Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions

PHASE2RecruitingINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

January 19, 2023

Primary Completion Date

January 19, 2026

Study Completion Date

January 19, 2026

Conditions
Gastric Cancer
Interventions
DRUG

Docetaxel

Docetaxel 50 mg/m2 intravenously on day 1

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m2 on Day 1

DRUG

Calcium folinate

200 mg/m2 2-hour intravenous infusion on day 1

DRUG

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.

PROCEDURE

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.

COMBINATION_PRODUCT

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.

Trial Locations (1)

603126

RECRUITING

"Research Institute of Clinical Oncology Nizhny Novgorod Regional Clinical Oncological Dispensary", Nizhny Novgorod

All Listed Sponsors
lead

Nizhny Novgorod Regional Clinical Oncology Center

OTHER_GOV

NCT06313801 - Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions | Biotech Hunter | Biotech Hunter