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.
According to the given evidence a survival benefit of perioperative chemotherapy (periCTX) over Neoadjuvant chemoradiation (neoCRT) for patients with Esophageal adenocarcinomas (EAC) has not been proven in any randomized controlled trials (RCT). Data supporting the value of periCTX have all been obtained in studies including mixed patient cohorts with EAC and gastric adenocarcinoma (GAC). Due to relevant differences of histologic subtype distribution, response to periCTX and survival rates between EAC and GAC there is a clear need to obtain evidence concerning the value of periCTX for EAC. As nowadays periCTX is extensively and successfully applied in clinical practice in patients with EAC there is an obvious need to obtain evidence from a multicentre RCT. Moreover a confirmation of the superior survival rates of the recent RCT on neoCRT should be obtained in a RCT conducted exclusively on EAC. Therefore, this prospective RCT with the primary objective of longterm patient survival comparing periCTX and neoCRT was designed. Translational Projects: Project 1+2: Circulating Tumor Cells as Biomarker in EAC CTC laboratories at University of Hamburg and University of Freiburg Project 3: Prognostic and predictive biomarkers in EAC University of Leipzig, UCCL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
438
2600 mg/m² (24 hours), d1 every two weeks;
200 mg/m² in 250 ml NaCl 0.9%, d1 every two weeks;
85 mg/m² in 500 ml G5% over 2h, d1 every two weeks;
Overall survival
Overall survival will be calculated as time from start of study treatment to death due to any cause.
Time frame: At end of trial- up to 3 years in follow up
Progression free survival time (PFS)
PFS will be calculated as the time interval from randomisation to the first event of locoregional failure, metastatic progression or death.
Time frame: From randomisation up to 3 years in follow up
Site of failure: local, regional or distant Failure
Time frame: From time of surgery up to 3 years in follow up
Recurrence free survival time
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.
Time frame: From time of surgery up to 3 years in follow up
Postsurgical Quality of Life
Time frame: From randomization up to 3 years in follow up
Postoperative complications
Time frame: From time of surgery up to 90 days postoperatively
Non-surgical site complications
Time frame: From time of surgery up to 90 days postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
50mg/m2 in 250 ml NaCl 0.9% over 1h, d1 every two weeks;
Dose-dependant: 2mg/ml/min AUC in 500ml Glucose 5%, day 1, 8, 15, 22 and day 29.
50mg/m2 in 500ml NaCl 0.9% over 1 h, day 1, 8, 15, 22 and day 29;
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.
Uniklinik RWTH Aachen
Aachen, Germany
Charité Berlin - Campus Benjamin Franklin (CBF)
Berlin, Germany
Charité Berlin Campus Virchow-Klinikum (CVK)
Berlin, Germany
Uniklinik Köln
Cologne, Germany
Klinikum Dortmund gGmbH
Dortmund, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
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