NCT04595929View on ClinicalTrials.gov

Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-

NARecruitingINTERVENTIONAL
Enrollment

304

Participants

Timeline

Start Date

February 10, 2020

Primary Completion Date

October 10, 2021

Study Completion Date

January 10, 2029

Conditions
Peritoneal CarcinomatosisGastric Cancer
Interventions
PROCEDURE

Staging laparoscopy

All patients undergo staging laparoscopy and peritoneal lavage.

DRUG

5-Fluorouracil

Day 1 q2w: 2600 mg/m² IV over 24 hours

DRUG

Leucovorin

Day 1 q2w: 200 mg/m² IV over 30 minutes

DRUG

Oxaliplatin

Day 1 q2w: 85 mg/m² IV over 2 hours

DRUG

Docetaxel

Day 1 q2w: 50 mg/m² IV over 1 hour

PROCEDURE

Radical surgery

Radical gastrectomy with D2 - lymph node dissection.

PROCEDURE

PIPAC

Intraoperative Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin 7,5 mg/m², doxorubicin 1,5 mg/m².

DRUG

Adjuvant chemotherapy

Adjuvant chemotherapy according to indications.

Trial Locations (1)

197101

RECRUITING

First Pavlov State Medical University of St. Petersburg, Saint Petersburg

All Listed Sponsors
lead

St. Petersburg State Pavlov Medical University

OTHER