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.
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.
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.
Parallel
Staging laparoscopy
Procedure/SurgeryAll patients undergo staging laparoscopy and peritoneal lavage.
5-Fluorouracil
DrugDay 1 q2w: 2600 mg/m² IV over 24 hours
Leucovorin
DrugDay 1 q2w: 200 mg/m² IV over 30 minutes
Oxaliplatin
DrugDay 1 q2w: 85 mg/m² IV over 2 hours
Docetaxel
DrugDay 1 q2w: 50 mg/m² IV over 1 hour
Radical surgery
Procedure/SurgeryRadical gastrectomy with D2 - lymph node dissection.
PIPAC
Procedure/SurgeryIntraoperative Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin 7,5 mg/m², doxorubicin 1,5 mg/m².
Adjuvant chemotherapy
DrugAdjuvant chemotherapy according to indications.
Comparison of Overall survival (OS) in both arms
Overall survival (OS) where OS is defined as the time from randomization to death from any cause.
Comparison of Overall survival rates at 3 and 5 years in both arms
Overall survival rates at 3 \& 5 years defined as the percentage patients known to be alive after 3 and 5 years referring to the total number of patients randomized into the respective treatment arm
Comparison of progression-/disease-free survival (PFS/DFS) between arms
PFS/DFS is defined as the time from randomization to disease progression or relapse after surgery or death from any cause.
Comparison of peritoneal relapse rate in both arms
Peritoneal relapse rate defined as the percentage of patients with peritoneal relapse referring to the total number of patients randomized into the respective treatment arm
PFS/DFS rates at 2, 3 & 5 years
PFS/DFS rates at 2, 3 \& 5 years defined as the percentage of patients without disease progression or relapse after surgery or death from any cause after 2, 3 and 5 years referring to the total number of patients randomized into the respective treatment arm
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