Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-

Summary

Stomach cancer is recognized as the third leading cause of death of cancer patients worldwide. Despite the radical treatment carried out, the progression of gastric cancer occurs in 30-40% of patients. The most common type of tumor progression of this localization is peritoneal carcinomatosis. When peritoneal carcinomatosis occurs, the median survival of patients does not exceed 3 months, the overall survival is no more than 6 months. Unfortunately, when peritoneal carcinomatosis occurs, palliative chemotherapy remains the only treatment option. The modern strategy for the prevention and treatment of peritoneal carcinomatosis is based on the concept of regional chemotherapy. The main methods of regional chemotherapy are hyperthermic intraperitoneal chemotherapy (HIPEC) and Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC). PIPAC is a new technology for delivering chemotherapy drugs to tumor nodes on the surface of the peritoneum and allows the cytostatic to be evenly distributed over the abdominal cavity, increasing the depth of its penetration into tumor nodes due to the properties of aerosol and gradients of intra-abdominal and interstitial pressure. The method has a number of advantages over the HIPEC method: a large penetration depth of drugs, low trauma, the possibility of repeated use. We offer PIPAC for patients with locally advanced gastric cancer and a high risk of developing peritoneal carcinomatosis in an adjuvant mode in addition to standard treatment to prevent the development of carcinomatosis.

Conditions

• Peritoneal Carcinomatosis
• Gastric Cancer

Interventions

DRUG

Oxaliplatin

Day 1 q2w: 85 mg/m² IV over 2 hours

DRUG

Docetaxel

Day 1 q2w: 50 mg/m² IV over 1 hour

PROCEDURE

Radical surgery

Radical gastrectomy with D2 - lymph node dissection.

PROCEDURE

PIPAC

Intraoperative Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin 7,5 mg/m², doxorubicin 1,5 mg/m².

DRUG

Adjuvant chemotherapy

Adjuvant chemotherapy according to indications.

PROCEDURE

Staging laparoscopy

All patients undergo staging laparoscopy and peritoneal lavage.

DRUG

5-Fluorouracil

Day 1 q2w: 2600 mg/m² IV over 24 hours

DRUG

Leucovorin

Day 1 q2w: 200 mg/m² IV over 30 minutes

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University

  lead OTHER

Principal Investigators

• Alexander Zakharenko, PhD · First Pavlov State Medical University of St. Petersburg

• Ilya Vervekin · First Pavlov State Medical University of St. Petersburg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-10

Primary Completion

2021-10-10

Completion

2029-01-10

Countries

• Russia

Study Locations