NCT01575730

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

Completed Phase 2 Last updated 15 December 2022

What this trial tests

Phase 2 trial testing Hyperthermic intraoperative Peritoneal Chemoperfusion in Peritoneal Carcinomatosis in 45 participants. Completed in 18 March 2013.

Timeline

21 May 2012

Primary endpoint
18 March 2013

18 March 2013

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	21 May 2012
Primary completion	18 March 2013
Estimated completion	18 March 2013
Sites	1 location across Belgium

Drugs / interventions tested

• Hyperthermic intraoperative Peritoneal Chemoperfusion — full drug profile →
• Hyperthermic intraoperative Peritoneal Chemoperfusion — full drug profile →
• Hyperthermic intraoperative Peritoneal Chemoperfusion — full drug profile →

Conditions studied

• Peritoneal Carcinomatosis — all drugs for Peritoneal Carcinomatosis →

Sponsor

University Hospital, Ghent

Who can join

Adults 18 to 75, any sex, with Peritoneal Carcinomatosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Trial watch: Chemotherapy with immunogenic cell death inducers.
   Vacchelli E, Senovilla L, Eggermont A, Fridman WH, et al · · 2013 · cited 83× · PMID 23687621 · DOI 10.4161/onci.23510