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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2020-08-10

Brief Summary

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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.

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Detailed Description

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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

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental group

Surgery and Intraperitoneal Chemotherapy

Group Type EXPERIMENTAL

Experimental group

Intervention Type 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.

Control group

only surgery

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No