Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4
Primary Purpose
Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Experimental group
Control group
Sponsored by
About this trial
This is an interventional prevention trial for Colon Cancer focused on measuring intraperitoneal chemotherapy, Peritoneal Carcinomatosis, Colonic Diseases
Eligibility Criteria
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.
Sites / Locations
- State Scientific Centre of Coloproctology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
Surgery and Intraperitoneal Chemotherapy
only surgery
Outcomes
Primary Outcome Measures
Positive peritoneal lavage
Cancer cell vitality
Secondary Outcome Measures
Full Information
NCT ID
NCT03561948
First Posted
May 30, 2018
Last Updated
March 16, 2021
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
1. Study Identification
Unique Protocol Identification Number
NCT03561948
Brief Title
Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4
Official Title
Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
August 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State Scientific Centre of Coloproctology, Russian Federation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
intraperitoneal chemotherapy, Peritoneal Carcinomatosis, Colonic Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Surgery and Intraperitoneal Chemotherapy
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
only surgery
Intervention Type
Procedure
Intervention Name(s)
Experimental group
Intervention Description
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
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive peritoneal lavage
Description
Cancer cell vitality
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
State Scientific Centre of Coloproctology
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4
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