Ghent University Hospital
Ghent, Belgium
NCT Number: NCT01575730
Peritoneal carcinomatosis from appendix or colon (large bowel) cancer is treated in suitable patients with surgery followed by instillation of heated chemotherapy inside the abdominal cavity. This procedure is termed 'Hyperthermic intraoperative Peritoneal Chemoperfusion' or HIPEC. Many center perform HIPEC with high dose oxaliplatin, a standard chemotherapy drug active against colon cancer, administered during 30 minutes at 41°C. The hypothesis of this study is, that chemoperfusion at normal (37.5°C) temperature but longer duration (90 minutes) may be safer and at least as efficient. Patients will be treated with one of three possible HIPEC regimens using oxaliplatin: high dose, 30 min, 41°C; high dose, 30 min, 37.5°C; or low dose, 90 min, 37.5°C. The outcome parameters are pharmacokinetic and pharmacodynamic: using specialized techniques, tissue penetration of chemotherapy and cancer cell kill effects will be compared in order to establish the safest and most active HIPEC regimen.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Ghent, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dose: 460 mg/m², duration: 30 minutes, temperature 37°C
Dose: 200 mg/m², duration: 90 minutes, temperature 37°C
Time frame: Until discharge or within 30 days
Scoring of postoperative morbidity according to the Dindo-Clavien system
Time frame: Until discharge or within 30 days
The number of deaths will be recorded.
Time frame: Before addition of chemotherapy, at 10, 20 and 30 minutes after addition of chemotherapy
Measurements of platinum in perfusate samples on the high dose interventions.
Time frame: Before addition of chemotherapy, at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after addition of chemotherapy
Measurements of platinum in perfusate samples on the low dose intervention.
Time frame: Before addition of chemotherapy, at 10, 20, 30,45, 60, 90 minutes and 2, 4, 8, 12, 18, 24 hours after addition of chemotherapy
Measurements of platinum in perfusate samples on the high dose interventions.
Time frame: Before addition of chemotherapy, at 10, 20, 30, 40, 50, 60, 70, 80, 90 minutes and 2, 4, 8, 12, 18, 24 hours after addition of chemotherapy
Measurements of platinum in plasma samples on the low dose intervention.
Time frame: after 30 or 90 minutes
Platinum concentration will be measured after removal of perfusate.
University Hospital, Ghent
Other
Phase II Study Comparing Normothermic Versus Hyperthermic Intraoperative Chemoperfusion With Oxaliplatin in Patients With Peritoneal Metastases From Appendiceal or Colon Cancer
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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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