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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01809379

Enrollment

Registered

2013-03-12

Start date

2013-02-28

Completion date

2014-09-30

Last updated

2022-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Ovarian Cancer

Keywords

ovarian cancer, recurrent, chemotherapy, intraperitoneal

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.

Interventions

DRUGchemotherapy with doxorubicin and cisplatin

intraperitoneal chemotherapy applied as an aerosol and under pressure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* ileus * necessity of parenteral nutrition

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
tumor apoptosis assessment, videolaparoscopy assessment of response, CA 125 assessment of response	6 months	various measures of response to therapy on the clinical, biochemical, and histological level

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026