MedDataX Logo

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

NCT ID: NCT01575730

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-21

Study Completion Date

2013-03-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peritoneal Carcinomatosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Peritoneal carcinomatosis from colorectal or appendiceal origin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oxaliplatin 37°C, high dose, 30 minutes

Group Type ACTIVE_COMPARATOR

Hyperthermic intraoperative Peritoneal Chemoperfusion

Intervention Type PROCEDURE

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

Oxaliplatin 41 °C, high dose, 30 minutes

Group Type PLACEBO_COMPARATOR

Hyperthermic intraoperative Peritoneal Chemoperfusion

Intervention Type PROCEDURE

Dose: 460 mg/m², duration: 30 minutes, temperature 41°C

Oxaliplatin 37°C, low dose, 90 minutes

Group Type ACTIVE_COMPARATOR

Hyperthermic intraoperative Peritoneal Chemoperfusion

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hyperthermic intraoperative Peritoneal Chemoperfusion

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

Intervention Type PROCEDURE

Hyperthermic intraoperative Peritoneal Chemoperfusion

Dose: 460 mg/m², duration: 30 minutes, temperature 41°C

Intervention Type PROCEDURE

Hyperthermic intraoperative Peritoneal Chemoperfusion

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Ghent

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wim P Ceelen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ghent University Hospital

Ghent, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Related Links

Access external resources that provide additional context or updates about the study.

http://www.uzgent.be

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-000701-77

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2012/237

Identifier Type: -

Identifier Source: org_study_id