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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

342

Participants

Timeline

Start Date

June 3, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Gastroesophageal Junction Adenocarcinoma
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

Trial Locations (1)

68167

Unversity Hospital Mannheim, Mannheim

All Listed Sponsors
collaborator

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER

collaborator

Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

lead

Universitätsmedizin Mannheim

OTHER