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

Phase 3

• Conditions: Esophageal Adenocarcinoma (UICC TNM7)Adenocarcinoma of the Esophagogastric Junction; C15; Malignant neoplasm of oesophagus

• Registration Number: DRKS00008008
• Lead Sponsor: niversity Hospital Schleswig-Holstein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-03
• Study Completion: 2023-11-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• 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 should 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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Overall survival; time frame: At end of trial- up to 3 years in follow up; Overall survival will be calculated as time from start of study treatment to death due to any cause.<br>

Secondary Outcome Measures

Name	Time	Method
- Progression free survival time (PFS); time frame: From randomisation up to 3 years in follow up; PFS will be calculated as the time interval from randomisation to the first event of locoregional failure, metastatic progression or death.<br>- Site of failure: local, regional or distant Failure; time frame: From time of surgery up to 3 years in follow up<br>- Recurrence free survival time; time frame: From time of surgery up to 3 years in follow up; RFS will be calculated in resected patients who achieved an R0 or R1 resection as the time interval from surgery to the date of first recurrence (local, regional or distant) or death, whatever comes first.<br>- Postsurgical Quality of Life; time frame: From randomization up to 3 years in follow up<br>- Postoperative complications; time frame: From time of surgery up to 90 days postoperatively<br>- Non-surgical site complications; time frame: From time of surgery up to 90 days postoperatively