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

State Scientific Centre of Coloproctology, Russian Federation

Status: Completed

Conditions: Colon Cancer

Treatments: Procedure: Experimental group; Procedure: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03561948

13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

Surgery and Intraperitoneal Chemotherapy

Treatment:

Procedure: Experimental group

Control group

Placebo Comparator group

Description:

only surgery

Treatment:

Procedure: Control group