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

NCT01575730 | Completed Phase 2 DMC

• 2 other identifiers: 2012/2372012-000701-77
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Carcinomatosis

Keywords

Peritoneal carcinomatosis from colorectal or appendiceal origin

Outcome Measures

Primary Outcomes (6)

• Morbidity

  Scoring of postoperative morbidity according to the Dindo-Clavien system

  Until discharge or within 30 days

• Mortality

  The number of deaths will be recorded.

  Until discharge or within 30 days

• Area under the perfusate concentration versus time curve (AUC) of platinum

  Measurements of platinum in perfusate samples on the high dose interventions.

  Before addition of chemotherapy, at 10, 20 and 30 minutes after addition of chemotherapy

• Area under the perfusate concentration versus time curve (AUC) of platinum

  Measurements of platinum in perfusate samples on the low dose intervention.

  Before addition of chemotherapy, at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after addition of chemotherapy

• Area under the plasma concentration versus time curve (AUC) of platinum

  Measurements of platinum in perfusate samples on the high dose interventions.

  Before addition of chemotherapy, at 10, 20, 30,45, 60, 90 minutes and 2, 4, 8, 12, 18, 24 hours after addition of chemotherapy

• Area under the plasma concentration versus time curve (AUC) of platinum

  Measurements of platinum in plasma samples on the low dose intervention.

  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 Outcomes (1)

• Tissue Concentration (Cmax) of Platinum

  after 30 or 90 minutes

Study Arms (3)

Oxaliplatin 37°C, high dose, 30 minutes

ACTIVE COMPARATOR

Procedure: Hyperthermic intraoperative Peritoneal Chemoperfusion

Oxaliplatin 41 °C, high dose, 30 minutes

PLACEBO COMPARATOR

Procedure: Hyperthermic intraoperative Peritoneal Chemoperfusion

Oxaliplatin 37°C, low dose, 90 minutes

ACTIVE COMPARATOR

Drug: Hyperthermic intraoperative Peritoneal Chemoperfusion

Interventions

Hyperthermic intraoperative Peritoneal Chemoperfusion PROCEDURE

Dose: 460 mg/m², duration: 30 minutes, temperature 37°C

Oxaliplatin 37°C, high dose, 30 minutes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with peritoneal carcinomatosis from colorectal origin (including appendiceal mucinous neoplasms and the pseudomyxoma syndromes) amenable for cytoreduction and HIPEC.

You may not qualify if:

• No written informed consent
• Irresectable and/or metastatic disease found during surgery
• Known allergy to oxaliplatin

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Study Officials

• Wim P Ceelen, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 11, 2012
• Study Start: May 21, 2012
• Primary Completion: March 18, 2013
• Study Completion: March 18, 2013
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

BE (1)