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

Phase 2

Completed

• Conditions: Recurrent Ovarian Cancer
• Interventions: Drug: chemotherapy with doxorubicin and cisplatin

• Registration Number: NCT01809379
• Lead Sponsor: Ruhr University of Bochum

Brief 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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-08
• Study First Posted: 2013-03-12
• Primary Completion: 2014-03
• Study Completion: 2014-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

• at least 2 lines of previous chemotherapy
• recurrent ovarian cancer
• patient is mobile
• informed consent

Exclusion Criteria

• ileus
• necessity of parenteral nutrition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intraperitoneal chemotherapy	chemotherapy with doxorubicin and cisplatin	Intraperitoneal chemotherapy with cisplatin at a dose of 7.5 mg/m2 body surface in a 150 ml NaCl 0.9% and doxorubicin at a dose of 1.5 mg/m2 body surface in a 50 ml NaCl 0.9% solution with a flow of 30 ml/min and a max upstream pressure of 200 psi.

Primary Outcome Measures

Name	Time	Method
Clinical Benefit Rate	6 months	The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria.

Secondary Outcome Measures

Name	Time	Method
safety	6 months	left heart ejection fraction, neurological status, laparoscopy complications intraoperative, laparoscopy complications postoperative until hospital discharge, re-admission to hospital, death

Trial Locations

Locations (1)

Ruhr University Bochum; 🇩🇪 Bochum, NRW, Germany