Cytoreduction Followed by Normothermic Versus Hyperthermic Intraperitoneal Intraoperative Chemoperfusion (HIPEC): a Study in Peritoneal Carcinomatosis

Phase 2

Completed

• Conditions: Peritoneal Carcinomatosis
• Interventions: Drug: Hyperthermic intraoperative Peritoneal Chemoperfusion

• Registration Number: NCT01575730
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Study Start: 2012-05-21
• Primary Completion: 2013-03-18
• Study Completion: 2013-03-18
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patients with peritoneal carcinomatosis from colorectal origin (including appendiceal mucinous neoplasms and the pseudomyxoma syndromes) amenable for cytoreduction and HIPEC.

Exclusion Criteria

• No written informed consent
• Irresectable and/or metastatic disease found during surgery
• Known allergy to oxaliplatin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxaliplatin 41 °C, high dose, 30 minutes	Hyperthermic intraoperative Peritoneal Chemoperfusion	-
Oxaliplatin 37°C, low dose, 90 minutes	Hyperthermic intraoperative Peritoneal Chemoperfusion	-
Oxaliplatin 37°C, high dose, 30 minutes	Hyperthermic intraoperative Peritoneal Chemoperfusion	-

Primary Outcome Measures

Name	Time	Method
Morbidity	Until discharge or within 30 days	Scoring of postoperative morbidity according to the Dindo-Clavien system
Mortality	Until discharge or within 30 days	The number of deaths will be recorded.
Area under the plasma concentration versus time curve (AUC) of platinum	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.
Area under the perfusate concentration versus time curve (AUC) of platinum	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.

Secondary Outcome Measures

Name	Time	Method
Tissue Concentration (Cmax) of Platinum	after 30 or 90 minutes	Platinum concentration will be measured after removal of perfusate.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium