NCT01809379

Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer

Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase II Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Ruhr University of Bochum · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer

Detailed description

This study aims to investigate the therapeutic efficacy of PIPAC using doxorubicin and cisplatin in women with recurrent ovarian cancer and disease progression with peritoneal carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate (CBR) according to RECIST criteria after three cycles of PIPAC with cisplatin and doxorubicin.

Conditions

• Recurrent Ovarian Cancer

Interventions

Type	Name	Description
DRUG	chemotherapy with doxorubicin and cisplatin	intraperitoneal chemotherapy applied as an aerosol and under pressure

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-03-01
• Completion: 2014-09-01
• First posted: 2013-03-12
• Last updated: 2022-07-08

Locations

1 site across 1 country: Germany