Clinical Pharmacology of Platinum-based Hyperthermic Intraperitoneal Chemotherapy

Clinical pharmacoloGy of platinUm-based hyperThermic Intraperitoneal Chemotherapy: Exploration of the Impact of Flushing on tumOur, Systemic and Personnel eXposure (GUTOX)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03364907

Acronym

GUTOX

Enrollment

Registered

2017-12-07

Start date

2018-03-01

Completion date

2019-12-30

Last updated

2020-10-20

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

Conditions

Peritoneal Carcinomatosis

Keywords

HIPEC, oxaliplatin, flushing, peritoneal carcinomatosis

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.

Interventions

OTHERHIPEC with flushing afterwards

flushing with saline fluid after HIPEC

OTHERHIPEC without flushing afterwards

NO flushing with saline fluid after HIPEC

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026