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:
University Hospital, Ghent
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
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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 May 16, 2013