NCT03561948

Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: State Scientific Centre of Coloproctology, Russian Federation · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised controlled study aims to determine the oncological effectiveness of adjuvant HIPEC, using intraperitoneal Mytomicin C following a curative resection of a cT4 Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment.

Detailed description

In the experimental group (50 patients) after laparotomy and revision of the abdominal cavity organs, peritoneal lavage will be performed followed by immunological examination. After performing the surgical intervention, the patient will undergo intraoperative intra-abdominal chemotherapy with mitomycin C. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination. In the control group (40 patients), after laparotomy and revision, peritoneal lavage will also be performed, followed by immunological examination. Patients of this group will not receive intraoperative intra-abdominal chemotherapy. After performing the surgical intervention, the patient will perform irrigation of the abdominal cavity with physiological saline. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
PROCEDURE	Experimental group	After performing the surgical intervention, the patient will undergo intraoperative intra-abdominal chemotherapy with mitomycin C. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.
PROCEDURE	Control group	In the control group (40 patients), after laparotomy and revision, peritoneal lavage will also be performed with subsequent immunological examination. Patients of this group will not receive intraperitoneal chemotherapy. After performing the surgical intervention, the patient will be irrigation of the abdominal cavity with physiological saline. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.

Timeline

• Start date: 2018-01-09
• Primary completion: 2020-08-05
• Completion: 2020-08-10
• First posted: 2018-06-19
• Last updated: 2021-03-19

Locations

1 site across 1 country: Russia