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

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ClinicalTrials.gov Identifier: NCT01709487
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (HIPEC) after optimal debulking.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Fallopian Tube Carcinoma Primary Peritoneal Carcinoma Procedure: HIPEC Phase 1 Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy
Study Start Date : May 2010
Primary Completion Date : October 2015
Study Completion Date : October 2015


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 3 years ]
  2. Overall survival [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • incomplete surgery poor performance status bad general condition
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709487


Locations
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Hopital de la Citadelle
Liège, Belgium, 4000
Sponsors and Collaborators
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.
More Information

Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01709487     History of Changes
Other Study ID Numbers: HIPEC
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: July 2014

Keywords provided by Jules Bordet Institute:
HIPEC
ovarian carcinoma
Bordet

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Fallopian Tube Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases