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 Carcinoma; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma

• 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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2012-10-12
• Study First Submitted QC: 2012-10-17
• Study First Posted: 2012-10-18
• Status Verified: 2014-07
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

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

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
Overall survival	3 years
progression free survival	3 years

Trial Locations

Locations (2)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Hopital de la Citadelle; 🇧🇪 Liège, Belgium