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Trial record 9 of 3905 for:    colon cancer AND Colonic Diseases

Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer pT4

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ClinicalTrials.gov Identifier: NCT03561948
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Achkasov Sergey, State Scientific Centre of Coloproctology, Russian Federation

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 T4 Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment.

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: Experimental group Procedure: Control group Not Applicable

Detailed Description:

In the experimental group (60 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 (60 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer pT4
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : May 25, 2020
Estimated Study Completion Date : August 3, 2020

Arm Intervention/treatment
Experimental: Experimental group
Surgery and Intraperitoneal Chemotherapy
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.

Placebo Comparator: Control group
only surgery
Procedure: Control group
In the control group (60 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 Measures :
  1. Positive peritoneal lavage [ Time Frame: through study completion, an average of 1 year ]
    Cancer cell vitality



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561948


Contacts
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Contact: Sergey Achkasov, professor +74991999308 achkasovy@mail.ru

Locations
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Russian Federation
State Scientific Centre of Coloproctology Recruiting
Moscow, Russian Federation, 123423
Sponsors and Collaborators
State Scientific Centre of Coloproctology, Russian Federation

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Responsible Party: Achkasov Sergey, Professor Sc.State Scientific Centre of Coloproctology, Head of Surgical department of sugery and oncology of colon, Moscow,Russian Federation, State Scientific Centre of Coloproctology, Russian Federation
ClinicalTrials.gov Identifier: NCT03561948     History of Changes
Other Study ID Numbers: 13
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Achkasov Sergey, State Scientific Centre of Coloproctology, Russian Federation:
intraperitoneal chemotherapy
Peritoneal Carcinomatosis
Colonic Diseases

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases