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

Study Overview
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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.

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.

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

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: Experimental group
* Procedure: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Surgery and Intraperitoneal Chemotherapy | Procedure: Experimental group<br>* 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.<br>|
| Placebo Comparator: Control group<br>only surgery | Procedure: Control group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive peritoneal lavage | Cancer cell vitality | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraperitoneal chemotherapy, Peritoneal Carcinomatosis, Colonic Diseases