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

• ClinicalTrials.gov Identifier: NCT01575730
• Recruitment Status: Unknown
• First Posted: April 11, 2012
• Last Update Posted: December 5, 2014
• Sponsor: University Hospital, Ghent
• Collaborator: University Ghent
• Information provided by (Responsible Party): University Hospital, Ghent

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peritoneal Carcinomatosis	Procedure: Hyperthermic intraoperative Peritoneal Chemoperfusion; Drug: Hyperthermic intraoperative Peritoneal Chemoperfusion	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study Comparing Normothermic Versus Hyperthermic Intraoperative Chemoperfusion With Oxaliplatin in Patients With Peritoneal Metastases From Appendiceal or Colon Cancer
• Study Start Date: June 2012
• Estimated Primary Completion Date: July 2015
• Estimated Study Completion Date: July 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Oxaliplatin 37°C, high dose, 30 minutes	Procedure: Hyperthermic intraoperative Peritoneal Chemoperfusion; Dose: 460 mg/m², duration: 30 minutes, temperature 37°C
Placebo Comparator: Oxaliplatin 41 °C, high dose, 30 minutes	Procedure: Hyperthermic intraoperative Peritoneal Chemoperfusion; Dose: 460 mg/m², duration: 30 minutes, temperature 41°C
Active Comparator: Oxaliplatin 37°C, low dose, 90 minutes	Drug: Hyperthermic intraoperative Peritoneal Chemoperfusion; Dose: 200 mg/m², duration: 90 minutes, temperature 37°C

Outcome Measures

Primary Outcome Measures :

1. Morbidity [ Time Frame: Until discharge or within 30 days ]
   Scoring of postoperative morbidity according to the Dindo-Clavien system
2. Mortality [ Time Frame: Until discharge or within 30 days ]
   The number of deaths will be recorded.
3. Area under the perfusate concentration versus time curve (AUC) of platinum [ Time Frame: Before addition of chemotherapy, at 10, 20 and 30 minutes after addition of chemotherapy ]
   Measurements of platinum in perfusate samples on the high dose interventions.
4. Area under the perfusate concentration versus time curve (AUC) of platinum [ Time Frame: 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.
5. Area under the plasma concentration versus time curve (AUC) of platinum [ Time Frame: Before addition of chemotherapy, at 10, 20, 30,45, 60, 90 minutes and 2, 4, 8, 12, 18, 24 hours after addition of chemotherapy ]
   Measurements of platinum in perfusate samples on the high dose interventions.
6. Area under the plasma concentration versus time curve (AUC) of platinum [ Time Frame: 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.

Secondary Outcome Measures :

1. Tissue Concentration (Cmax) of Platinum [ Time Frame: after 30 or 90 minutes ]
   Platinum concentration will be measured after removal of perfusate.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Belgium

Ghent University Hospital; Recruiting

Ghent, Belgium

Contact: Wim P Ceelen, MD, PhD wim.ceelen@ugent.be

Principal Investigator: Wim P Ceelen, MD, PhD

Sponsors and Collaborators

University Hospital, Ghent

University Ghent

Investigators

• Principal Investigator: Wim P Ceelen, MD, PhD; University Hospital, Ghent

More Information

Additional Information:

Related Info 

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT01575730
• Other Study ID Numbers: 2012/237; 2012-000701-77 ( EudraCT Number )
• First Posted: April 11, 2012
• Last Update Posted: December 5, 2014
• Last Verified: December 2014

Keywords provided by University Hospital, Ghent:

Peritoneal carcinomatosis from colorectal or appendiceal origin

Additional relevant MeSH terms:

Carcinoma; Peritoneal Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Abdominal Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases