Preventive Use of PIPAC in Locally Advanced Gastric Cancer.

NCT06784765 | Recruiting DMC

• 2 other identifiers: KAZNEOPACBR24992950
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related mortality. In patients with locally advanced gastric cancer, multimodal treatment strategies, including perioperative chemotherapy, have significantly improved survival rates. Despite these advances, peritoneal carcinomatosis (PC) remains a serious problem, occurring in 60% of cases after radical surgery. PC is associated with poor prognosis and limited treatment options. Intra-abdominal chemotherapy, particularly hyperthermic intraperitoneal chemoperfusion (HIPEC), has demonstrated advantages in the treatment of PC. However, a new technique, pressurized intraperitoneal aerosolized chemotherapy (PIPAC), is emerging as a promising alternative. PIPAC delivers chemotherapeutic agents directly to the peritoneal surface as an aerosol, allowing deeper penetration of drugs into tumor implants while minimizing toxicity and invasiveness. This study hypothesizes that the addition of PIPAC as a preoperative treatment for patients with locally advanced gastric cancer may reduce the incidence of peritoneal carcinomatosis compared to standard therapy. The primary objective of this study is to determine whether preoperative PIPAC reduces the incidence of peritoneal carcinomatosis in these patients.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; peritoneal carcinomatosis; gastrectomy; PIPAC; FLOT

Outcome Measures

Primary Outcomes (1)

• Incidence of peritoneal carcinomatosis

  Incidence of Peritoneal Carcinomatosis refers to the frequency or rate at which new cases of peritoneal carcinomatosis are diagnosed within a specific population over a defined period.

  12, 24 months after surgery

Secondary Outcomes (4)

• Overall survival

  1. 3, 5 years after surgery

• Disease-free survival

  3, 6, 9, 12, 18, 24 months after surgery

• Quality of life by EORTC QLQ-C30

  before surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery

• Frequency of adverse events

  through study completion, 30 days after surgery, 90 days after surgery

Study Arms (2)

PIPAC+FLOT

EXPERIMENTAL

◦ Preventive pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin (10 mg/m2) and doxorubicin (2.1 mg/m2) + perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 D2 lymphadenectomy.

Procedure: Intervention Group

FLOT

ACTIVE COMPARATOR

Retrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 D2 lymphadenectomy.

Procedure: Control Group

Interventions

Intervention Group PROCEDURE

Preventive pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin (10 mg/m2) and doxorubicin (2.1 mg/m2) + perioperative chemotherapy (FLOT regimen) +gastrectomy with D2 lymphadenectomy

Also known as: doxorubicin (2.1 mg/m2), cisplatin (10 mg/m2), perioperative chemotherapy (FLOT regimen), gastrectomy, D2 lymphadenectomy, Preventive pressurized intraperitoneal aerosol chemotherapy (PIPAC)

PIPAC+FLOT

Control Group PROCEDURE

Retrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 lymphadenectomy

Also known as: standard perioperative chemotherapy (FLOT regimen), gastrectomy, D2 lymphadenectomy

FLOT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Aged 18-70 years
• ECOG performance status 0-2
• Histologically confirmed adenocarcinoma of the stomach (T3-4N0-3M0)
• Negative peritoneal cytology from diagnostic laparoscopy
• No prior chemotherapy or radiotherapy

You may not qualify if:

• Presence of distant metastases
• Positive peritoneal cytology
• Previous cancer treatment (chemotherapy, radiotherapy, or surgery)
• Severe comorbid conditions contraindicating surgery or chemotherapy
• Pregnancy or lactation
• Known hypersensitivity to study drugs

Sponsors & Collaborators

• National Research Oncology and Transplantology Center, Kazakhstan: lead
• Ministry of Science and Higher Education of the Republic of Kazakhstan: collaborator

Study Sites (1)

National Research Oncology Centre

Astana, 010000, Kazakhstan

RECRUITING

Related Publications (6)

• Sgarbura O, Eveno C, Alyami M, Bakrin N, Guiral DC, Ceelen W, Delgadillo X, Dellinger T, Di Giorgio A, Kefleyesus A, Khomiakov V, Mortensen MB, Murphy J, Pocard M, Reymond M, Robella M, Rovers KP, So J, Somashekhar SP, Tempfer C, Van der Speeten K, Villeneuve L, Yong WP, Hubner M. Consensus statement for treatment protocols in pressurized intraperitoneal aerosol chemotherapy (PIPAC). Pleura Peritoneum. 2022 Mar 1;7(1):1-7. doi: 10.1515/pp-2022-0102. eCollection 2022 Mar 1.

  PMID: 35602919 BACKGROUND

• Coccolini F, Nardi M, Montori G, Ceresoli M, Celotti A, Cascinu S, Fugazzola P, Tomasoni M, Glehen O, Catena F, Yonemura Y, Ansaloni L. Neoadjuvant chemotherapy in advanced gastric and esophago-gastric cancer. Meta-analysis of randomized trials. Int J Surg. 2018 Mar;51:120-127. doi: 10.1016/j.ijsu.2018.01.008. Epub 2018 Feb 20.

  PMID: 29413875 BACKGROUND

• Al-Batran SE, Lorenzen S. Management of Locally Advanced Gastroesophageal Cancer: Still a Multidisciplinary Global Challenge? Hematol Oncol Clin North Am. 2017 Jun;31(3):441-452. doi: 10.1016/j.hoc.2017.01.004. Epub 2017 Mar 29.

  PMID: 28501086 BACKGROUND

• Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. doi: 10.1056/NEJMoa010187.

  PMID: 11547741 BACKGROUND

• Cotte E, Passot G, Gilly FN, Glehen O. Selection of patients and staging of peritoneal surface malignancies. World J Gastrointest Oncol. 2010 Jan 15;2(1):31-5. doi: 10.4251/wjgo.v2.i1.31.

  PMID: 21160814 BACKGROUND

• Kerimkulov A, Uskenbayev T, Sarina T, Mamlin M, Shalekenov S, Yessenbayeva G, Kainazarov T, Burkitbayev Z, Ussipbekov B, Kovalchuk D, Rakhmankulov A, Rakhmankulova A, Gaipov A. Efficacy of Preventive Pressurized Intraperitoneal Aerosol Chemotherapy in Patients With Locally Advanced Gastric Cancer: Protocol for a Prospective Controlled Trial. JMIR Res Protoc. 2025 Nov 11;14:e78053. doi: 10.2196/78053.

  PMID: 41218205 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Peritoneal Neoplasms

Interventions

Doxorubicin; Cisplatin; Gastrectomy; Control Groups

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Digestive System Surgical Procedures; Surgical Procedures, Operative; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Altay Kerimkulov, MD

CONTACT

+77014382825; altay.kerimkulov@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 20, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)