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Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.

2019-04-17 12:55:22 | BioPortfolio

Summary

This is a phase III randomized, multicenter study with two different arm:

- experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin

- comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.

Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center

Description

This is a phase III randomized, multicenter study with two different arm:

- experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin

- comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.

Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center

The HIPEC CO2 regimen will be as reported below:

mitomycin: (total dose of 35 mg/mq, physiologic solution 0.9%) administrated 50% at time 0 from start of HIPEC CO2 treatment (17.5 mg/mq), 25% (8.8 mg/mq) after 30 minutes and the last dose 25% after 60 minutes. Recommended temperature for HIPEC treatment is 41-42 °C for 90 minutes.

Adjuvant treatment consists of a 6 months chemotherapy after surgery. It is possible to choose between Oxaliplatin, Capecitabine (XELOX) or Oxaliplatin, Fluorouracil, Leucovorin (FOLFOX-4) Patients affected by CRC at high risk of developing peritoneal carcinomatosis will be randomized in the study.

Study Design

Conditions

Colorectal Neoplasms

Intervention

HIPEC CO2, Standard surgery

Status

Not yet recruiting

Source

Mario Negri Institute for Pharmacological Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-04-17T12:55:22-0400

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