The Single-center Randomized Study Comparison of Safety and Effectiveness of the First Line of Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions in Primary Gastric Cancer With Isolated Peritoneal Carcinomatosis.
After the initial diagnostic laparoscopy the Control group patients undergo 6 courses of polychemotherapy according to the FLOT scheme; the examination is carried out every 3 courses (after the 3rd and the 6th courses) with the control diagnostic laparoscopy after 6 courses of polychemotherapy. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered. After the initial diagnostic laparoscopy the Study group patients undergo courses of polychemotherapy according to the scheme FLOT (the 1st, the 3rd, the 5th courses) and mFLOT (the 2nd , the 4th, the 6th courses) in the amount of 6 (six, 3+3); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with dPIPAC sessions using docetaxel (thus excluding it from the system administration) in the 2nd , the 4th, the 6th courses of polychemotherapy. Control diagnostic laparoscopy is not performed in the group No 2, its function is performed by the revision at the PIPAC session of the 6th course of polychemotherapy, which corresponds to the time interval of the Control group. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered.
• Availability of signed informed voluntary consent of the patient
• Age ≥18 years and ≤75 years
• ECOG ≤1
• Histological verification of gastric cancer and esophageal-gastric junction Siewert III (adenocarcinoma, ring-cell carcinoma)
• Her2-neu negative tumor status
• The presence of a preserved informative block of the primary tumor in the histological archive of the NOCOD (performing a biopsy and/or providing archival material - with the consent of the patient)
• Verified gastric cancer (adenocarcinoma, ring-cell carcinoma) with the presence of M1 (with the only manifestation of M1 in the form of - Cy+ in initial peritoneal lavage and/or peritoneal dissemination PCI \<16)
• Peritoneal adhesion index PAI \<16
• Absence of active infectious, mental diseases, pronounced allergic conditions, as well as other concomitant pathology that may interfere with the implementation of the therapeutic and diagnostic measures provided for in the protocol
⁃ Adequate organ function (evaluation by laboratory parameters at screening - evaluation of hemoglobin, neutrophils, platelets, AST, ALT, total bilirubin, urea, creatinine)
⁃ Consent of men and women with preserved childbearing potential to use highly effective methods of contraception.