106
Participants
Start Date
January 19, 2023
Primary Completion Date
January 19, 2026
Study Completion Date
January 19, 2026
Docetaxel
Docetaxel 50 mg/m2 intravenously on day 1
Oxaliplatin
Oxaliplatin 85 mg/m2 on Day 1
Calcium folinate
200 mg/m2 2-hour intravenous infusion on day 1
Fluorouracil
2600 mg/m2 x intravenous infusion 24-hours (infusion of the samee of the total dose of fluorouracil for 48 hours) on day 1.
Diagnostic laparoscopy
Access to the abdominal cavity by Hassen (3 trocars). Carboxyperitoneum - 12 mm of water column - stable pressure maintenance throughout the operation. Revision. Photo recording of 4 quadrants of the abdominal cavity from the paraumbilical port. The evaluation of the PCI index. The evaluation of other distant dissemination. Standard peritoneal lavage of 300 ml Sol. NaCl 0.9 % (37 ºС), with the exposure of 3-5 minutes (with Trendelenburg and Fowler position alternately) and the lavage aspiration, the transfer of the lavage for the cytological examination. Biopsy of perioneal lessions if needed.The operation is completed as standard with the extraction of laparoports and suturing of laparoport wounds.
dPIPAC ( The description of the standard diagnostic laparoscopy procedure and the session of PIPAC (dPIPAC)).
Diagnostic laparoscopy described earlier and PIPAC session. The drugs for PIPAC - Docetaxel 50 mg/ m2 diluted with saline sodium chloride to a total volume of 200 ml. The rate of administration is 30 ml per minute. The maximum pressure in the injector system is 250 PSI. After the spray stage, the exposure is 30 minutes while maintaining the declared intraperitoneal pressure. After the exposure stage, only gas is removed from the abdominal cavity. The operation is completed as standard with the extraction of laparoports and suturing of laparoport wounds.
RECRUITING
"Research Institute of Clinical Oncology Nizhny Novgorod Regional Clinical Oncological Dispensary", Nizhny Novgorod
Nizhny Novgorod Regional Clinical Oncology Center
OTHER_GOV