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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001683-20 | EudraCT Number | ||
| DRKS00008008 | Registry Identifier | DRKS |
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| Name | Class |
|---|---|
| Clinical Trials Unit Freiburg | OTHER |
| University of Freiburg | OTHER |
| University of Leipzig | OTHER |
| University of Luebeck |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perioperative Chemotherapy (FLOT): | Experimental | The FLOT Arm consists of the FLOT protocol, which consists of 5-Fluorouracil, Leucovorin, Oxaliplatin and Docetaxel. Repetition every 2 weeks (d15, q2w). Four neoadjuvant cycles (8 weeks) prior to surgery and four adjuvant cycles (8 weeks) postoperatively are given. Surgery is carried out by transthoracic subtotal esophagectomy or by transabdominal distal esophageal resection plus gastrectomy depending on tumor localization. |
|
| Neoadjuvant Chemoradiation (CROSS): | Active Comparator | The CROSS Arm consists of the CROSS protocol, which consists of neoadjuvant radiation therapy (41.4Gy / 23fractions) and concurrent chemotherapy with Carboplatin and Paclitaxel (5 weeks) prior to surgery. Surgery is carried out by transthoracic subtotal esophagectomy or by transabdominal distal esophageal resection plus gastrectomy depending on tumor localization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Fluorouracil | Drug | 2600 mg/m² (24 hours), d1 every two weeks; |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival will be calculated as time from start of study treatment to death due to any cause. | At end of trial- up to 3 years in follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From randomisation up to 3 years in follow up |
| Site of failure: local, regional or distant Failure |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Hoeppner, Professor | University Medical Center Schleswig-Holstein, Campus Lübeck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinik RWTH Aachen | Aachen | Germany | ||||
| Charité Berlin - Campus Benjamin Franklin (CBF) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27435280 | Background | Hoeppner J, Lordick F, Brunner T, Glatz T, Bronsert P, Rothling N, Schmoor C, Lorenz D, Ell C, Hopt UT, Siewert JR. ESOPEC: prospective randomized controlled multicenter phase III trial comparing perioperative chemotherapy (FLOT protocol) to neoadjuvant chemoradiation (CROSS protocol) in patients with adenocarcinoma of the esophagus (NCT02509286). BMC Cancer. 2016 Jul 19;16:503. doi: 10.1186/s12885-016-2564-y. | |
| 39842010 |
| Label | URL |
|---|---|
| ESOPEC Homepage | View source |
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| OTHER |
| University of Hamburg-Eppendorf | OTHER |
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| Leucovorin |
| Drug |
200 mg/m² in 250 ml NaCl 0.9%, d1 every two weeks; |
|
| Oxaliplatin | Drug | 85 mg/m² in 500 ml G5% over 2h, d1 every two weeks; |
|
| Docetaxel | Drug | 50mg/m2 in 250 ml NaCl 0.9% over 1h, d1 every two weeks; |
|
| Carboplatin | Drug | Dose-dependant: 2mg/ml/min AUC in 500ml Glucose 5%, day 1, 8, 15, 22 and day 29. |
|
| Paclitaxel | Drug | 50mg/m2 in 500ml NaCl 0.9% over 1 h, day 1, 8, 15, 22 and day 29; |
|
| Neoadjuvant radiation | Radiation | 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. |
|
| 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. | From time of surgery up to 3 years in follow up |
| Postsurgical Quality of Life | From randomization up to 3 years in follow up |
| Postoperative complications | From time of surgery up to 90 days postoperatively |
| Non-surgical site complications | From time of surgery up to 90 days postoperatively |
| Berlin |
| 12203 |
| Germany |
| Charité Berlin Campus Virchow-Klinikum (CVK) | Berlin | 13353 | Germany |
| Uniklinik Köln | Cologne | 50937 | Germany |
| Klinikum Dortmund gGmbH | Dortmund | 44137 | Germany |
| Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden | Dresden | 03107 | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | 60590 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Germany |
| Universitätsmedizin Göttingen | Göttingen | 37099 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| Universitätsklinikum des Saarlandes | Homburg | 66421 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | Germany |
| Universitätsklinikum Leipzig | Leipzig | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck | Lübeck | Germany |
| Universitätsklinikum Magdeburg | Magdeburg | Germany |
| Universitätsmedizin Mainz | Mainz | Germany |
| Universitätsklinikum Mannheim GmbH | Mannheim | 68167 | Germany |
| Johannes Wesling Klinikum Minden | Minden | 32429 | Germany |
| Klinikum der Universität München (LMU) | München | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Ruppiner Kliniken GmbH | Neuruppin | 16816 | Germany |
| Sana Klinikum Offenbach GmbH | Offenbach | 63069 | Germany |
| Universitätsklinikum Regensburg | Regensburg | 93053 | Germany |
| Universitätsmedizin Rostock | Rostock | 18059 | Germany |
| Klinikum Stuttgart | Stuttgart | 70174 | Germany |
| Robert-Bosch-Krankenhaus Stuttgart | Stuttgart | 70376 | Germany |
| Klinikum Mutterhaus | Trier | 54290 | Germany |
| Universitätsklinikum Würzburg | Würzburg | Germany |
| Derived |
| Hoeppner J, Brunner T, Schmoor C, Bronsert P, Kulemann B, Claus R, Utzolino S, Izbicki JR, Gockel I, Gerdes B, Ghadimi M, Reichert B, Lock JF, Bruns C, Reitsamer E, Schmeding M, Benedix F, Keck T, Folprecht G, Thuss-Patience P, Neumann UP, Pascher A, Imhof D, Daum S, Strieder T, Krautz C, Zimmermann S, Werner J, Mahlberg R, Illerhaus G, Grimminger P, Lordick F. Perioperative Chemotherapy or Preoperative Chemoradiotherapy in Esophageal Cancer. N Engl J Med. 2025 Jan 23;392(4):323-335. doi: 10.1056/NEJMoa2409408. |
| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
| D004938 | Esophageal Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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