ID

23446

Descrição

Responsible Party: Prof. Dr. Jens Hoeppner, Head of Upper GI Surgery Programm, University Hospital Freiburg ClinicalTrials.gov Identifier: NCT02509286 History of Changes Other Study ID Numbers: P000760 2015-001683-20 ( EudraCT Number ) DRKS00008008 ( Registry Identifier: DRKS ) Study First Received: July 22, 2015 Last Updated: April 12, 2017 Perioperative Chemotherapy Compared To Neoadjuvant Chemoradiation in Patients With Adenocarcinoma of the Esophagus (ESOPEC) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02509286

Link

https://clinicaltrials.gov/ct2/show/NCT02509286

Palavras-chave

  1. 04/07/2017 04/07/2017 -
Transferido a

4 de julho de 2017

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Esophagus Adenocarcinoma DRKS00008008 NCT02509286 DRKS00008008

Eligibility Esophagus Adenocarcinoma NCT02509286 DRKS00008008

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Histologically verified adenocarcinoma of the esophagus according to the UICC definition (TNM7)
Descrição

Esophageal carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0152018
Pre-treatment stage cT1N+, M0 or cT2-4a, N0/+, M0
Descrição

Pre-Treatment Stage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178759
UMLS CUI [1,2]
C2709094
Age ≥18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
No prior abdominal or thoracic radiotherapy
Descrição

Prior Radiotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279134
ECOG Performance status 0-2
Descrição

ECOG Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Adequate cardiac function ( Patients with a cardiac history (e.g. myocardial infarction, heart failure, coronary artery disease) should have a cardiology review)
Descrição

Cardiac function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232164
Adequate bone marrow function (WBC>3x10^9/l; Hb>9g/dl; platelets >100x10^9/l)
Descrição

Bone Marrow Function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
Adequate respiratory function. Symptomatic Patients should have pulmonary function tests with FEV1>1,5l )
Descrição

Pulmonary Function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0231921
Adequate renal function (GFR >60ml/min)
Descrição

Renal Function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
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)
Descrição

Liver Function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
Written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Tumors of squamous or other non-adenocarcinoma histology
Descrição

Histological finding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0449575
Patients with advanced inoperable or metastatic esophageal adenocarcinoma
Descrição

Inoperable Tumor, Metastatic Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0205187
UMLS CUI [2]
C0027627
Stage cT1N0 and cT4b
Descrição

Tumor Stage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1300072
Gastric carcinoma
Descrição

Stomach Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0699791
Prior chemotherapy for cancer,
Descrição

Prior chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514457
Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months)
Descrição

Cardiac Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018799
Clinical significant lung disease (FEV 1<1,5l)
Descrição

Lung Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024115
Peripheral neuropathy Grade >1
Descrição

Neuropathy Grade

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0441800
Healthy Volunteers
Descrição

Control Group

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009932

Similar models

Eligibility Esophagus Adenocarcinoma NCT02509286 DRKS00008008

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Esophageal carcinoma
Item
Histologically verified adenocarcinoma of the esophagus according to the UICC definition (TNM7)
boolean
C0152018 (UMLS CUI [1])
Pre-Treatment Stage
Item
Pre-treatment stage cT1N+, M0 or cT2-4a, N0/+, M0
boolean
C0178759 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
Age
Item
Age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Prior Radiotherapy
Item
No prior abdominal or thoracic radiotherapy
boolean
C0279134 (UMLS CUI [1])
ECOG Performance Status
Item
ECOG Performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Cardiac function
Item
Adequate cardiac function ( Patients with a cardiac history (e.g. myocardial infarction, heart failure, coronary artery disease) should have a cardiology review)
boolean
C0232164 (UMLS CUI [1])
Bone Marrow Function
Item
Adequate bone marrow function (WBC>3x10^9/l; Hb>9g/dl; platelets >100x10^9/l)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Pulmonary Function
Item
Adequate respiratory function. Symptomatic Patients should have pulmonary function tests with FEV1>1,5l )
boolean
C0231921 (UMLS CUI [1])
Renal Function
Item
Adequate renal function (GFR >60ml/min)
boolean
C0232804 (UMLS CUI [1])
Liver Function
Item
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)
boolean
C0232741 (UMLS CUI [1])
Informed Consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Histological finding
Item
Tumors of squamous or other non-adenocarcinoma histology
boolean
C0449575 (UMLS CUI [1])
Inoperable Tumor, Metastatic Disease
Item
Patients with advanced inoperable or metastatic esophageal adenocarcinoma
boolean
C0205187 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Tumor Stage
Item
Stage cT1N0 and cT4b
boolean
C1300072 (UMLS CUI [1])
Stomach Carcinoma
Item
Gastric carcinoma
boolean
C0699791 (UMLS CUI [1])
Prior chemotherapy
Item
Prior chemotherapy for cancer,
boolean
C1514457 (UMLS CUI [1])
Cardiac Disease
Item
Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months)
boolean
C0018799 (UMLS CUI [1])
Lung Disease
Item
Clinical significant lung disease (FEV 1<1,5l)
boolean
C0024115 (UMLS CUI [1])
Neuropathy Grade
Item
Peripheral neuropathy Grade >1
boolean
C0442874 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])

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