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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01575730

Enrollment

Registered

2012-04-11

Start date

2012-05-21

Completion date

2013-03-18

Last updated

2022-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Carcinomatosis

Keywords

Peritoneal carcinomatosis from colorectal or appendiceal origin

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.

Interventions

PROCEDUREHyperthermic intraoperative Peritoneal Chemoperfusion

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Morbidity	Until discharge or within 30 days	Scoring of postoperative morbidity according to the Dindo-Clavien system
Mortality	Until discharge or within 30 days	The number of deaths will be recorded.
Area under the perfusate concentration versus time curve (AUC) of platinum	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.
Area under the plasma concentration versus time curve (AUC) of platinum	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.

Secondary

Measure	Time frame	Description
Tissue Concentration (Cmax) of Platinum	after 30 or 90 minutes	Platinum concentration will be measured after removal of perfusate.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026