Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in multimodal therapy for patients with oligometastatic peritoneal gastric cancer: a randomized multicenter phase III trial PIPAC VEROne-Reference-Cited by-同舟云学术

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in multimodal therapy for patients with oligometastatic peritoneal gastric cancer: a randomized multicenter phase III trial PIPAC VEROne

Published:2022-06-07 Issue:3 Volume:7 Page:135-141
ISSN:2364-768X
Container-title:Pleura and Peritoneum
language:en
Short-container-title:

Author:

Casella Francesco¹,Bencivenga Maria¹,Rosati Riccardo²,Fumagalli Uberto Romario³,Marrelli Daniele⁴,Pacelli Fabio⁵,Macrì Antonio⁶,Donini Annibale⁷,Torroni Lorena⁸,Pavarana Michele⁹,De Manzoni Giovanni¹

Affiliation:

1. Department and of Surgical, General and Upper GI Surgery Division, Odontostomatologic, Maternal and Child Sciences , University of Verona , Verona , Italy

2. Department of Surgery , San Raffaele Hospital, San Raffaele Vita-salute University , Milan , Italy

3. Digestive Surgery , European Institute of Oncology , Milan , Italy

4. Department of Surgery , Siena University Hospital, University of Siena , Siena , Italy

5. Surgical Unit of Peritoneum and Retroperitoneum Surgery , Fondazione Policlinico Universitario A. Gemelli, IRCCS , Rome , Italy

6. Peritoneal Surface Malignancy and Soft Tissue Sarcoma Program , University of Messina , Messina , Italy

7. General and Emergency Surgery , Santa Maria Della Misericordia Hospital, University of Perugia , Perugia , Italy

8. Department of Diagnostic and Public Health, Unit of Epidemiology and Medical Statistics , University of Verona , Verona , Italy

9. Department of Oncology , University of Verona , Verona , Italy

Abstract

Abstract Objectives Peritoneal carcinomatosis is the most frequent site of metastases in patients with gastric cancer. Current standard treatment is palliative systemic chemotherapy with very poor prognosis. Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) resulted in long-term benefits in selected patients. Among patients with peritoneal carcinomatosis, a distinctive subset is oligometastatic disease which is characterized by low metastatic burden. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a recent technique of intraperitoneal chemotherapy used in combination with systemic chemotherapy with promising results. Methods PIPAC VER-One is a prospective, randomized, multicenter phase III clinical trial that aims to evaluate the effectiveness of the use of PIPAC in combination with systemic chemotherapy in patients with gastric cancer and synchronous positive peritoneal cytology and/or limited peritoneal metastases (peritoneal cancer index [PCI] ≤6). Patients will be randomized into two arms: arm A (control) treated with standard systemic chemotherapy and arm B (experimental) treated with a bidirectional scheme including PIPAC and systemic chemotherapy. Results Primary endpoint is the secondary resectability rate. Secondary endpoints are: overall survival (OS), pregression-free survival (PFS), disease-free survival (DFS), histological response assessed both on primary tumor and peritoneal lesions, quality of life (QoL), complication rate (CTCAE v5), and incremental cost-effectiveness ratios (ICER). Conclusions The role of PIPAC in multimodal treatment for oligometastatic gastric cancer will be investigated in this trial.

Publisher

Walter de Gruyter GmbH

Subject

Internal Medicine

Link

https://www.degruyter.com/document/doi/10.1515/pp-2022-0111/pdf

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