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Clinical Trial
. 2023 Oct 25;23(1):1032.
doi: 10.1186/s12885-023-11549-z.

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

Martynas Luksta #  1 , Augustinas Bausys #  2   3 , Klaudija Bickaite  4 , Rokas Rackauskas  4 , Marius Paskonis  4 , Raminta Luksaite-Lukste  5 , Anastasija Ranceva  6 , Rokas Stulpinas  7 , Birute Brasiuniene  8   9 , Edita Baltruskeviciene  8 , Nadezda Lachej  8 , Rasa Sabaliauskaite  10 , Rimantas Bausys  4   2 , Skaiste Tulyte  6   9 , Kestutis Strupas  4   3
Affiliations
Clinical Trial

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

Martynas Luksta et al. BMC Cancer. .

Abstract

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 4th 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.

Keywords: Gastric cancer; PIPAC; Peritoneal metastases.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Patients treatment (standard systemic chemotherapy and PIPAC) pathway
See this image and copyright information in PMC

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