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

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

Tracking Information
First Submitted Date  ICMJE April 6, 2012
First Posted Date  ICMJE April 11, 2012
Last Update Posted Date December 5, 2014
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cytoreduction Followed by Normothermic Versus Hyperthermic Intraperitoneal Intraoperative Chemoperfusion (HIPEC): a Study in Peritoneal Carcinomatosis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peritoneal Carcinomatosis
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 10, 2012)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575730
Other Study ID Numbers  ICMJE 2012/237
2012-000701-77 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE University Ghent
Investigators  ICMJE
Principal Investigator: Wim P Ceelen, MD, PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP