Clinical pharmacoloGy of platinUm-based hyperThermic intraperitoneal chemotherapy: exploration of the impact of flushing on tumOur, systemic and personnel eXposure

Completed

• Conditions: peritoneale carcinomatose; peritoneal cancer; 10017991; 10017998

• Registration Number: NL-OMON46544
• Lead Sponsor: Afdeling Apotheek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2020-03-20
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1. Patients with a confirmed diagnosis of preoperatively identified primary or recurrent peritoneal carcinomatosis of colorectal origin who are planned for HIPEC treatment with oxaliplatin according to routine clinical care
2. Patient is at least 18 at the day of screening.
3. Patient is able and willing to sign the lnformed Consent Form.
4. Patient is able and willing to follow protocol requirements.

Exclusion Criteria

There are no specific exclusion criteria.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in tissue platinum exposure before and<br /><br>after flushing.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameter:<br /><br>- wound exudate platinum concentration and the differences between both groups<br /><br>- systemic unbound platinum exposure (AUC) and the differences between both<br /><br>groups<br /><br>- wound exudate platinum concentration<br /><br>- the degree of cytoreduction expressed as the PCI-score</p><br>