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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

October 12, 2012
July 14, 2014
May 2010
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01709487 on ClinicalTrials.gov Archive Site
  • progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy
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.

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

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Carcinoma
  • Fallopian Tube Carcinoma
  • Primary Peritoneal Carcinoma
Procedure: HIPEC
HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery
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
Intervention: Procedure: HIPEC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
November 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • incomplete surgery poor performance status bad general condition
Female
18 Years and older
No
Belgium
 
NCT01709487
HIPEC
No
Jules Bordet Institute
Jules Bordet Institute
Not Provided
Principal Investigator: Joseph Kerger, M.D. Institut Jules Bordet, Brussels, Belgium.
Principal Investigator: Frédéric Goffin, M.D. Hopital de la Citadelle, Liège, Belgium.
Jules Bordet Institute
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP