Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy
Phase 1
Completed
- Conditions
- Ovarian CarcinomaFallopian Tube CarcinomaPrimary Peritoneal Carcinoma
- Interventions
- Procedure: HIPEC
- Registration Number
- NCT01709487
- Lead Sponsor
- Jules Bordet Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 19
Inclusion Criteria
- stage III or only pleural stage IV ovarian carcinoma first line treatment
Exclusion Criteria
- incomplete surgery poor performance status bad general condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HIPEC surgery with chemotherapy HIPEC * 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
- Primary Outcome Measures
Name Time Method mortality rate 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
Name Time Method progression free survival 3 years Overall survival 3 years
Trial Locations
- Locations (2)
Institut Jules Bordet
🇧🇪Brussels, Belgium
Hopital de la Citadelle
🇧🇪Liège, Belgium