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Completed

NCT Number: NCT01575730

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ghent University Hospital

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperthermic intraoperative Peritoneal Chemoperfusion

Procedure

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

Hyperthermic intraoperative Peritoneal Chemoperfusion

Drug

Dose: 200 mg/m², duration: 90 minutes, temperature 37°C

Primary outcomes

  1. Morbidity

    Time frame: Until discharge or within 30 days

    Scoring of postoperative morbidity according to the Dindo-Clavien system

  2. Mortality

    Time frame: Until discharge or within 30 days

    The number of deaths will be recorded.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Tissue Concentration (Cmax) of Platinum

    Time frame: after 30 or 90 minutes

    Platinum concentration will be measured after removal of perfusate.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

Phase II Study Comparing Normothermic Versus Hyperthermic Intraoperative Chemoperfusion With Oxaliplatin in Patients With Peritoneal Metastases From Appendiceal or Colon Cancer

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 11, 2012
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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