Trial document
DRKS00008008
Trial Description
Title
Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the Esophagus
Trial Acronym
ESOPEC
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.
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.
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
- DRKS00008008
- 2015/09/03
- 2015/07/22
- yes
- Approved
- 315/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Secondary IDs
- 2015-001683-20
- NCT02509286 (ClinicalTrials.gov)
- P000760 (University Hospital Freiburg)
Health Condition or Problem studied
- Esophageal Adenocarcinoma (UICC TNM7)
- Adenocarcinoma of the Esophagogastric Junction
- C15 - Malignant neoplasm of oesophagus
Interventions/Observational Groups
- Drug: 5-Fluorouracil
- Drug: Leucovorin
- Drug: Oxaliplatin
- Drug: Docetaxel
- Drug: Carboplatin
- Drug: Paclitaxel
- Radiation: Neoadjuvant radiation
Characteristics
- Interventional
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- Randomized controlled trial
- Open (masking not used)
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- Active control (effective treament of control group)
- Treatment
- Parallel
- III
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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.
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
Countries of Recruitment
- Germany
Locations of Recruitment
Recruitment
- Actual
- 2016/02/09
- 438
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
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
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
Addresses
-
start of 1:1-Block address primary-sponsor
- University Hospital Schleswig-Holstein
- Mr. Prof. Dr. med. Jens Höppner
- Ratzeburger Allee 160
- 23538 Luebeck
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49 451 500-40101
- +49 451 500 40104
- jens.hoeppner at uksk.de
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end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- Clinical Trials Unit Freiburg
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end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- University Hospital Schleswig-Holstein
- Mr. Prof. Dr. med. Jens Höppner
- Ratzeburger Allee 160
- 23538 Lübeck
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 451 500-40101
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- jens.hoeppner at uksk.de
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end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- University Hospital Schleswig-Holstein
- Mr. Prof. Dr. med. Jens Höppner,
- Ratzeburger Allee 160
- 23538 Lübeck
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 761 270-26970
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- jens.hoeppner at uksk.de
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end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- http://www.dfg.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up continuing
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- 438
- 438
Trial Publications, Results and other Documents
- ESOPEC Homepage
- Hoeppner J, Lordick F, Brunner T, Glatz T, Bronsert P, Röthling 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.; 27435280