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

Summary

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.

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.

Sponsors & Collaborators

• Nizhny Novgorod Regional Clinical Oncology Center

  lead OTHER_GOV

Principal Investigators

• Sergey Gamayunov, DMS · Chief oncology specialist in the region

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-19

Primary Completion

2026-07-01

Completion

2027-09-01

Countries

• Russia

Study Locations