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

NCT04375605 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2025-01-07

No results posted yet for this study

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)

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

Sponsors & Collaborators

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    collaborator OTHER

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

    collaborator OTHER

  • Universitätsmedizin Mannheim

    lead OTHER

Principal Investigators

  • Ralf-Dieter Hofheinz, Prof. Dr. · Universitätsmedizin Mannheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-03
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Germany

Study Locations

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Entities

Drugs

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 NCT04375605 on ClinicalTrials.gov