COMPIT - Colorectal Metastasis Prevention Israeli Trial: TS01


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Abstract

Aim:Major surgery induces physiologic changes resulting in significant immune depression and other physiologic perturbations, which maypromote metastatic development. We have recently suggested that catecholamines andprostaglandins areprominent factors associated with such postoperative effects and developed perioperative treatment usingpropranolol combined with etodolac that markedly reduced the deleterious effect of surgery on immunity and neuroendocrine indices, decreased metastatic load, and increased long-term survival rates in animal models. The aim of this study is to assess the perioperative use ofpropranolol and etodolac on tumor recurrence and on immunologic, endocrine and angiogenesis indices in colorectal cancer patients.Method:Four hundred patients undergoingprimary resection for non-metastatic colon and rectal cancer with curative intent will be randomly assigned to perioperative treatment with etodolac andpropranolol for 20 days or placebo. Both the patients and investigators will be blind to the group allocation. Follow up for cancer recurrence will include semi-annual follow up for 3 years. One hundred of these patients will alsoprovide blood samples for immunological and endocrine testing.

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