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

STATUS

Recruiting
End date

Jan 10, 2029
participants needed

304
sponsor

St. Petersburg State Pavlov Medical University

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Updated on 27 January 2021

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gastrectomy

renal function

fluorouracil

doxorubicin

oxaliplatin

neutrophil count

leucovorin

docetaxel

laparoscopy

cancer chemotherapy

adenocarcinoma

adjuvant chemotherapy

immunostimulants

peritoneal carcinomatosis

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.

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 / m) + Doxirubicin 1.5 mg / m2)). Will be assessed: overall survival, median survival, disease-free survival, quality of life of patients.

Details

Condition	Abdominal Neoplasm, Abdominal Cancer, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, Gastropathy, Stomach Discomfort, Gastric Cancer, Gastric Cancer, Stomach Cancer, Stomach Discomfort, Peritoneal Carcinomatosis, Gastric Carcinoma, Abdominal Cancer, Stomach Cancer, Digestive System Neoplasms, gastric cancers
Treatment	docetaxel, Oxaliplatin, Leucovorin, 5-fluorouracil, Adjuvant chemotherapy, PIPAC, Staging Laparoscopy, Radical Surgery
Clinical Study Identifier	NCT04595929
Sponsor	St. Petersburg State Pavlov Medical University
Last Modified on	27 January 2021

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Histologically confirmed, medically operable, resectable stomach adenocarcinoma (cT3-4, any N category, M0)
	No preceding cytotoxic or targeted therapy
	No prior partial or complete tumor resection
	Female and male patient 18 and 75 years. Female patient with childbearing potential needs to have a negative pregnancy test within 7 days prior to study start. Males and females of reproductive potential must agree to practice highly effective contraceptive measures during the study. Male patients must also agree to refrain from father a child during treatment and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure
	highly effective (i.e. failure rate of <1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments)
	ECOG = 0-2
	Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the infiltration of any adjacent organs or structures by CT or MRI
	Laparoscopic exclusion of peritoneal carcinomatosis at initial staging, before start of FLOT chemotherapy
	Adequate hematological, hepatic and renal function parameters
	Leukocytes 3000/mm, platelets 100,000/mm, neutrophil count (ANC) 1000/L Serum
	creatinine 1.5 x upper limit of normal Bilirubin 1.5 x upper limit of normal
	AST and ALT 3.0 x upper limit of normal, alkaline phosphatase 6 x upper limit
	of normal For patients not receiving therapeutic anticoagulation: INR or aPTT
	5 x ULN; for patients receiving therapeutic anticoagulation: stable
	anticoagulant regimen
	Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
Exclusion Criteria
	Patient without neoadjuvant therapy or those who received a neoadjuvant therapy other than FLOT
	Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, or docetaxel
	Other known contraindications against, 5-FU, leucovorin, oxaliplatin, or docetaxel
	Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV
	Clinically significant valvular defect
	Criteria of primary unresectability, e.g
	Radiologically documented evidence of major blood vessel invasion or invasion
	of adjacent organs (T4b)
	Patients with involved retroperitoneal (e.g. para-aortal, paracaval or
	interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastases!)
	Other severe internal disease or acute infection
	Peripheral polyneuropathy NCI Grade II
	Patient has undergone major surgery within 28 days prior to enrollment except staging laparoscopy
	Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or ascites
	On-treatment participation in another interventional clinical study in the period 30 days prior to inclusion and during the study
	Patient pregnant or breast feeding, or planning to become pregnant
	Any other concurrent antineoplastic treatment including irradiation

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