ID

30267

Description

Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00843726

Link

https://clinicaltrials.gov/show/NCT00843726

Keywords

Versions (1)
  1. 5/25/18 5/25/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 25, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00843726

English

Eligibility Lung Cancer NCT00843726

1 forms  
Criteria
Description

Criteria

histologically confirmed non-small cell lung cancer
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
node-negative disease
Description

Disease Negative Lymph Node

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0678034
peripheral disease
Description

Peripheral Arterial Disease

Data type

boolean

Alias
UMLS CUI [1]
C1704436
t1-t3, n0 disease measuring ≤ 5 cm
Description

Measurable Disease Size TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C3258246
no t2-t3 tumors > 5 cm or t3 tumor based on chest wall involvement
Description

Exclusion Criteria | Tumor Size TNM clinical staging | Tumor TNM clinical staging Chest wall Involvement

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C3258246
UMLS CUI [3,3]
C0205076
UMLS CUI [3,4]
C1314939
surgically resectable primary disease, but patient refuses surgery or is deemed to be medically inoperable
Description

Primary disorder Resectable | Operative Surgical Procedures Refused | Patient assessment Inoperable

Data type

boolean

Alias
UMLS CUI [1,1]
C0277554
UMLS CUI [1,2]
C1514888
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1705116
UMLS CUI [3,1]
C0679830
UMLS CUI [3,2]
C0205187
no metastatic disease
Description

Exclusion Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0027627
no tumor within the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions
Description

Exclusion Tumor Bronchial tree Proximal | Tumor Volume

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C0819141
UMLS CUI [1,4]
C0205107
UMLS CUI [2]
C0475276
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
not pregnant
Description

Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
negative pregnancy test
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no other conditions deemed by the pi or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
Description

Exclusion Criteria | Condition Study Subject Participation Status Ineligible | Protocol Compliance Unable | Patient Inappropriate External Beam Radiation Therapy High dose

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1512714
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C1517033
UMLS CUI [4,4]
C0444956
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
no prior thoracic radiotherapy
Description

Radiotherapy to thorax Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4038705
UMLS CUI [1,2]
C0332197
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Similar models

Eligibility Lung Cancer NCT00843726

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-Small Cell Lung Carcinoma
Item
histologically confirmed non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Disease Negative Lymph Node
Item
node-negative disease
boolean
C0012634 (UMLS CUI [1,1])
C0678034 (UMLS CUI [1,2])
Peripheral Arterial Disease
Item
peripheral disease
boolean
C1704436 (UMLS CUI [1])
Measurable Disease Size TNM clinical staging
Item
t1-t3, n0 disease measuring ≤ 5 cm
boolean
C1513041 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Exclusion Criteria | Tumor Size TNM clinical staging | Tumor TNM clinical staging Chest wall Involvement
Item
no t2-t3 tumors > 5 cm or t3 tumor based on chest wall involvement
boolean
C0680251 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C0205076 (UMLS CUI [3,3])
C1314939 (UMLS CUI [3,4])
Primary disorder Resectable | Operative Surgical Procedures Refused | Patient assessment Inoperable
Item
surgically resectable primary disease, but patient refuses surgery or is deemed to be medically inoperable
boolean
C0277554 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
C0679830 (UMLS CUI [3,1])
C0205187 (UMLS CUI [3,2])
Exclusion Neoplasm Metastasis
Item
no metastatic disease
boolean
C2828389 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Exclusion Tumor Bronchial tree Proximal | Tumor Volume
Item
no tumor within the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions
boolean
C2828389 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0819141 (UMLS CUI [1,3])
C0205107 (UMLS CUI [1,4])
C0475276 (UMLS CUI [2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Pregnancy Absent
Item
not pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion Criteria | Condition Study Subject Participation Status Ineligible | Protocol Compliance Unable | Patient Inappropriate External Beam Radiation Therapy High dose
Item
no other conditions deemed by the pi or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
boolean
C0680251 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1512714 (UMLS CUI [2,3])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1517033 (UMLS CUI [4,3])
C0444956 (UMLS CUI [4,4])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Radiotherapy to thorax Absent
Item
no prior thoracic radiotherapy
boolean
C4038705 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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