Effects of high Intra-abdominal pressure on tissue diffusion and pharmacokinectics of cisplatin during HIPEC

Phase 1

• Conditions: patients affected by peritoneal carcinomatosis from colorectal cancer orpseudomyxoma peritonei; MedDRA version: 16.1Level: PTClassification code 10037138Term: Pseudomyxoma peritoneiSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-005282-39-IT
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-28
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Histological diagnosis of primary peritoneal carcinomatosis from
colorectal origin orpseudomyxoma peritonei;
2. Patients submitted to complete cytoreduction with residual tumor
<2.5 mm;
3. Patients at the end of cytoreduction should present the laboratorial
and hemodynamic parameters set as followings: Mean arterial pressure > 65
mmHg, Heart rate: < 100 bpm, Central venous pressure > 4mmHg, Cardiac index >
2.2, SvcO2 > 72%, and haemoglobin > 8,0 gr/dl.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

age>75 years, patients that does not give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified