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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT01709487
First received: October 12, 2012
Last updated: February 23, 2016
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 ]

Enrollment: 19
Study Start Date: May 2010
Study Completion Date: October 2015
Primary Completion Date: October 2015 (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   (Adult, Senior)
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
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 
Study First Received: October 12, 2012
Last Updated: February 23, 2016
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
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

ClinicalTrials.gov processed this record on August 23, 2016