Perioperative Chemotherapy Compared To Neoadjuvant Chemoradiation in Patients With Adenocarcinoma of the Esophagus

Summary

The trial is designed to investigate differences in outcome of patients with esophageal adenocarcinoma and junctional adenocarcinoma treated with perioperative (neoadjuvant + adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation (CROSS) plus surgical resection.

Conditions

• Esophageal Adenocarcinoma (UICC TNM7)
• Adenocarcinoma of the Esophagogastric Junction

Interventions

DRUG

5-Fluorouracil

2600 mg/m² (24 hours), d1 every two weeks;

DRUG

Leucovorin

200 mg/m² in 250 ml NaCl 0.9%, d1 every two weeks;

DRUG

Oxaliplatin

85 mg/m² in 500 ml G5% over 2h, d1 every two weeks;

DRUG

Docetaxel

50mg/m2 in 250 ml NaCl 0.9% over 1h, d1 every two weeks;

DRUG

Carboplatin

Dose-dependant: 2mg/ml/min AUC in 500ml Glucose 5%, day 1, 8, 15, 22 and day 29.

DRUG

Paclitaxel

50mg/m2 in 500ml NaCl 0.9% over 1 h, day 1, 8, 15, 22 and day 29;

RADIATION

Neoadjuvant radiation

41.4Gy given in 23 fractions of 1.8Gy on days 1-5, days 8-12, days 15-19, days 22-26 and days 29-31.

Sponsors & Collaborators

• Clinical Trials Unit Freiburg

  collaborator OTHER

• University of Freiburg

  collaborator OTHER

• University of Leipzig

  collaborator OTHER

• University of Luebeck

  collaborator OTHER

• University of Hamburg-Eppendorf

  collaborator OTHER

• University Hospital Schleswig-Holstein

  lead OTHER

Principal Investigators

• Jens Hoeppner, Professor · University Medical Center Schleswig-Holstein, Campus Lübeck

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2024-05-01

Completion

2024-12-31

Countries

• Germany

Study Locations