Revista ABCd (São Paulo). 26 jul, 2023

INTRAPERITONEAL CHEMOTHERAPY FOR GASTRIC CANCER WITH PERITONEAL CARCINOMATOSIS: STUDY PROTOCOL OF A PHASE II TRIAL

Marcus Fernando Kodama Pertille Ramos
Marina Alessandra Pereira
Amir Zeide Charruf
Carolina Ribeiro Victor
João Vitor Antunes Marques Gregorio
Luciana Bastos Valente Alban
Camila Motta Venchiarutti Moniz
Bruno Zilberstein
Evandro Sobroza de Mello
Paulo Marcelo Gehm Hoff
Ulysses Ribeiro Junior
Andre Roncon Dias
DOI: https://doi.org/10.1590/0102-672020230026e1744

BACKGROUND:

Peritoneal carcinomatosis in gastric cancer is considered a fatal disease, without expectation of definitive cure. As systemic chemotherapy is not sufficient to contain the disease, a multimodal approach associating intraperitoneal chemotherapy with surgery may represent an alternative for these cases.

AIMS:

The aim of this study was to investigate the role of intraperitoneal chemotherapy in stage IV gastric cancer patients with peritoneal metastasis.

METHODS:

This study is a single institutional single-arm prospective clinical trial phase II (NCT05541146). Patients with the following inclusion criteria undergo implantation of a peritoneal catheter for intraperitoneal chemotherapy: Stage IV gastric adenocarcinoma; age 18–75 years; Peritoneal carcinomatosis with peritoneal cancer index<12; Eastern Cooperative Oncology Group 0/1; good clinical status; and lab exams within normal limits. The study protocol consists of four cycles of intraperitoneal chemotherapy with paclitaxel associated with systemic chemotherapy. After treatment, patients with peritoneal response assessed by staging laparoscopy undergo conversion gastrectomy.

RESULTS:

The primary outcome is the rate of complete peritoneal response. Progression-free and overall survivals are other outcomes evaluated. The study started in July 2022, and patients will be screened for inclusion until 30 are enrolled.

CONCLUSIONS:

Therapies for advanced gastric cancer patients have been evaluated in clinical trials but without success in patients with peritoneal metastasis. The treatment proposed in this trial can be promising, with easy catheter implantation and ambulatory intraperitoneal chemotherapy regime. Verifying the efficacy and safety of paclitaxel with systemic chemotherapy is an important progress that this study intends to investigate.


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ABCD – BRAZILIAN ARCHIVES OF DIGESTIVE SURGERY is a periodic with a single annual volume in continuous publication, official organ of the Brazilian College of Digestive Surgery - CBCD. Technical manager: Dr. Francisco Tustumi | CRM: 157311 | RQE: 77151 - Cirurgia do Aparelho Digestivo

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