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

• Status: Active, not recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Freiburg
• Collaborators: Clinical Trials Unit Freiburg; CTC laboratories at University of Hamburg and University of Freiburg; ESOPEC reference pathology at the University of Freiburg; Universitätsklinikum Leipzig, Universitäres Krebszentrum (UCCL)
• Treatments: Carboplatin; Docetaxel; Fluorouracil; Leucovorin; Oxaliplatin; Paclitaxel

Criteria

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 should have pulmonary function tests with FEV1 >65% of predicted)

• 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 (FEV1 <65% of predicted)

• Peripheral neuropathy Grade >1