NCT01575730

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

Phase II Study Comparing Normothermic Versus Hyperthermic Intraoperative Chemoperfusion With Oxaliplatin in Patients With Peritoneal Metastases From Appendiceal or Colon Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peritoneal Carcinomatosis

Interventions

Type	Name	Description
PROCEDURE	Hyperthermic intraoperative Peritoneal Chemoperfusion	Dose: 460 mg/m², duration: 30 minutes, temperature 37°C
PROCEDURE	Hyperthermic intraoperative Peritoneal Chemoperfusion	Dose: 460 mg/m², duration: 30 minutes, temperature 41°C
DRUG	Hyperthermic intraoperative Peritoneal Chemoperfusion	Dose: 200 mg/m², duration: 90 minutes, temperature 37°C

Timeline

• Start date: 2012-05-21
• Primary completion: 2013-03-18
• Completion: 2013-03-18
• First posted: 2012-04-11
• Last updated: 2022-12-15

Locations

1 site across 1 country: Belgium