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About
This is a phase III randomized, multicenter study with two different arm:
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
Full description
This is a phase III randomized, multicenter study with two different arm:
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.
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Inclusion criteria
Patients with histologically documented colorectal adenocarcinoma eligible for R0,
Age ≥ 18 and ≤75 years
Written informed consent
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
330 participants in 2 patient groups
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Central trial contact
Chiara Gerardi; Fabio Pacelli, MD
Data sourced from clinicaltrials.gov
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