Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the Esophagus - ESOPEC

Phase 1

• Conditions: 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.; MedDRA version: 21.1Level: LLTClassification code 10026180Term: Malignant neoplasm of oesophagusSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001683-20-DE
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein, Campus Lübeck

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-03
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 438

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 test 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)
-given informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Tumors of squamous histology
-Patients with advanced inoperable or metastatic esophageal adenocarcinoma
-Esophageal adenocarcinoma cT1N0 and cT4b
-Gastric carcinoma
-Prior chemotherapy for gastrointestinal cancer,
-Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 month)
-Clinically-significant lung disease (FEV1 <65% of predicted
-Peripheral neuropathy Grade >1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified