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

Peritoneal Carcinomatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575730
• Other study ID #: 2012/237
• Secondary ID: 2012-000701-77
• Status: Completed
• Phase: Phase 2
• Start date: May 21, 2012
• Est. completion date: March 18, 2013

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 18, 2013
• Est. primary completion date: March 18, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Intervention

Procedure:
• Hyperthermic intraoperative Peritoneal Chemoperfusion
Dose: 460 mg/m², duration: 30 minutes, temperature 37°C
• 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

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Scoring of postoperative morbidity according to the Dindo-Clavien system	Until discharge or within 30 days
Primary	Mortality	The number of deaths will be recorded.	Until discharge or within 30 days
Primary	Area under the perfusate concentration versus time curve (AUC) of platinum	Measurements of platinum in perfusate samples on the high dose interventions.	Before addition of chemotherapy, at 10, 20 and 30 minutes after addition of chemotherapy
Primary	Area under the perfusate concentration versus time curve (AUC) of platinum	Measurements of platinum in perfusate samples on the low dose intervention.	Before addition of chemotherapy, at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after addition of chemotherapy
Primary	Area under the plasma concentration versus time curve (AUC) of platinum	Measurements of platinum in perfusate samples on the high dose interventions.	Before addition of chemotherapy, at 10, 20, 30,45, 60, 90 minutes and 2, 4, 8, 12, 18, 24 hours after addition of chemotherapy
Primary	Area under the plasma concentration versus time curve (AUC) of platinum	Measurements of platinum in plasma samples on the low dose intervention.	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
Secondary	Tissue Concentration (Cmax) of Platinum	Platinum concentration will be measured after removal of perfusate.	after 30 or 90 minutes

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