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NCT Number: NCT03364907

Clinical Pharmacology of Platinum-based Hyperthermic Intraperitoneal Chemotherapy

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.

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Key information

Conditions

Peritoneal Carcinomatosis Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Flushing Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritoneal Neoplasms Signs and Symptoms Skin Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboudumc

Nijmegen, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

  • Age ≥ 18 years
  • 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

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

Treatment and study plan

HIPEC with flushing afterwards

Other

flushing with saline fluid after HIPEC

HIPEC without flushing afterwards

Other

NO flushing with saline fluid after HIPEC

Primary outcomes

  1. change in tissue platinum exposure before and after flushing

    Time frame: 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 outcomes

  1. wound exudate platinum concentration

    Time frame: until day 3 post-HIPEC

    platinum concentration in wound exudate samples will be measured in the drains

  2. systemic exposure of total and unbound platinum

    Time frame: until day 3 post-HIPEC

    systemic exposure of total and unbound platinum will be measured using 13 blood samples

  3. total and unbound platinum concentration in instillate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Acronym: GUTOX

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 7, 2017
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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