Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  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

http://./.

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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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Organizational Data

  •   DRKS00008008
  •   2015/09/03
  •   2015/07/22
  •   yes
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Secondary IDs

  •   2015-001683-20 
  •   NCT02509286  (ClinicalTrials.gov)
  •   P000760  (University Hospital Freiburg)
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Health Condition or Problem studied

  •   Esophageal Adenocarcinoma (UICC TNM7)
  •   Adenocarcinoma of the Esophagogastric Junction
  •   C15 -  Malignant neoplasm of oesophagus
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Interventions/Observational Groups

  •   Drug: 5-Fluorouracil
  •   Drug: Leucovorin
  •   Drug: Oxaliplatin
  •   Drug: Docetaxel
  •   Drug: Carboplatin
  •   Drug: Paclitaxel
  •   Radiation: Neoadjuvant radiation
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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.

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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

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2016/01/31
  •   438
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   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

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    • University Hospital Freiburg
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    • Clinical Trials Unit Freiburg
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    • University Hospital Freiburg
    • Jens Hoeppner, Professor 
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    • Jens Hoeppner, Professor 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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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
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   210
  •   2017/12/11
* This entry means the parameter is not applicable or has not been set.