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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561948
• Other study ID #: 13
• Status: Completed
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: August 10, 2020

Study information

• Verified date: March 2021
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 10, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Russian Federation	State Scientific Centre of Coloproctology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive peritoneal lavage	Cancer cell vitality	through study completion, an average of 1 year