Clinical Pharmacology of Platinum-based Hyperthermic Intraperitoneal Chemotherapy

Completed

• Conditions: Peritoneal Carcinomatosis
• Interventions: Other: HIPEC with flushing afterwards; Other: HIPEC without flushing afterwards

• Registration Number: NCT03364907
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Currently, there is a lack of knowledge on the effect of additional flushing after HIPEC on tumour platinum exposure, systemic platinum exposure and platinum concentration in drain exudate and thereby personal exposure. Therefore the investigators want to perform a study to investigate the effect of flushing after HIPEC on tumour exposure, systemic exposure and on wound exudate concentration.

Detailed Description

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) is standard care in the treatment of patients with peritoneal carcinomatosis as a result of intra-abdominal cancers. In many (inter)national centres oxaliplatin is used for the primary HIPEC treatment. Although the oxaliplatin dose of 460mg/m2 is widely accepted, the exact procedure of HIPEC differs between institutions and surgeons. Due to a great variety in the volume of the abdominal cavity, platinum concentration in the perfusate might differ between patients. Moreover, there is no consensus about the usefulness of flushing the HIPEC system with crystalloids at the end of oxaliplatin administration. Flushing is predominantly performed with the idea to minimize both systemic exposure of ultrafilterable platinum and personnel exposure to platinum contaminated exudate. On the other hand, HIPEC without flushing might increase effectiveness because intraperitoneal tumour cells are exposed to high concentrations of oxaliplatin for a longer time period. The option of flushing is based on an individual preference of the surgeon. Currently, there is a lack of knowledge on the effect of flushing on tumour platinum exposure, systemic platinum exposure and platinum concentration in drain exudate and thereby personal exposure. Therefore the investigators want to perform a study to investigate the effect of flushing after HIPEC on tumour exposure, systemic exposure and on wound exudate concentration.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-07
• Study Start: 2018-03-01
• Primary Completion: 2019-06-08
• Study Completion: 2019-12-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.

   Note: Informed consent may be obtained prior to start of the specified screening window.

   Note: Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes.

2. Age ≥ 18 years

3. Confirmed diagnosis of preoperatively identifi ed primary or recurrent peritoneal carcinomatosis (PC) of colorectal origin who are planned for HIPEC treatment with oxaliplatin according to routine clinical care

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Exclusion Criteria

1. Patients who do not achieve a cytoreduction score of CC-0 will be excluded from the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIPEC patients	HIPEC with flushing afterwards	Patients with a diagnosis of peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin.
HIPEC patients	HIPEC without flushing afterwards	Patients with a diagnosis of peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin.

Primary Outcome Measures

Name	Time	Method
change in tissue platinum exposure before and after flushing	immediately after the oxaliplatin instillate solution is withdrawn from the abdominal cavity and immediately after additional flushing is performed. This takes all place within 1 hour after the start of HIPEC.	Change in tissue platinum exposure of non-tumour peritoneal tissue sample before and after flushing with saline

Secondary Outcome Measures

Name	Time	Method
wound exudate platinum concentration	until day 3 post-HIPEC	platinum concentration in wound exudate samples will be measured in the drains
systemic exposure of total and unbound platinum	until day 3 post-HIPEC	systemic exposure of total and unbound platinum will be measured using 13 blood samples
total and unbound platinum concentration in instillate	all samples will be taken within 30 minutes during the HIPEC procedure	total and unbound platinum concentration in instillate will be measured in 3 samples of instillate solution that will be obtained during the HIPEC procedure

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Netherlands