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

Ruhr University of Bochum69 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent Ovarian Cancer

Interventions

chemotherapy with doxorubicin and cisplatinDRUG

intraperitoneal chemotherapy applied as an aerosol and under pressure

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * at least 2 lines of previous chemotherapy * recurrent ovarian cancer * patient is mobile * informed consent Exclusion Criteria: * ileus * necessity of parenteral nutrition

Locations (1)

Ruhr University Bochum

Bochum, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Clinical Benefit Rate

The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria.

Time frame: 6 months

Secondary Outcomes

safety

left heart ejection fraction, neurological status, laparoscopy complications intraoperative, laparoscopy complications postoperative until hospital discharge, re-admission to hospital, death

Time frame: 6 months

Data from ClinicalTrials.gov

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