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Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study

BACKGROUND: Gastric cancer (GC) remains among the most common and most lethal cancers worldwide. Peritoneum is the most common site for distant dissemination. Standard treatment for GC peritoneal metastases (PM) is a systemic therapy, but treatment outcomes remain very poor, with median overall surv...

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Autores principales: Luksta, Martynas, Bausys, Augustinas, Bickaite, Klaudija, Rackauskas, Rokas, Paskonis, Marius, Luksaite-Lukste, Raminta, Ranceva, Anastasija, Stulpinas, Rokas, Brasiuniene, Birute, Baltruskeviciene, Edita, Lachej, Nadezda, Sabaliauskaite, Rasa, Bausys, Rimantas, Tulyte, Skaiste, Strupas, Kestutis
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10599063/
https://www.ncbi.nlm.nih.gov/pubmed/37875869
http://dx.doi.org/10.1186/s12885-023-11549-z
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author Luksta, Martynas
Bausys, Augustinas
Bickaite, Klaudija
Rackauskas, Rokas
Paskonis, Marius
Luksaite-Lukste, Raminta
Ranceva, Anastasija
Stulpinas, Rokas
Brasiuniene, Birute
Baltruskeviciene, Edita
Lachej, Nadezda
Sabaliauskaite, Rasa
Bausys, Rimantas
Tulyte, Skaiste
Strupas, Kestutis
author_facet Luksta, Martynas
Bausys, Augustinas
Bickaite, Klaudija
Rackauskas, Rokas
Paskonis, Marius
Luksaite-Lukste, Raminta
Ranceva, Anastasija
Stulpinas, Rokas
Brasiuniene, Birute
Baltruskeviciene, Edita
Lachej, Nadezda
Sabaliauskaite, Rasa
Bausys, Rimantas
Tulyte, Skaiste
Strupas, Kestutis
author_sort Luksta, Martynas
collection PubMed
description BACKGROUND: Gastric cancer (GC) remains among the most common and most lethal cancers worldwide. Peritoneum is the most common site for distant dissemination. Standard treatment for GC peritoneal metastases (PM) is a systemic therapy, but treatment outcomes remain very poor, with median overall survival ranging between 3-9 months. Thus, novel treatment methods are necessary. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is the most novel technique for intraperitoneal chemotherapy. Some preliminary data suggest PIPAC can achieve improved long-term outcomes in patients with GC PM, especially when used in combination with systemic chemotherapy. However, there is a lack of data from well-design prospective studies that would confirm the efficacy of PIPAC and systemic therapy combination for first-line treatment. METHODS: This study is an investigator-initiated single-arm, phase II trial to investigate the efficacy of PIPAC combined with systemic FOLFOX (5-fluorouracil, oxaliplatin, leucovorin) as a first-line treatment for GC PM. The study is conducted in 2 specialized GC treatment centers in Lithuania. It enrolls GC patients with histologically confirmed PM without prior treatment. The treatment protocol consists of PIPAC with cisplatin (10.5 mg/m2 body surface in 150 mL NaCl 0.9%) and doxorubicin (2.1 mg/m2 in 50 mL NaCl 0.9%) followed by 2 cycles of FOLFOX every 6–7 weeks. In total 3 PIPACs and 6 cycles of FOLFOX will be utilized. The primary outcome of the study is the objective response rate (ORR) according to RECIST v. 1.1 criteria (Eisenhauer et al., Eur J Cancer 45:228–47) in a CT scan performed 7 days after the 4(th) cycle of FOLFOX. Secondary outcomes include ORR after all experimental treatment, PIPAC characteristics, postoperative morbidity, histological and biochemical response, ascites volume, quality of life, overall survival, and toxicity. DISCUSSION: This study aims to assess PIPAC and FOLFOX combination efficacy for previously untreated GC patients with PM. TRIAL REGISTRATION: NCT05644249. Registered on December 9, 2022.
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spelling pubmed-105990632023-10-26 Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study Luksta, Martynas Bausys, Augustinas Bickaite, Klaudija Rackauskas, Rokas Paskonis, Marius Luksaite-Lukste, Raminta Ranceva, Anastasija Stulpinas, Rokas Brasiuniene, Birute Baltruskeviciene, Edita Lachej, Nadezda Sabaliauskaite, Rasa Bausys, Rimantas Tulyte, Skaiste Strupas, Kestutis BMC Cancer Study Protocol BACKGROUND: Gastric cancer (GC) remains among the most common and most lethal cancers worldwide. Peritoneum is the most common site for distant dissemination. Standard treatment for GC peritoneal metastases (PM) is a systemic therapy, but treatment outcomes remain very poor, with median overall survival ranging between 3-9 months. Thus, novel treatment methods are necessary. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is the most novel technique for intraperitoneal chemotherapy. Some preliminary data suggest PIPAC can achieve improved long-term outcomes in patients with GC PM, especially when used in combination with systemic chemotherapy. However, there is a lack of data from well-design prospective studies that would confirm the efficacy of PIPAC and systemic therapy combination for first-line treatment. METHODS: This study is an investigator-initiated single-arm, phase II trial to investigate the efficacy of PIPAC combined with systemic FOLFOX (5-fluorouracil, oxaliplatin, leucovorin) as a first-line treatment for GC PM. The study is conducted in 2 specialized GC treatment centers in Lithuania. It enrolls GC patients with histologically confirmed PM without prior treatment. The treatment protocol consists of PIPAC with cisplatin (10.5 mg/m2 body surface in 150 mL NaCl 0.9%) and doxorubicin (2.1 mg/m2 in 50 mL NaCl 0.9%) followed by 2 cycles of FOLFOX every 6–7 weeks. In total 3 PIPACs and 6 cycles of FOLFOX will be utilized. The primary outcome of the study is the objective response rate (ORR) according to RECIST v. 1.1 criteria (Eisenhauer et al., Eur J Cancer 45:228–47) in a CT scan performed 7 days after the 4(th) cycle of FOLFOX. Secondary outcomes include ORR after all experimental treatment, PIPAC characteristics, postoperative morbidity, histological and biochemical response, ascites volume, quality of life, overall survival, and toxicity. DISCUSSION: This study aims to assess PIPAC and FOLFOX combination efficacy for previously untreated GC patients with PM. TRIAL REGISTRATION: NCT05644249. Registered on December 9, 2022. BioMed Central 2023-10-25 /pmc/articles/PMC10599063/ /pubmed/37875869 http://dx.doi.org/10.1186/s12885-023-11549-z Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Luksta, Martynas
Bausys, Augustinas
Bickaite, Klaudija
Rackauskas, Rokas
Paskonis, Marius
Luksaite-Lukste, Raminta
Ranceva, Anastasija
Stulpinas, Rokas
Brasiuniene, Birute
Baltruskeviciene, Edita
Lachej, Nadezda
Sabaliauskaite, Rasa
Bausys, Rimantas
Tulyte, Skaiste
Strupas, Kestutis
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study
title Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study
title_full Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study
title_fullStr Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study
title_full_unstemmed Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study
title_short Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study
title_sort pressurized intraperitoneal aerosol chemotherapy (pipac) with cisplatin and doxorubicin in combination with folfox chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase ii study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10599063/
https://www.ncbi.nlm.nih.gov/pubmed/37875869
http://dx.doi.org/10.1186/s12885-023-11549-z
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