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

Tracking Information

• First Submitted Date: April 6, 2012
• First Posted Date: April 11, 2012
• Last Update Posted Date: December 5, 2014
• Study Start Date: June 2012
• Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 10, 2012)

• Morbidity [ Time Frame: Until discharge or within 30 days ]
  Scoring of postoperative morbidity according to the Dindo-Clavien system
• Mortality [ Time Frame: Until discharge or within 30 days ]
  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 ]
  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 ]
  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 ]
  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 ]
  Measurements of platinum in plasma samples on the low dose intervention.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 10, 2012)

Tissue Concentration (Cmax) of Platinum [ Time Frame: after 30 or 90 minutes ]

Platinum concentration will be measured after removal of perfusate.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cytoreduction Followed by Normothermic Versus Hyperthermic Intraperitoneal Intraoperative Chemoperfusion (HIPEC): a Study in Peritoneal Carcinomatosis
• Official Title: Phase II Study Comparing Normothermic Versus Hyperthermic Intraoperative Chemoperfusion With Oxaliplatin in Patients With Peritoneal Metastases From Appendiceal or Colon Cancer
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Peritoneal Carcinomatosis

Intervention

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

Study Arms

• Active Comparator: Oxaliplatin 37°C, high dose, 30 minutes
  Intervention: Procedure: Hyperthermic intraoperative Peritoneal Chemoperfusion
• Placebo Comparator: Oxaliplatin 41 °C, high dose, 30 minutes
  Intervention: Procedure: Hyperthermic intraoperative Peritoneal Chemoperfusion
• Active Comparator: Oxaliplatin 37°C, low dose, 90 minutes
  Intervention: Drug: Hyperthermic intraoperative Peritoneal Chemoperfusion

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 10, 2012): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2015
• Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT01575730
• Other Study ID Numbers: 2012/237; 2012-000701-77 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Ghent
• Study Sponsor: University Hospital, Ghent
• Collaborators: University Ghent

Investigators

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

• PRS Account: University Hospital, Ghent
• Verification Date: December 2014