MOR-1 Expression in Colorectal Cancer and Disease-free Survival Relationship. Five-year Follow-up.

Colorectal Cancer Clinical Trial

— MOROCCO  

Official title:

Mu Opioid Receptor 1 Expression in Colorectal Cancer and Disease-free Survival Relationship (Morocco). Five-year Follow-up.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601351
• Other study ID #: ODC-MOR-2018-01
• Status: Completed
• Start date: May 4, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: December 2019
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years.

• Colorectal scheduled surgery between January 2010- December 2013.

• Colon / rectum neoplasia Stage II / III (T3 / T4 N + M0).

Exclusion Criteria:

• Stage I or Stage IV

• Non-oncological colorectal surgery

• Non-elective surgery

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• ELISA for MOR-1 expression
To evaluate MOR-1 expression differences by immunohistochemical analysis (ELISA - semiquantitative) in paraffin samples from patients with colorectal cancer stage II / III submitted scheduled colorectal surgery between the tumor tissue and the adjacent nontumorous tissue.

Locations

Country	Name	City	State
Spain	Hospital Universitario La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of MOR1.	Immunohistochemical analysis (ELISA - semiquantitative) to asses expression of MOR1 in tumor tissue and adjacent nontumorous tissue.	Six months
Primary	Disease free survival.	Disease free survival 5 years after surgery.	Five years.
Secondary	Local recurrence.	Five years follow up after surgery.	Five years.
Secondary	Lymphatic relapse.	Five years follow up after surgery.	Five years.
Secondary	Metastasis.	Reproduction or extension of the tumor to another part of the body. Five years follow up after surgery.	Five years.
Secondary	Type of recurrence (local, regional or distant).	Five years follow up after surgery.	Five years.
Secondary	Overall Survival.	Five years follow up after surgery.	Five years.
Secondary	Morphine equivalents.	Morphine equivalents consumption during perioperative period.	During surgery and up to 96 hours during the perioperative period.
Secondary	Perioperative complications.	Perioperative complications until postoperative day 28th.	28 days.