Trial document

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DRKS-ID: DRKS00008008

Trial Description

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Title

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

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Trial Acronym

ESOPEC

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00008008
Date of Registration in DRKS: 2015/09/03
Date of Registration in Partner Registry or other Primary Registry: 2015/07/22
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 315/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

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Secondary IDs

EudraCT-No. (for studies acc. to Drug Law): 2015-001683-20
Primary Registry-ID: NCT02509286 (ClinicalTrials.gov)
Sponsor-ID: P000760 (University Hospital Freiburg)

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Health Condition or Problem studied

Free text: Esophageal Adenocarcinoma (UICC TNM7)
Free text: Adenocarcinoma of the Esophagogastric Junction
ICD10: C15 - Malignant neoplasm of oesophagus

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Interventions/Observational Groups

Arm 1: Drug: 5-Fluorouracil
Arm 2: Drug: Leucovorin
Arm 3: Drug: Oxaliplatin
Arm 4: Drug: Docetaxel
Arm 5: Drug: Carboplatin
Arm 6: Drug: Paclitaxel
Arm 7: Radiation: Neoadjuvant radiation

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Active control (effective treament of control group)
Purpose: Treatment
Assignment: Parallel
Phase: III
Off-label Drug use: [---]*

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Primary Outcome

- 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.

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Secondary Outcome

- 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.
- 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; 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.
- 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

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

Uniklinik RWTH Aachen, Aachen
Charité Berlin - Campus Benjamin Franklin (CBF), Berlin
Charité Berlin Campus Virchow-Klinikum (CVK), Berlin
Klinikum Dortmund gGmbH, Dortmund
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden
Universitätsklinikum Düsseldorf, Düsseldorf
Universitätsklinikum Erlangen, Erlangen
Universitätsklinikum Frankfurt, Frankfurt am Main
Universitätsklinikum Freiburg, Freiburg
Universitätsmedizin Göttingen, Göttingen
Universitätsklinikum Hamburg-Eppendorf, Hamburg
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel
Uniklinik Köln, Köln
Universitätsklinikum Leipzig, Leipzig
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck
Universitätsklinikum Magdeburg, Magdeburg
Universitätsmedizin Mainz, Mainz
Johannes Wesling Klinikum Minden, Minden
Klinikum der Universität München (LMU), München
Universitätsklinikum Münster, Münster
Sana Klinikum Offenbach GmbH, Offenbach
Klinikum Stuttgart, Stuttgart
Robert-Bosch-Krankenhaus Stuttgart, Stuttgart
Klinikum Mutterhaus, Trier
Universitätsklinikum Würzburg, Würzburg

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2016/02/09
Target Sample Size: 438
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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Additional Inclusion 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>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:

- 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

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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

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Addresses

Primary Sponsor
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- University Hospital Schleswig-Holstein
- Mr. Prof. Dr. med. Jens Höppner
- Ratzeburger Allee 160
- 23538 Luebeck
- Germany
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- Telephone: +49 451 500-40101
- Fax: +49 451 500 40104
- E-mail: jens.hoeppner at uksk.de
- URL: [---]*
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Collaborator, Other Address
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- Clinical Trials Unit Freiburg
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- University Hospital Schleswig-Holstein
- Mr. Prof. Dr. med. Jens Höppner
- Ratzeburger Allee 160
- 23538 Lübeck
- Germany
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- Telephone: +49 451 500-40101
- Fax: [---]*
- E-mail: jens.hoeppner at uksk.de
- URL: [---]*
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Contact for Public Queries
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- University Hospital Schleswig-Holstein
- Mr. Prof. Dr. med. Jens Höppner,
- Ratzeburger Allee 160
- 23538 Lübeck
- Germany
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- Telephone: +49 761 270-26970
- Fax: [---]*
- E-mail: jens.hoeppner at uksk.de
- URL: [---]*
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.dfg.de
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Status

Recruitment Status: Recruiting complete, follow-up continuing
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): [---]*
Number of Participants in Germany after Recruiting complete: 438
Total Number of Participants (all Sites worldwide) after Recruiting complete: 438

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Trial Publications, Results and other Documents

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