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

NCT03561948 | Completed

• 1 other identifier: 13
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Cancer

Keywords

intraperitoneal chemotherapy; Peritoneal Carcinomatosis; Colonic Diseases

Outcome Measures

Primary Outcomes (1)

• Positive peritoneal lavage

  Cancer cell vitality

  through study completion, an average of 1 year

Study Arms (2)

Experimental group

EXPERIMENTAL

Surgery and Intraperitoneal Chemotherapy

Procedure: Experimental group

Control group

PLACEBO COMPARATOR

only surgery

Procedure: Control group

Interventions

Experimental group PROCEDURE

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.

Experimental group

Control group PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Histologically verified adenocarcinoma of the colon.
• Signed informed consent.

You may not qualify if:

• Pregnancy or lactation.
• The presence of synchronous or metachronous malignant tumors.
• Distant metastases to the liver, lungs, peritoneal carcinomatosis and other organs.
• Neoadjuvant chemotherapy.
• Suspected Lynch syndrome.

Sponsors & Collaborators

• State Scientific Centre of Coloproctology, Russian Federation: lead

Study Sites (1)

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

Location

MeSH Terms

Conditions

Colonic Neoplasms; Peritoneal Neoplasms; Colonic Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Sc.State Scientific Centre of Coloproctology, Head of Surgical department of sugery and oncology of colon, Moscow,Russian Federation

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 19, 2018
• Study Start: January 9, 2018
• Primary Completion: August 5, 2020
• Study Completion: August 10, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)