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HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)

NCT04447352 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-11-12

No results posted yet for this study

Summary

This is a multicenter, randomized, controlled, open-label study evaluating efficacy and safety of perioperative FLOT chemotherapy plus intraoperative HIPEC versus FLOT chemotherapy alone in patients with resectable localized and locally advanced diffuse and mixed type adenocarcinoma of the stomach and Type II/III GEJ.

Conditions

Interventions

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

DRUG

Cisplatin

intraoperative: 75mg/m² intraabdominal solution over 1 hour and 30 minutes

Sponsors & Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

    collaborator OTHER

  • Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Thorsten O Götze, MD · Lead Coordinating Investigator

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
2020-12-17
Primary Completion
2026-11-01
Completion
2027-05-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT04447352 on ClinicalTrials.gov