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Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence

NCT04597294 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-03-06

No results posted yet for this study

Summary

The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. The impact of treatment on peritoneal recurrence and survival over 6 months, 1, 3 and 5 years will be assessed.

Conditions

Interventions

COMBINATION_PRODUCT

FLOT + HIPEC + Surgery

HIPEC with irinotecan after 4 doses of preoperative FLOT chemotherapy

COMBINATION_PRODUCT

FLOT + Surgery

Perioperative FLOT chemotherapy (4 doses before and 4 doses after gastrectomy) and surgery

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Piotr Richter, Professor · Jagiellonian University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2026-01-31
Completion
2026-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597294 on ClinicalTrials.gov