Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Jules Bordet Institute
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT01709487
First received: October 12, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Ovarian Carcinoma
Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Procedure: HIPEC
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jules Bordet Institute:

Primary Outcome Measures:
  • mortality rate [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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:
  • progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709487

Locations
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Joseph Kerger, M.D.    +3225413262    joseph.kerger@bordet.be   
Contact: Lionel Cordier    +3225413213    lionel.cordier@bordet.be   
Principal Investigator: Joseph Kerger, M.D.         
Hopital de la Citadelle Recruiting
Liège, Belgium, 4000
Contact: Frédéric Goffin, M.D.    +3242257543    fgoffin@chu.ulg.ac.be   
Principal Investigator: Frédéric Goffin, M.D.         
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

No publications provided

Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01709487     History of Changes
Other Study ID Numbers: HIPEC
Study First Received: October 12, 2012
Last Updated: July 14, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Jules Bordet Institute:
HIPEC
ovarian carcinoma
Bordet

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

ClinicalTrials.gov processed this record on November 20, 2014