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Pleura Peritoneum. 2018 Jun 8;3(2):20180113. doi: 10.1515/pp-2018-0113. eCollection 2018 Jun 1.

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in combination with standard of care chemotherapy in primarily untreated chemo naïve upper gi-adenocarcinomas with peritoneal seeding - a phase II/III trial of the AIO/CAOGI/ACO.

Author information

1
Institute of Clinical Cancer Research (IKF), UCT- University Cancer Center Frankfurt, Krankenhaus Nordwest, Frankfurt am Main, Germany.
2
Klinik für Chirurgie Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität BochumHerne, Herne, Germany.
3
Chirurgische Klinik, Universitätsklinikum Tübingen, Tübingen, Germany.
4
Klinik für Frauenheilkunde Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum, Herne, Germany.
5
Department of Surgery, Frankfurt University; Hospital, Frankfurt, Germany.
6
Klinik für Visceralchirurgie, Universitätsklinikum Leipzig, Leipzig, Germany.
7
Klinik für Chirurgie, UCT- University Cancer Center Frankfurt, Krankenhaus Nordwest, Frankfurt am Main, Germany.
8
Hôpitaux Universitaires, de Genève, Service de Chirurgie viscéral, Genève, Switzerland.
9
Charité - Universitätsmedizin Berlin, Chirurgische Klinik, Berlin, Germany.
10
Department of Surgery, Klinikum Frankfurt Höchst, Frankfurt, Germany.
11
Chirurgische Klinik, Krankenhaus Barmherzige Brüder Regensburg, Regensburg, Germany.

Abstract

Background:

Peritoneal metastasis is a common and dismal evolution of several gastrointestinal (GI) tumors, including gastric, colorectal, hepatobiliary, pancreatic, and other cancers. The therapy of peritoneal metastasis is largely palliative; with the aim of prolonging life and preserving its quality. In the meantime, a significant pharmacological advantage of intraperitoneal chemotherapy was documented in the preclinical model, and numerous clinical studies have delivered promising clinical results.

Methods:

This is a prospective, open, randomized multicenter phase III clinical study with two arms that aims to evaluate the effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) combined with systemic chemotherapy vs. intravenous systemic chemotherapy alone on patients with metastatic upper GI tumors with a peritoneal seeding. Upper GI-adenocarcinomas originated from biliary tract, pancreas and stomach, or esophago- gastric junction are eligible. Patients in the study are treated with standard of care systemic palliative chemotherapy (mFOLFOX6) vs. PIPAC with intravenous (i.v.) chemotherapy (mFOLFOX6). Patients in first line with first diagnosed peritoneal seeding are eligible. Primary outcome is progression free survival (PFS).

Conclusions:

PIPAC-procedure is explicit a palliative method but it delivers cytotoxic therapy like in hyperthermic intraperitoneal chemotherapy (HIPEC)-procedure directly to the tumor in a minimally invasive technique, without the need for consideration of the peritoneal-plasma barrier. The technique of PIPAC is minimally invasive and very gentle and the complete procedure takes only round about 45 min and, therefore, optimal in a clearly palliative situation where cure is not the goal. It is also ideal for using this approach in a first line situation, where deepest response should be achieved. The symbiosis of systemic therapy and potentially effective surgery has to be well-planned without deterioration of the patient due to aggressive way of surgery like in cytoreductive surgery (CRS)+HIPEC.

Trial registration:

EudraCT: 2018-001035-40.

KEYWORDS:

intraperitoneal therapy; peritoneal carcinomatosis; pressurized intraperitoneal aerosol chemotherapy (PIPAC); upper gastrointestinal cancer.

Conflict of interest statement

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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