Brief Title
Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy
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
Brief Summary
First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (HIPEC) after optimal debulking.
Detailed Description
Addition of HIPEC to the standard first line treatment of ovarian carcinoma.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
mortality rate
Secondary Outcome
progression free survival
Condition
Ovarian Carcinoma
Intervention
HIPEC
Study Arms / Comparison Groups
HIPEC surgery with chemotherapy
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
19
Start Date
May 2010
Completion Date
October 2015
Primary Completion Date
October 2015
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Joseph Kerger, M.D., ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT01709487
Organization ID
HIPEC
Responsible Party
Sponsor
Study Sponsor
Jules Bordet Institute
Study Sponsor
Joseph Kerger, M.D., Principal Investigator, Institut Jules Bordet, Brussels, Belgium.
Verification Date
July 2014