Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIPEC with flushing afterwards | Other | — | UNRESOLVED |
| HIPEC without flushing afterwards | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HIPEC patients
- description
- Patients with a diagnosis of peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin.
- interventionNames
- Other: HIPEC with flushing afterwards
- Other: HIPEC without flushing afterwards
Primary outcomes (1)
- measure
- change in tissue platinum exposure before and after flushing
- timeFrame
- immediately after the oxaliplatin instillate solution is withdrawn from the abdominal cavity and immediately after additional flushing is performed.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.
- description
- Change in tissue platinum exposure of non-tumour peritoneal tissue sample before and after flushing with saline
Secondary outcomes (3)
- measure
- wound exudate platinum concentration
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTde Jong LAW, Elekonawo FMK, Lambert M, de Gooyer JM, Verheul HMW, Burger DM, de Wilt JHW, Chatelut E, Ter Heine R, de Reuver PR, Bremers AJA, van Erp NP. Wide variation in tissue, systemic, and drain fluid exposure after oxaliplatin-based HIPEC: results of the GUTOX study. Cancer Chemother Pharmacol. 2020 Jul;86(1):141-150. doi: 10.1007/s00280-020-04107-y. Epub 2020 Jun 27. PMID 32594200