ID

36601

Description

Functional Lung Avoidance for Individualized Radiotherapy (FLAIR): A Randomized, Double-Blind Clinical Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02002052

Link

https://clinicaltrials.gov/show/NCT02002052

Keywords

Versions (1)
  1. 5/25/19 5/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02002052

English

Eligibility Non-small Cell Lung Cancer NCT02002052

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
willing to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
histologically confirmed non-small cell lung carcinoma
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
locally advanced stage iiia or iiib lung carcinoma according to ajcc 7th edition
Description

Carcinoma of lung Advanced Locally TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0684249
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C3258246
history of at least 10-pack-years of smoking
Description

Tobacco use Cigarette pack-years

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C1303175
not undergoing surgical resection
Description

Excision Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0332197
assessment by medical oncologist and radiation oncologist, with adequate bone marrow, hepatic and renal function for administration of platinum-based chemotherapy
Description

Assessment Clinical oncologist | Assessment Radiation Oncologist | Bone Marrow function | Liver function | Renal function | Chemotherapy Platinum-Based

Data type

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0586804
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C1514693
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
UMLS CUI [4]
C0232741
UMLS CUI [5]
C0232804
UMLS CUI [6,1]
C0392920
UMLS CUI [6,2]
C1514162
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to mri
Description

Medical contraindication MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
serious medical comorbidities (such as unstable angina, sepsis) or other contraindications to radiotherapy or chemotherapy
Description

Comorbidity Serious | Angina, Unstable | Sepsis | Medical contraindication Therapeutic radiology procedure | Medical contraindication Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0243026
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C1522449
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0392920
prior history of lung cancer within 5 years
Description

Carcinoma of lung Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0684249
UMLS CUI [1,2]
C0205156
prior thoracic radiation at any time
Description

Radiotherapy to thorax

Data type

boolean

Alias
UMLS CUI [1]
C4038705
metastatic disease. patients who present with oligometastatic disease where all metastases have been ablated (with surgery or radiotherapy) are candidates if they are receiving chemoradiotherapy to the thoracic disease with curative intent.
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
inability to attend full course of radiotherapy or follow-up visits
Description

Therapeutic radiology procedure Unable | Follow-up visit Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0589121
UMLS CUI [2,2]
C1299582
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02002052

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willing to provide informed consent
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma
Item
histologically confirmed non-small cell lung carcinoma
boolean
C0007131 (UMLS CUI [1])
Carcinoma of lung Advanced Locally TNM clinical staging
Item
locally advanced stage iiia or iiib lung carcinoma according to ajcc 7th edition
boolean
C0684249 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
Tobacco use Cigarette pack-years
Item
history of at least 10-pack-years of smoking
boolean
C0543414 (UMLS CUI [1,1])
C1303175 (UMLS CUI [1,2])
Excision Absent
Item
not undergoing surgical resection
boolean
C0728940 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Assessment Clinical oncologist | Assessment Radiation Oncologist | Bone Marrow function | Liver function | Renal function | Chemotherapy Platinum-Based
Item
assessment by medical oncologist and radiation oncologist, with adequate bone marrow, hepatic and renal function for administration of platinum-based chemotherapy
boolean
C1516048 (UMLS CUI [1,1])
C0586804 (UMLS CUI [1,2])
C1516048 (UMLS CUI [2,1])
C1514693 (UMLS CUI [2,2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
C0232741 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0392920 (UMLS CUI [6,1])
C1514162 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication MRI
Item
contraindications to mri
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Comorbidity Serious | Angina, Unstable | Sepsis | Medical contraindication Therapeutic radiology procedure | Medical contraindication Chemotherapy
Item
serious medical comorbidities (such as unstable angina, sepsis) or other contraindications to radiotherapy or chemotherapy
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0243026 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
Carcinoma of lung Previous
Item
prior history of lung cancer within 5 years
boolean
C0684249 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Radiotherapy to thorax
Item
prior thoracic radiation at any time
boolean
C4038705 (UMLS CUI [1])
Neoplasm Metastasis
Item
metastatic disease. patients who present with oligometastatic disease where all metastases have been ablated (with surgery or radiotherapy) are candidates if they are receiving chemoradiotherapy to the thoracic disease with curative intent.
boolean
C0027627 (UMLS CUI [1])
Therapeutic radiology procedure Unable | Follow-up visit Unable
Item
inability to attend full course of radiotherapy or follow-up visits
boolean
C1522449 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0589121 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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