Actively Recruiting
Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-
Led by St. Petersburg State Pavlov Medical University · Updated on 2020-11-25
304
Participants Needed
1
Research Sites
465 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed, medically operable, resectable stomach adenocarcinoma (cT3-4, any N category, M0)
- No prior cytotoxic or targeted therapy
- No prior partial or complete tumor resection
- Male or female aged 18 to 75 years
- Female patients with childbearing potential must have a negative pregnancy test within 7 days before study start
- Males and females of reproductive potential must agree to use highly effective contraception during the study
- Male patients must agree to abstain from fathering a child and use a condom during treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- No distant metastases as confirmed by CT, MRI, bone scan, or other imaging
- No infiltration of adjacent organs or structures as confirmed by CT or MRI
- Laparoscopic exclusion of peritoneal carcinomatosis before starting chemotherapy
- Adequate blood counts and liver and kidney function
- Ability and willingness to provide written informed consent and comply with study procedures
You will not qualify if you...
- No neoadjuvant therapy or neoadjuvant therapy other than FLOT
- Known allergy or contraindication to 5-FU, leucovorin, oxaliplatin, or docetaxel
- Clinically significant active coronary heart disease, cardiomyopathy, or congestive heart failure (NYHA III-IV)
- Significant valvular heart defect
- Evidence of unresectability such as major blood vessel invasion or involvement of adjacent organs (T4b)
- Involvement of retroperitoneal or mesenteric lymph nodes (distant metastases)
- Severe internal disease or acute infection
- Peripheral polyneuropathy grade II or higher
- Major surgery within 28 days prior to enrollment (except staging laparoscopy)
- Liver cirrhosis Child-Pugh B or worse, or cirrhosis with history of encephalopathy or ascites
- Participation in another interventional study within 30 days prior and during this study
- Pregnancy, breastfeeding, or planning pregnancy
- Any other concurrent cancer treatment including radiation therapy
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Trial Site Locations
Total: 1 location
1
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, Russia, 197101
Actively Recruiting
Research Team
A
Alexander Zakharenko, PhD
CONTACT
M
Michael Belyaev, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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