NCT04595929

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

Single-center Randomized Study Evaluating of Oncological Benifits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With Locally Advanced Gastric Cancer in Patients With Cyt-.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: St. Petersburg State Pavlov Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is interventional: patients over 18 years of age with an established diagnosis of stomach cancer (c)T3-4N0-3M0 CYT- will be randomized into 2 groups using the envelope method. The control group will receive only neoadjuvant chemotherapy + gastrectomy/ distal subtotal resection with D2 lymph node dissection, the active comparison group - neoadjuvant chemotherapy + gastrectomy with D2 lymph node dissection + PIPAC (Cisplatin (7.5 mg / m²) + Doxirubicin 1.5 mg / m2)). Will be assessed: overall survival, median survival, disease-free survival, quality of life of patients.

Conditions

• Peritoneal Carcinomatosis
• Gastric Cancer

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2020-02-10
• Primary completion: 2021-10-10
• Completion: 2029-01-10
• First posted: 2020-10-22
• Last updated: 2020-11-25

Locations

1 site across 1 country: Russia