NCT04595929: GASPACCO

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

Recruiting now NA Last updated 25 November 2020

What this trial tests

NA trial testing Staging laparoscopy in Peritoneal Carcinomatosis in 304 participants. Currently enrolling.

Timeline

10 February 2020

Primary endpoint
10 October 2021

10 January 2029

Quick facts

Lead sponsor	St. Petersburg State Pavlov Medical University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	304
Start date	10 February 2020
Primary completion	10 October 2021
Estimated completion	10 January 2029
Sites	1 location across Russia

Drugs / interventions tested

• Staging laparoscopy
• 5-Fluorouracil
• Leucovorin (leucovorin) — full drug profile →
• Oxaliplatin (Oxaliplatin) — full drug profile →
• Docetaxel (Docetaxel) — full drug profile →
• Radical surgery
• PIPAC — full drug profile →
• Adjuvant chemotherapy — full drug profile →

Conditions studied

• Peritoneal Carcinomatosis — all drugs for Peritoneal Carcinomatosis →
• Gastric Cancer — all drugs for Gastric Cancer →

Sponsor

St. Petersburg State Pavlov Medical University

Who can join

Adults 18 to 65, any sex, with Peritoneal Carcinomatosis or Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. PIPAC for Gastrointestinal Malignancies.
   Daniel SK, Sun BJ, Lee B. · · 2023 · cited 15× · PMID 37959264 · DOI 10.3390/jcm12216799
2. Is PIPAC a Treatment Option in Upper and Lower Gastrointestinal Cancer with Peritoneal Metastasis?
   Guel-Klein S, Alberto Vilchez ME, Ceelen W, Rau B, et al · · 2022 · cited 3× · PMID 35614892 · DOI 10.1159/000523901