protocolSection identificationModule nctId: NCT06313801, orgStudyIdInfo id: DPNCD-2309, briefTitle: Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-19, primaryCompletionDateStruct date: 2026-01-19, completionDateStruct date: 2026-01-19, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Nizhny Novgorod Regional Clinical Oncology Center, class: OTHER_GOV, descriptionModule briefSummary: 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., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the control group, after diagnostic laparoscopy, 6 courses of PCT FLOT are carried out, examination every 3 courses with the performance of control diagnostic laparoscopy after 6 courses of PCT. In the study group, after diagnostic laparoscopy, FLOT PCT courses (1st, 3rd, 5th courses), mFLOT (2nd, 4th, 6th courses) are conducted, examination every 3 courses with dPIPAC sessions with docetaxel (excluding it from systemic administration) on the 2nd, 4th, 6th courses of PCT. In group 2, the function of control laparoscopy is performed by revision at the dPIPAC session of the 6th course of PCT. In both groups, with complete regression of foci along the peritoneum and Cy- in peritoneal lavage - dynamic observation or cytoreductive surgery, with incomplete response - dynamic observation before progression, with progression - the 2nd line of CT or optimal palliative care options., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: Docetaxel, interventions name: Oxaliplatin, interventions name: Calcium folinate, interventions name: Fluorouracil, interventions name: Diagnostic laparoscopy, interventions name: dPIPAC ( The description of the standard diagnostic laparoscopy procedure and the session of PIPAC (dPIPAC))., outcomesModule primaryOutcomes measure: The progression-free survival., primaryOutcomes measure: Complications from polychemotherapy., secondaryOutcomes measure: The overall survival., secondaryOutcomes measure: The completeness of the planned therapy., secondaryOutcomes measure: Percentage of patient conversions to Су- and PCI- rate., secondaryOutcomes measure: Surgical complications of operated patients, secondaryOutcomes measure: Аssessment of the quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary", status: RECRUITING, city: Nizhny Novgorod, zip: 603126, country: Russian Federation, contacts name: Sergey Klimin, role: CONTACT, phone: +79875403280, email: kliminsergey7@gmail.com, geoPoint lat: 56.32867, lon: 44.00205, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-01-17, uploadDate: 2024-03-10T15:27, filename: Prot_SAP_000.pdf, size: 393857, hasResults: False