ID

41558

Beschreibung

3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01563354 according to the information on clinicaltrials.gov "other protocol-defined inclusion/exclusion-criteria may apply"

Link

https://clinicaltrials.gov/show/NCT01563354

Stichworte

Versionen (1)
  1. 10.11.20 10.11.20 -
Rechteinhaber

see on clinicaltrials.gov

Hochgeladen am

10. November 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Neuroendocrine Carcinoma of the Lung and Thymus NCT01563354

Englisch

Eligibility Neuroendocrine Carcinoma of the Lung and Thymus NCT01563354

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological confirmed advanced well differentiated typical and atypical carcinoid tumors of the lung or thymus
Beschreibung

histological confirmed advanced well differentiated carcinoid tumors of the lung or thymus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449575
UMLS CUI [1,2]
C0205615
UMLS CUI [1,3]
C0280089
UMLS CUI [1,4]
C0205179
UMLS CUI [2,1]
C0449575
UMLS CUI [2,2]
C0205615
UMLS CUI [2,3]
C0007095
UMLS CUI [2,4]
C0040113
UMLS CUI [2,5]
C0205179
patients of all treatment lines including naive patients can be enrolled
Beschreibung

patients of all treatment lines including naive patients

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2200127
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0206695
UMLS CUI [2,3]
C0040113
UMLS CUI [3,1]
C0332155
UMLS CUI [3,2]
C2200127
UMLS CUI [4,1]
C0332155
UMLS CUI [4,2]
C0206695
UMLS CUI [4,3]
C0040113
at least one measurable lesion of disease on ct scan or mri
Beschreibung

at least one measurable lesion of disease on ct scan or mri

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0040405
UMLS CUI [1,3]
C2200127
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0024485
UMLS CUI [2,3]
C2200127
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0040405
UMLS CUI [3,3]
C0206695
UMLS CUI [3,4]
C0040113
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0024485
UMLS CUI [4,3]
C0206695
UMLS CUI [4,4]
C0040113
radiological documentation of disease progression within 12 months prior to randomization
Beschreibung

radiological documentation of disease progression prior to randomization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C1290916
UMLS CUI [1,3]
C0242656
adequate liver, renal and bone marrow function
Beschreibung

adequate liver, renal and bone marrow function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205410
UMLS CUI [1,2]
C0232741
UMLS CUI [2,1]
C0205410
UMLS CUI [2,2]
C0232804
UMLS CUI [3,1]
C0205410
UMLS CUI [3,2]
C0005953
UMLS CUI [3,3]
C0678852
who performance status 0-2
Beschreibung

who performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
poorly differentiated neuroendocrine carcinoma
Beschreibung

poorly differentiated neuroendocrine carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205617
UMLS CUI [1,2]
C0206695
non-neuroendocrine thymoma
Beschreibung

non-neuroendocrine thymoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040100
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0206695
patients with severe functional disease requiring symptomatic treatment with somatostatin analogs
Beschreibung

patients with severe functional disease requiring treatment with somatostatin analogs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277785
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0732165
prior therapy with mtor inhibitors
Beschreibung

prior therapy with mtor inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2746052
history of liver disease
Beschreibung

history of liver disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0023895
baseline qtcf> 470 msec
Beschreibung

baseline qtcf

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C1882513
uncontrolled diabetes mellitus despite adequate therapy
Beschreibung

uncontrolled diabetes mellitus despite adequate therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0205411
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Ähnliche Modelle

Eligibility Neuroendocrine Carcinoma of the Lung and Thymus NCT01563354

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
histological confirmed advanced well differentiated carcinoid tumors of the lung or thymus
Item
histological confirmed advanced well differentiated typical and atypical carcinoid tumors of the lung or thymus
boolean
C0449575 (UMLS CUI [1,1])
C0205615 (UMLS CUI [1,2])
C0280089 (UMLS CUI [1,3])
C0205179 (UMLS CUI [1,4])
C0449575 (UMLS CUI [2,1])
C0205615 (UMLS CUI [2,2])
C0007095 (UMLS CUI [2,3])
C0040113 (UMLS CUI [2,4])
C0205179 (UMLS CUI [2,5])
patients of all treatment lines including naive patients
Item
patients of all treatment lines including naive patients can be enrolled
boolean
C0087111 (UMLS CUI [1,1])
C2200127 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0206695 (UMLS CUI [2,2])
C0040113 (UMLS CUI [2,3])
C0332155 (UMLS CUI [3,1])
C2200127 (UMLS CUI [3,2])
C0332155 (UMLS CUI [4,1])
C0206695 (UMLS CUI [4,2])
C0040113 (UMLS CUI [4,3])
at least one measurable lesion of disease on ct scan or mri
Item
at least one measurable lesion of disease on ct scan or mri
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C2200127 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C2200127 (UMLS CUI [2,3])
C1513041 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C0206695 (UMLS CUI [3,3])
C0040113 (UMLS CUI [3,4])
C1513041 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0206695 (UMLS CUI [4,3])
C0040113 (UMLS CUI [4,4])
radiological documentation of disease progression prior to randomization
Item
radiological documentation of disease progression within 12 months prior to randomization
boolean
C0332185 (UMLS CUI [1,1])
C1290916 (UMLS CUI [1,2])
C0242656 (UMLS CUI [1,3])
adequate liver, renal and bone marrow function
Item
adequate liver, renal and bone marrow function
boolean
C0205410 (UMLS CUI [1,1])
C0232741 (UMLS CUI [1,2])
C0205410 (UMLS CUI [2,1])
C0232804 (UMLS CUI [2,2])
C0205410 (UMLS CUI [3,1])
C0005953 (UMLS CUI [3,2])
C0678852 (UMLS CUI [3,3])
who performance status
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
poorly differentiated neuroendocrine carcinoma
Item
poorly differentiated neuroendocrine carcinoma
boolean
C0205617 (UMLS CUI [1,1])
C0206695 (UMLS CUI [1,2])
non-neuroendocrine thymoma
Item
non-neuroendocrine thymoma
boolean
C0040100 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0206695 (UMLS CUI [1,3])
patients with severe functional disease requiring treatment with somatostatin analogs
Item
patients with severe functional disease requiring symptomatic treatment with somatostatin analogs
boolean
C0277785 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0732165 (UMLS CUI [1,4])
prior therapy with mtor inhibitors
Item
prior therapy with mtor inhibitors
boolean
C1514463 (UMLS CUI [1,1])
C2746052 (UMLS CUI [1,2])
history of liver disease
Item
history of liver disease
boolean
C0262926 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
baseline qtcf
Item
baseline qtcf> 470 msec
boolean
C1442488 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
uncontrolled diabetes mellitus despite adequate therapy
Item
uncontrolled diabetes mellitus despite adequate therapy
boolean
C0011849 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0205411 (UMLS CUI [1,4])
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