Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy

February 23, 2016 updated by: Jules Bordet Institute

Feasibility Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy

First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (HIPEC) after optimal debulking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Addition of HIPEC to the standard first line treatment of ovarian carcinoma.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Liège, Belgium, 4000
        • Hôpital de la Citadelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • stage III or only pleural stage IV ovarian carcinoma first line treatment

Exclusion Criteria:

  • incomplete surgery poor performance status bad general condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIPEC surgery with chemotherapy
  • 3 courses of pre-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks
  • Debulking surgery
  • HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery
  • 3 courses of post-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks
Procedure: HIPEC
HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality rate
Time Frame: 24 weeks
We will record the mortality rate of our interventions: 3 cycles of pre-operative chemotherapy, surgery and HIPEC, 3 cycles of post-operative chemotherapy.
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years
progression free survival
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Investigators

  • Principal Investigator: Joseph Kerger, M.D., Institut Jules Bordet, Brussels, Belgium.
  • Principal Investigator: Frédéric Goffin, M.D., Hopital de la Citadelle, Liège, Belgium.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 12, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimate)

October 18, 2012

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIPEC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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