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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Peritoneal Carcinomatosis

Treatments: Drug: Hyperthermic intraoperative Peritoneal Chemoperfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01575730

2012-000701-77 (EudraCT Number)

2012/237

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

45 participants in 3 patient groups, including a placebo group

Oxaliplatin 37°C, high dose, 30 minutes

Active Comparator group

Oxaliplatin 41 °C, high dose, 30 minutes

Placebo Comparator group

Oxaliplatin 37°C, low dose, 90 minutes

Active Comparator group

Treatment:

Drug: Hyperthermic intraoperative Peritoneal Chemoperfusion

Drug: Hyperthermic intraoperative Peritoneal Chemoperfusion

Drug: Hyperthermic intraoperative Peritoneal Chemoperfusion