RecruitingNot ApplicableNCT04595929

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-.


Sponsor

St. Petersburg State Pavlov Medical University

Enrollment

304 participants

Start Date

Feb 10, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a technique called PIPAC (pressurized intraperitoneal aerosol chemotherapy) — where chemotherapy is delivered as a fine mist directly into the abdominal cavity using a laparoscopic procedure — before standard stomach cancer surgery. The goal is to see if this approach reduces the chance of cancer spreading to the lining of the abdomen (peritoneal recurrence). **You may be eligible if...** - You have stomach (gastric) adenocarcinoma that can be surgically removed (resectable) and has grown into or through the stomach wall (T3-T4) - You have not had any prior chemotherapy or tumor removal surgery - You are between 18 and 75 years old - You are willing to use reliable contraception during the study **You may NOT be eligible if...** - You have already received chemotherapy or had prior stomach surgery - Cancer has already spread to distant organs - You are pregnant or breastfeeding - You are not a suitable candidate for surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStaging laparoscopy

All patients undergo staging laparoscopy and peritoneal lavage.

DRUG5-Fluorouracil

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

DRUGLeucovorin

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

DRUGOxaliplatin

Day 1 q2w: 85 mg/m² IV over 2 hours

DRUGDocetaxel

Day 1 q2w: 50 mg/m² IV over 1 hour

PROCEDURERadical surgery

Radical gastrectomy with D2 - lymph node dissection.

PROCEDUREPIPAC

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

DRUGAdjuvant chemotherapy

Adjuvant chemotherapy according to indications.


Locations(1)

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, Russia

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NCT04595929


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