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

NCT01575730 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-12-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Wim P Ceelen, MD, PhD · University Hospital, Ghent

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-21
Primary Completion
2013-03-18
Completion
2013-03-18

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01575730 on ClinicalTrials.gov