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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Dose: 460 mg/m², duration: 30 minutes, temperature 37°C
Dose: 460 mg/m², duration: 30 minutes, temperature 41°C
Dose: 200 mg/m², duration: 90 minutes, temperature 37°C
Ghent University Hospital
Ghent, Belgium
Morbidity
Scoring of postoperative morbidity according to the Dindo-Clavien system
Time frame: Until discharge or within 30 days
Mortality
The number of deaths will be recorded.
Time frame: Until discharge or within 30 days
Area under the perfusate concentration versus time curve (AUC) of platinum
Measurements of platinum in perfusate samples on the high dose interventions.
Time frame: Before addition of chemotherapy, at 10, 20 and 30 minutes after addition of chemotherapy
Area under the perfusate concentration versus time curve (AUC) of platinum
Measurements of platinum in perfusate samples on the low dose intervention.
Time frame: Before addition of chemotherapy, at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after addition of chemotherapy
Area under the plasma concentration versus time curve (AUC) of platinum
Measurements of platinum in perfusate samples on the high dose interventions.
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
Area under the plasma concentration versus time curve (AUC) of platinum
Measurements of platinum in plasma samples on the low dose intervention.
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
Tissue Concentration (Cmax) of Platinum
Platinum concentration will be measured after removal of perfusate.
Time frame: after 30 or 90 minutes
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