ESOPEC

Perioperative Chemotherapy (FLOT Protocol) compared to neoadjuvant chemoradiation (CROSS Protocol) in patients with adenocarcinoma of the Esophagus (ESOPEC) 

Study design: Prospective open, randomised, controlled multicentre interdisciplinary trial.

Indication: Histologically proven adenocarcinoma of the esophagus according to the Union internationale contre le cancer (UICC) TNM7 definition. Both tumors of the esophagus and tumors of which the epicentre is within 5 cm of the esophagogastric junction and also extend into the esophagus can be included into the trial in case of adenocarcinomatous histology.

Primary endpoint: Overall survival time

Secondary endpoint:

- Progression free survival time
- Recurrence free survival time
- Site of tumor recurrence
- Postoperative pathological stage
- Quality of life (EORTC QLQ-C30, OES18, CIPN20)
- Hospitalisation time
- Postoperative complications
- Non-surgical site complications
- Adverse Events 

Inclusion criteria:
-
Histologically verified adenocarcinoma of the esophagus according to the UICC definition (TNM7)
- Pre-treatment stage cT1N+, M0 or cT2-4a, N0/+, M0
- Age ≥18 years
- No prior abdominal or thoracic radiotherapy
- ECOG Performance status 0-2
- Adequate cardiac function ( Patients with a cardiac history (e.g. myocardial infarction, heart failure, coronary artery disease) should have a cardiology review)
- Adequate bone marrow function (WBC>3x10^9/l; Hb>9g/dl; platelets >100x10^9/l)
- Adequate respiratory function. Symptomatic Patients shold have pulmonary function tests with FEV1>1,5l )
- Adequate renal function (GFR >60ml/min)
- Adequate liver function (serum bilirubin <1.5x Upper level of Normal (ULN); AST <2.5x ULN and ALT <3x ULN (ULN as per institutional standard)
- written informed consent

Exclusion criteria:
-
Tumors of squamous or other non-adenocarcinoma histology
- Patients with advanced inoperable or metastatic esophageal adenocarcinoma
- Stage cT1N0 and cT4b
- Gastric carcinoma
- Prior chemotherapy for cancer
- Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months)
- Clinical significant lung disease (FEV 1<1,5l)
- Peripheral neuropathy Grade >1

Trial objectives:

To investigate differences in outcome of patients treated with perioperative (neoadjuvant plus adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation (CROSS) plus surgical resection. The primary hypothesis is that perioperative chemotherapy plus surgery prolongs survival compared to neoadjuvant chemoradiation plus surgery in patients with adenocarcinoma of the esophagus.

Status: active

Start: 11.05.2017

EudraCT No.: 2015-001683-20

Zentrum im UCT Universitätsklinikum Frankfurt

Prüfer: Dr. med. Detlef Imhoff

Stellvertretender Prüfer: Dr. med. Christian Keller
Studiensekretariat:
Atefeh Nateghian

Margarita Diaz

Universitätsklinikum Frankfurt/Main

Zentrum für Radiologie und Strahlentherapie

Theodor-Stern Kai 7

60590 Frankfurt am Main

Tel: +49 (0)69 6301-4655/ 3742

E-Mail: studien-strahlen@kgu.de

 

Ansprechpartner Leiter der klinischen Prüfung

Prof. Dr. med. Jens Höppner

Medical Center- Universität Freiburg

Klinik für Allgemein- und Viszeralchirurgie
Hugstetter Str. 55
79106 Freiburg