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ACTIVE NOT RECRUITING
NCT04375605
PHASE3

Neoadjuvant RCT Versus CT for Patients With Locally Advanced, Potentially Resectable Adenocarcinoma of the GEJ

Sponsor: Universitätsmedizin Mannheim

View on ClinicalTrials.gov

Summary

This is a multicenter, prospective, randomized, stratified, controlled, open-label study comparing neoadjuvant radiochemotherapy with FLOT versus FLOT chemotherapy alone für patients with locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction (GEJ)

Official title: RACE-trial: Neoadjuvant Radiochemotherapy Versus Chemotherapy for Patients With Locally Advanced, Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) A Randomized Phase III Joint Study of the AIO, ARO and DGAV

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

342

Start Date

2020-06-03

Completion Date

2025-12

Last Updated

2025-01-07

Healthy Volunteers

No

Interventions

DRUG

5-Fluorouracil

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

DRUG

Calcium folinate

Day 1 q2w: 200 mg/m² IV over 2 hours

DRUG

Oxaliplatin

Day 1 q2w: 85 mg/m² IV over 2 hours

DRUG

Docetaxel

Day 1 q2w: 50 mg/m² IV over 2 hours

RADIATION

Radiation

25 fractions (5 each week over 5 weeks) each 1,8 Gy to a total of 45 Gy

DRUG

Oxaliplatin during radiotherapy

Day 1, 8, 15, 22, 29: 45 mg/m² IV over 2 hours

DRUG

5-Fluorouracil during radiotherapy

day 1 - 33: 225 mg/m²/day IV continuously

Locations (1)

Unversity Hospital Mannheim

Mannheim, Germany