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

N/ACompletedNCT03561948

State Scientific Centre of Coloproctology, Russian Federation90 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Colon Cancer

Interventions

Experimental groupPROCEDURE

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.

Control groupPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Colon cancer which represent cT4N0-2 M0 on the basis of preoperative examination data (CT of the chest, abdominal and pelvic organs) in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual: 2. Histologically verified adenocarcinoma of the colon. 3. Signed informed consent. Exclusion Criteria: 1. Pregnancy or lactation. 2. The presence of synchronous or metachronous malignant tumors. 3. Distant metastases to the liver, lungs, peritoneal carcinomatosis and other organs. 4. Neoadjuvant chemotherapy. 5. Suspected Lynch syndrome.

Locations (1)

State Scientific Centre of Coloproctology

Moscow, Russia

Outcomes

Primary Outcomes

Positive peritoneal lavage

Cancer cell vitality

Time frame: through study completion, an average of 1 year

Data from ClinicalTrials.gov

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