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

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 metastasi
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.
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Author:Thorsten Götze, Salah-Eddin al- Batran, Urs Pabst, Marc Reymond, Clemens Tempfer, Wolf Otto Bechstein, Ulli Bankstahl, Ines Gockel, Alfred Königsrainer, Thomas Kraus, Stefan Paul Mönig, Beate Rau, Matthias Schwarzbach, Pompiliu Piso
URN:urn:nbn:de:hebis:30:3-503588
DOI:http://dx.doi.org/10.1515/pp-2018-0113
ISSN:2364-768X
ISSN:2364-7671
Pubmed Id:http://www.ncbi.nlm.nih.gov/pubmed?term=30911658
Parent Title (English):Pleura and peritoneum
Publisher:de Gruyter
Place of publication:Berlin ; Boston
Document Type:Article
Language:English
Year of Completion:2018
Date of first Publication:2018/06/08
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2019/06/17
Tag:intraperitoneal therapy; peritoneal carcinomatosis; pressurized intraperitoneal aerosol chemotherapy (PIPAC); upper gastrointestinal cancer
Volume:3
Issue:2, 20180113
Pagenumber:7
First Page:1
Last Page:7
Note:
This work is licensed under the Creative Commons AttributionNonCommercial-NoDerivatives 4.0 License.
HeBIS PPN:451079701
Institutes:Medizin
Dewey Decimal Classification:610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - Namensnennung-Nicht kommerziell - Keine Bearbeitung 4.0

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