ESOPEC

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

Programme: This Project is not associated with a Programme

SEEK ID: https://ldh.zks-freiburg.imise.uni-leipzig.de/projects/2

Public web page: Not specified

NFDI4Health PALs: No PALs for this Project

Project start date: 9th Feb 2016

Project end date: 28th Nov 2023

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : nfdi4health-29983

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the Esophagus
Language of the title/name : English

Title/name : Perioperative Chemotherapie (FLOT Protocol) im Vergleich zur neoadjuvanten Radiochemotherapie (CROSS Protocol) bei Patienten mit einem Adenokarzinom des Ösophagus
Language of the title/name : German

Acronym(s) of the Project

Acronym : ESOPEC
Language of the acronym : English

Description(s) of the Project

Description : Diese Studie ist entworfen, um Unterschiede der Ergebnisse von Patienten mit Tumoren des Drüsengewebes der Speiseröhre und Tumore des Drüsengewebes des Übergangs von Speiseröhre zu Magen mit perioperativer (neoadjuvanter + adjuvanter) Chemotherapie (FLOT) plus chirurgischer Entfernung versus neoadjuvante Chemoradiation vor dem chirurgischen Eingriff (CROSS) plus chirurgischer Entfernung zu untersuchen.
Language of the description : German

Keyword(s) describing the Project

Keyword(*) : Ösophageales Adenokarzinom, FLOT, CROSS

Language(s) of the project : German

Web page of the project : https://www.uniklinik-freiburg.de/esopec-studie.html

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Contact
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Universitätsklinikum Freiburg
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : info@uniklinik-freiburg.de
Phone number : +49 761 270-0
Organisation(s) associated with the contributor
Name(*) : Universitätsklinikum Freiburg, Zentrum Klinischer Studien
Address : Elsässer Str. 2, 79110, Freiburg, Deutschland
Web page : https://www.uniklinik-freiburg.de/zks.html
Digital identifier(s)
Identifier(*) : 03vzbgh69
Scheme(*) : ROR

Alternative identifiers

Type of the registry(*) : DRKS
Identifier(*) : DRKS00008008

Type of the registry(*) : NCT (ClinicalTrials.gov)
Identifier(*) : NCT02509286

Type of the registry(*) : EudraCT
Identifier(*) : 2015-001683-20

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Ösophageales Adenokarzinom
Terminology/classification(*) : ICD-10
Code of the health condition or disease : C15
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Neoplasms (II)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : Not specified
Start date : 9 February 2016
End date : 28 November 2023
Mono- or multicentric? : Multicentric
Number of centers : 32
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Male, Female, Diverse
Inclusion criteria : - Histologisch verifiziertes Adenokarzinom des Ösophagus laut der UICC TNM7 Definition; - Präbehandlungsstadium cT1N+ M0 oder cT2-4a N0/N+, M0; - Alter ≥ 18 Jahre; - Keine vorherige abdominelle oder thorakale Radiotherapie; - ECOG Performancestatus 0-2; - Adäquate Herzfunktion. Patienten mit einer kardialen Anamnese (z.B. Myokardinfarkt, Herzinsuffizienz, koronarer Herzerkrankung) sollten eine kardiologische Überprüfung; - Adäquate Knochenmarksfunktion: (WBC>3x10^9/l; Hb>9g/dl, Thrombozyten >100x10^9/l); - Adäquate respiratorische Funktion, Symptomatische Patienten sollten einen Lungenfunktionstest mit FEV1>1,5l vorweisen; - Adäquate Nierenfunktion (GFR>60ml/min); - Adäquate Leberfunktion (Serumbilirubin <1,5x obere Normgrenze (ULN); - AST <2,5x ULN und ALT <3x ULN (ULN gemäß Institutsstandard); - schriftliche Einverständniserklärung
Exclusion criteria : - Tumoren mit Plattenepithel-, adenosquamöser oder anderer nicht Adenokarzinomhistologie; - Patienten mit fortgeschrittenen inoperablen oder metastasierten ösophagealen Adenokarzinomen; - Stadium cT1N0 und cT4b; - Gastrisches Karzinom; - Vorherige Chemotherapie gegen Krebs; - Klinisch signifikante (d.h. aktive) Herzerkrankung (z.B. symptomatische Erkrankung der Koronararterien oder Myokardinfarkt innerhalb der letzten 12 Monate); - Klinisch signifikante Lungenerkrankung (FEV1 <1,5l); - Periphere Neuropathie Grad >1
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : perioperativer (neoadjuvanter + adjuvanter) Chemotherapie (FLOT) plus chirurgischer Entfernung
Type of the intervention : Drug (including placebo)
Additional information about the intervention : 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.
Name(s) of the arm(s) associated with the given intervention : Not specified
Name of the intervention(*) : neoadjuvante Chemoradiation vor dem chirurgischen Eingriff (CROSS) plus chirurgischer Entfernung
Type of the intervention : Drug (including placebo)
Additional information about the intervention : 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(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Overall survival
Description of the outcome measure : Overall survival will be calculated as time from start of study treatment to death due to any cause.
Type of the outcome measure : Primary
Time point(s) of assessment : up to 3 years in follow up
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Undecided, it is not yet known if data will be made available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Phase-3
Masking of intervention(s) assignment
Masking implemented? : false
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Randomized
Off-label use of a drug product : Not specified

ESOPEC

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