Colorectal Cancer Clinical Trial
Official title:
Mu Opioid Receptor 1 Expression in Colorectal Cancer and Disease-free Survival Relationship (Morocco). Five-year Follow-up.
Colorectal cancer (CRC) is a global burden and one of the most frequent types of cancer.
Colorectal cancer therapy is complex and surgery remains the cornerstone for its treatment,
combined with chemotherapy and radiotherapy. At diagnosis time, stage II / III is the
predominant . There is a growing interest on the potential effect of perioperative anesthetic
management on cancer growth and spread. Preclinical studies suggest that opioids could
promote direct tumor growth, angiogenesis, metastasis and immunosuppression of cellular and
humoral responses, mainly mediated by Mu opioid receptor 1 (MOR-1) activation. Association
between increased expression of MOR-1and or perioperative opioids use and shorter DFS or OS
has been demonstrated in lung, prostate, gastric and esophagus cancers. Furthermore a pooled
analysis suggested that methylnaltrexone, a peripherally acting Mu-opioid receptor antagonist
(PAMORA) was associated with increased survival in patients with advanced cancer.
Thus, the expression of the MOR-1 is an indicator of poor prognosis in some cancer types, but
its relevance in colon cancer is unknown. The hypothesis of this study is that the increased
MOR-1expression in tumor samples from colorectal cancer could be associated to poor disease
free survival.
These findings would be of great clinical relevance in order to avoid perioperative opioid
use in oncological patients. Moreover PAMORAs could be a valuable tool in perioperative
antitumor treatment, since currently these drugs are currently used with confirmed
tolerability and low adverse effects in the management of opioid-induced constipation (Opioid
Induced Constipation-OIC). Besides MOR 1 expression could constitute a biomarker that guide
the investigators to perform neoadjuvant therapy.
PRIMARY OBJECTIVES:
To evaluate the association between Mu opioid receptor 1 (MOR-1) expression in patients with
colorectal cancer stage II / III submitted to scheduled curative surgery and disease-free
survival (DFS) five years follow up after surgery.
SECONDARY OBJECTIVES:
To evaluate the association between the MOR-1 expression in patients with colorectal cancer
stage II / III undergoing scheduled curative surgery and overall survival (OS) five years
follow up after surgery.
To evaluate the association between MOR-1 expression in patients with colorectal cancer stage
II / III submitted to scheduled curative surgery and perioperative complications until
postoperative day 28th after surgery.
To evaluate the association between perioperative opioids dose (morphine equivalents) and
disease-free survival/overall survival until five years after surgery.
To evaluate MOR-1 expression differences in paraffin samples from patients with colorectal
cancer stage II / III submitted scheduled colorectal surgery between the tumor tissue and the
adjacent nontumorous tissue.
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