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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005282-39-IT

Enrollment

Registered

2014-01-28

Start date

2014-05-22

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients affected by peritoneal carcinomatosis from colorectal cancer or pseudomyxoma peritonei MedDRA version: 16.1 Level: PT Classification code 10037138 Term: Pseudomyxoma peritonei System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Cisplatino Sandoz*EV 50mg 100M Product Name: Cisplatino Sandoz*EV 50mg 100M Pharmaceutical Form: Concentrate and solvent for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological diagnosis of primary peritoneal carcinomatosis from colorectal origin orpseudomyxoma peritonei; 2. Patients submitted to complete cytoreduction with residual tumor 65 mmHg, Heart rate: 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: verify if high intra abdominal pressure during hyperthermic intraperitoneal chemotherapy could enhance tissue diffusion of cisplatin inside peritoneal residual neoplastic tissues;Secondary Objective: evaluate whether high intra abdominal pressure during hipec could: - elicit changes on pharmacokinetics of cisplatin; - impact on short term surgical outcomes (morbidity, mortality, time to resuming bowel function, in-hospital stay) ;Primary end point(s): cisplatin concentration in the neoplastic residual tissue;Timepoint(s) of evaluation of this end point: 60 minutes after the start of HIPEC	—

Measure

Time frame

Main Objective: verify if high intra abdominal pressure during hyperthermic intraperitoneal chemotherapy could enhance tissue diffusion of cisplatin inside peritoneal residual neoplastic tissues;Secondary Objective: evaluate whether high intra abdominal pressure during hipec could: - elicit changes on pharmacokinetics of cisplatin; - impact on short term surgical outcomes (morbidity, mortality, time to resuming bowel function, in-hospital stay) ;Primary end point(s): cisplatin concentration in the neoplastic residual tissue;Timepoint(s) of evaluation of this end point: 60 minutes after the start of HIPEC

—

Secondary

Measure	Time frame
Secondary end point(s): safety;Timepoint(s) of evaluation of this end point: perioperative period	—

Countries

Italy

Contacts

Public ContactSc Chirurgia Colon rettale

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

roberta.aceto@istitutotumori.mi.it390223903441

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026