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

Primary Purpose

Peritoneal Carcinomatosis

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Hyperthermic intraoperative Peritoneal Chemoperfusion
Hyperthermic intraoperative Peritoneal Chemoperfusion
Hyperthermic intraoperative Peritoneal Chemoperfusion
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Carcinomatosis focused on measuring Peritoneal carcinomatosis from colorectal or appendiceal origin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Oxaliplatin 37°C, high dose, 30 minutes

Oxaliplatin 41 °C, high dose, 30 minutes

Oxaliplatin 37°C, low dose, 90 minutes

Arm Description

Outcomes

Primary Outcome Measures

Morbidity
Scoring of postoperative morbidity according to the Dindo-Clavien system
Mortality
The number of deaths will be recorded.
Area under the perfusate concentration versus time curve (AUC) of platinum
Measurements of platinum in perfusate samples on the high dose interventions.
Area under the perfusate concentration versus time curve (AUC) of platinum
Measurements of platinum in perfusate samples on the low dose intervention.
Area under the plasma concentration versus time curve (AUC) of platinum
Measurements of platinum in perfusate samples on the high dose interventions.
Area under the plasma concentration versus time curve (AUC) of platinum
Measurements of platinum in plasma samples on the low dose intervention.

Secondary Outcome Measures

Tissue Concentration (Cmax) of Platinum
Platinum concentration will be measured after removal of perfusate.

Full Information

First Posted
April 6, 2012
Last Updated
December 13, 2022
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01575730
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2012 (Actual)
Primary Completion Date
March 18, 2013 (Actual)
Study Completion Date
March 18, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Carcinomatosis
Keywords
Peritoneal carcinomatosis from colorectal or appendiceal origin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxaliplatin 37°C, high dose, 30 minutes
Arm Type
Active Comparator
Arm Title
Oxaliplatin 41 °C, high dose, 30 minutes
Arm Type
Placebo Comparator
Arm Title
Oxaliplatin 37°C, low dose, 90 minutes
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Hyperthermic intraoperative Peritoneal Chemoperfusion
Intervention Description
Dose: 460 mg/m², duration: 30 minutes, temperature 37°C
Intervention Type
Procedure
Intervention Name(s)
Hyperthermic intraoperative Peritoneal Chemoperfusion
Intervention Description
Dose: 460 mg/m², duration: 30 minutes, temperature 41°C
Intervention Type
Drug
Intervention Name(s)
Hyperthermic intraoperative Peritoneal Chemoperfusion
Intervention Description
Dose: 200 mg/m², duration: 90 minutes, temperature 37°C
Primary Outcome Measure Information:
Title
Morbidity
Description
Scoring of postoperative morbidity according to the Dindo-Clavien system
Time Frame
Until discharge or within 30 days
Title
Mortality
Description
The number of deaths will be recorded.
Time Frame
Until discharge or within 30 days
Title
Area under the perfusate concentration versus time curve (AUC) of platinum
Description
Measurements of platinum in perfusate samples on the high dose interventions.
Time Frame
Before addition of chemotherapy, at 10, 20 and 30 minutes after addition of chemotherapy
Title
Area under the perfusate concentration versus time curve (AUC) of platinum
Description
Measurements of platinum in perfusate samples on the low dose intervention.
Time Frame
Before addition of chemotherapy, at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after addition of chemotherapy
Title
Area under the plasma concentration versus time curve (AUC) of platinum
Description
Measurements of platinum in perfusate samples on the high dose interventions.
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
Title
Area under the plasma concentration versus time curve (AUC) of platinum
Description
Measurements of platinum in plasma samples on the low dose intervention.
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
Secondary Outcome Measure Information:
Title
Tissue Concentration (Cmax) of Platinum
Description
Platinum concentration will be measured after removal of perfusate.
Time Frame
after 30 or 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim P Ceelen, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

Learn more about this trial

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

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