ID

35151

Description

A Pilot Study of Response-Driven Adaptive Radiation Therapy for Patients With Locally Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02492867

Link

https://clinicaltrials.gov/show/NCT02492867

Keywords

Versions (1)
  1. 2/20/19 2/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT02492867

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT02492867

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have fdg-avid and pathologically proven stage iia-iiib non-small cell lung cancer.
Description

FDG Avidity | Non-Small Cell Lung Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0046056
UMLS CUI [1,2]
C1510996
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
patients must be considered unresectable or inoperable.
Description

Patients unresectable | Patients Inoperable

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0205187
patients must be 18 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must have a karnofsky performance (a measure general well-being and activities of daily life. scores range between 0 and 100 where 100 represents normal and 0 represents death.) of score > or = to 70.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
patients must have adequate organ and marrow function.
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
patient must be willing to use effective contraception if female with reproductive capability.
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with any component of small cell lung carcinoma
Description

Small cell carcinoma of lung Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0149925
UMLS CUI [1,2]
C1705248
patients with evidence of a malignant pleural or pericardial effusion
Description

Pleural Effusion, Malignant | Malignant pericardial effusion

Data type

boolean

Alias
UMLS CUI [1]
C0080032
UMLS CUI [2]
C0220655
prior radiotherapy to the thorax such that composite radiation would significantly overdose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints
Description

Radiotherapy to thorax | Overdose Structures Critical

Data type

boolean

Alias
UMLS CUI [1]
C4038705
UMLS CUI [2,1]
C4018909
UMLS CUI [2,2]
C0678594
UMLS CUI [2,3]
C1511545
patients cannot tolerate concurrent chemotherapy
Description

Chemotherapy Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.
Description

Pregnancy | Therapeutic radiology procedure Teratogenic effect | Therapeutic radiology procedure Abortifacient Effect

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0232910
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C3179338
prisoners are excluded for this study.
Description

Prisoners

Data type

boolean

Alias
UMLS CUI [1]
C0033167
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02492867

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
FDG Avidity | Non-Small Cell Lung Carcinoma TNM clinical staging
Item
patients must have fdg-avid and pathologically proven stage iia-iiib non-small cell lung cancer.
boolean
C0046056 (UMLS CUI [1,1])
C1510996 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Patients unresectable | Patients Inoperable
Item
patients must be considered unresectable or inoperable.
boolean
C0030705 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
Age
Item
patients must be 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
patients must have a karnofsky performance (a measure general well-being and activities of daily life. scores range between 0 and 100 where 100 represents normal and 0 represents death.) of score > or = to 70.
boolean
C0206065 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
patients must have adequate organ and marrow function.
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods
Item
patient must be willing to use effective contraception if female with reproductive capability.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Small cell carcinoma of lung Component
Item
patients with any component of small cell lung carcinoma
boolean
C0149925 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
Pleural Effusion, Malignant | Malignant pericardial effusion
Item
patients with evidence of a malignant pleural or pericardial effusion
boolean
C0080032 (UMLS CUI [1])
C0220655 (UMLS CUI [2])
Radiotherapy to thorax | Overdose Structures Critical
Item
prior radiotherapy to the thorax such that composite radiation would significantly overdose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints
boolean
C4038705 (UMLS CUI [1])
C4018909 (UMLS CUI [2,1])
C0678594 (UMLS CUI [2,2])
C1511545 (UMLS CUI [2,3])
Chemotherapy Receive Unable
Item
patients cannot tolerate concurrent chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Pregnancy | Therapeutic radiology procedure Teratogenic effect | Therapeutic radiology procedure Abortifacient Effect
Item
pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.
boolean
C0032961 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0232910 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C3179338 (UMLS CUI [3,2])
Prisoners
Item
prisoners are excluded for this study.
boolean
C0033167 (UMLS CUI [1])
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