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BMC Cancer
Published in: BMC Cancer 1/2017

Open Access 01-12-2017 | Research article

Cytoreductive surgery and Hyperthermic intra-operative peritoneal chemotherapy with Cisplatin for gastric peritoneal Carcinomatosis Monocentric phase-2 nonrandomized prospective clinical trial

Authors: Baki Topal, Karel Demey, Halit Topal, Joris Jaekers, Eric Van Cutsem, Vincent Vandecaveye, Xavier Sagaert, Hans Prenen

Published in: BMC Cancer | Issue 1/2017

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Abstract

Background

Cytoreductive surgery (CRS) plus hyperthermic intra-operative peritoneal chemotherapy (HIPC) for gastric peritoneal carcinomatosis (PC) is controversial, and selection criteria for this treatment modality are lacking.

Methods

Thirty-two patients (F/M ratio 12/20; median (range) age 58 (32-75) years) underwent CRS + HIPC with cisplatin for PC from gastric adenocarcinoma in 2010-2014. This monocentric phase-2 nonrandomized prospective study with a power of 90% aimed to improve the 1-year overall survival (OS) rate with 40% (historical reference of 52% to 72%). Median PCI score was 8 (range 1-20), number of regions involved was 6 (range 1-11). The impact of 16 prognostic factors on survival was evaluated using univariable and multivariable Cox regression models. Follow-up was complete in all patients, and closed 2 years after patient inclusion.

Results

All patients had complete cytoreduction (CCR-0) and histopathological R0 resection. PCI </= 12 without PC on any small bowel region with 4 or more non-small bowel regions resulted in a median OS time of 24.7 months (15.6–29.4), and 1, 2, 5-year OS rates of 90%, 55%, 5.6%, respectively. Independent predictors of OS were PC on the small bowel combined with PC on 4 or more non-small bowel regions (p = 0.0004), number of regions involved (p = 0.0029), and overall PCI score (p = 0.0104).

Conclusions

CRS + HIPC with cisplatin to treat gastric PC, providing complete cytoreduction and R0 resection, should be restricted to patients with PCI of 12 or less. Patients having PC on any small bowel region with 4 or more non-small bowel regions should be refused for CRS + HIPC.

Trial registration number

Registration number: NCT01116791. Registration date: May 5, 2010.
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Metadata
Title
Cytoreductive surgery and Hyperthermic intra-operative peritoneal chemotherapy with Cisplatin for gastric peritoneal Carcinomatosis Monocentric phase-2 nonrandomized prospective clinical trial
Authors
Baki Topal
Karel Demey
Halit Topal
Joris Jaekers
Eric Van Cutsem
Vincent Vandecaveye
Xavier Sagaert
Hans Prenen
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2017
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-017-3730-6

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