorectal neoplasms.
Treatment: Propranolol and etodolac — 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, animal studies conducted by the investigators 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. Two recently conducted clinical trials, conducted by the investigators, 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, the investigators propose to conduct a double-blind placebo-controlled two-arm Phase II clinical trial in 200 colorectal cancer patients undergoing curative surgery in Israel. A perioperative 20-day drug treatment will be initiated 5 days before surgery. Primary outcomes will include (i) 3-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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Disease stage
Excluded: Stage IV
No evidence of metastatic disease prior to surgery
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: chemotherapy
Exception: neo-adjuvant therapy for rectal cancer within the last six months
Lab requirements
Kidney function
renal failure, measured by creatinine level >1.5 [excluded]
Liver function
significant liver failure (known cirrhosis, Bilirubin level>2) [excluded]
Cardiac function
significant heart failure (NYHA functional class 3 or higher), bradycardia, second or third degree AV block, right sided heart failure owing to pulmonary hypertension, significant diagnosed cardiomegaly, sick sinus syndrome [all excluded]
Patients with renal failure, measured by creatinine level >1.5; significant heart failure (NYHA functional class 3 or higher); significant liver failure (known cirrhosis, Bilirubin level>2); bradycardia or second or third degree AV block; right sided heart failure owing to pulmonary hypertension; significant diagnosed cardiomegaly; sick sinus syndrome
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT03919461 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger and at least 20 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages