OncoMatch/Clinical Trials/NCT03919461
Colorectal Metastasis Prevention International Trial 2
Is NCT03919461 recruiting? Yes, currently enrolling (May 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
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)
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.
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