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

This study is currently recruiting participants.
Verified October 2012 by University Hospital, Ghent
Sponsor:
Collaborator:
University Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01575730
First received: April 6, 2012
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Peritoneal Carcinomatosis
Procedure: Hyperthermic intraoperative Peritoneal Chemoperfusion
Drug: Hyperthermic intraoperative Peritoneal Chemoperfusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Morbidity [ Time Frame: Until discharge or within 30 days ] [ Designated as safety issue: Yes ]
    Scoring of postoperative morbidity according to the Dindo-Clavien system

  • Mortality [ Time Frame: Until discharge or within 30 days ] [ Designated as safety issue: Yes ]
    The number of deaths will be recorded.

  • 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 ] [ Designated as safety issue: Yes ]
    Measurements of platinum in perfusate samples on the high dose interventions.

  • 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 ] [ Designated as safety issue: Yes ]
    Measurements of platinum in perfusate samples on the low dose intervention.

  • 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 ] [ Designated as safety issue: Yes ]
    Measurements of platinum in perfusate samples on the high dose interventions.

  • 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 ] [ Designated as safety issue: Yes ]
    Measurements of platinum in plasma samples on the low dose intervention.


Secondary Outcome Measures:
  • Tissue Concentration (Cmax) of Platinum [ Time Frame: after 30 or 90 minutes ] [ Designated as safety issue: Yes ]
    Platinum concentration will be measured after removal of perfusate.


Estimated Enrollment: 24
Study Start Date: June 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575730

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 Ghent University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01575730     History of Changes
Other Study ID Numbers: 2012/237, 2012-000701-77
Study First Received: April 6, 2012
Last Updated: October 29, 2012
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:
Peritoneal carcinomatosis from colorectal or appendiceal origin

Additional relevant MeSH terms:
Fever
Carcinoma
Body Temperature Changes
Signs and Symptoms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014