ID

31205

Description

Stereotactic Precision And Conventional Radiotherapy Evaluation; ODM derived from: https://clinicaltrials.gov/show/NCT01920789

Link

https://clinicaltrials.gov/show/NCT01920789

Keywords

Versions (1)
  1. 7/28/18 7/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT01920789

English

Eligibility Non-small Cell Lung Cancer NCT01920789

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
non-small cell lung cancer stage i: t1-2 n0 m0.
Description

Non-Small Cell Lung Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
medically inoperable patients or patients refusing surgery.
Description

Patients Inoperable | Refused Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205187
UMLS CUI [2]
C0749192
morphologically verified. if that is impossible there must be increased tumour size in repeated ct scans and positive pet.
Description

Verification morphological | Tumor size Increased CT scans | Tumor size PET Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1711411
UMLS CUI [1,2]
C0543482
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C0205217
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C0475440
UMLS CUI [3,2]
C0032743
UMLS CUI [3,3]
C1514241
patients should have a life expectancy of > 6 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
who performance status 0-2.
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
signed written informed consent obtained.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patient should be feasible for both study arms.
Description

Patients Appropriate Protocol Arm Both

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1522541
UMLS CUI [1,4]
C1706086
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with central tumour growth adjacent to trachea, main bronchus or esophagus.
Description

Tumor growth Adjacent to Trachea | Tumor growth Adjacent to Main Bronchus | Tumor growth Adjacent to Esophagus

Data type

boolean

Alias
UMLS CUI [1,1]
C0598934
UMLS CUI [1,2]
C0205117
UMLS CUI [1,3]
C0040578
UMLS CUI [2,1]
C0598934
UMLS CUI [2,2]
C0205117
UMLS CUI [2,3]
C0024496
UMLS CUI [3,1]
C0598934
UMLS CUI [3,2]
C0205117
UMLS CUI [3,3]
C0014876
maximal tumour diameter > 6 cm.
Description

Tumor Diameter Maximal

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0806909
patients with prior malignancy within the last five years (except basal cell carcinoma of the skin or in situ carcinoma of the cervix).
Description

Malignant Neoplasms Previous | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
any prior antitumoral treatment of the present lung cancer.
Description

Prior Therapy Malignant neoplasm of lung Present

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0242379
UMLS CUI [1,3]
C0150312
previous irradiation that included part of the lung.
Description

Radiotherapy to lung Partial

Data type

boolean

Alias
UMLS CUI [1,1]
C0948315
UMLS CUI [1,2]
C0728938
pregnant women.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Non-small Cell Lung Cancer NCT01920789

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
non-small cell lung cancer stage i: t1-2 n0 m0.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Patients Inoperable | Refused Surgery
Item
medically inoperable patients or patients refusing surgery.
boolean
C0030705 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0749192 (UMLS CUI [2])
Verification morphological | Tumor size Increased CT scans | Tumor size PET Positive
Item
morphologically verified. if that is impossible there must be increased tumour size in repeated ct scans and positive pet.
boolean
C1711411 (UMLS CUI [1,1])
C0543482 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0475440 (UMLS CUI [3,1])
C0032743 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Life Expectancy
Item
patients should have a life expectancy of > 6 months.
boolean
C0023671 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-2.
boolean
C1298650 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent obtained.
boolean
C0021430 (UMLS CUI [1])
Patients Appropriate Protocol Arm Both
Item
patient should be feasible for both study arms.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,3])
C1706086 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Tumor growth Adjacent to Trachea | Tumor growth Adjacent to Main Bronchus | Tumor growth Adjacent to Esophagus
Item
patients with central tumour growth adjacent to trachea, main bronchus or esophagus.
boolean
C0598934 (UMLS CUI [1,1])
C0205117 (UMLS CUI [1,2])
C0040578 (UMLS CUI [1,3])
C0598934 (UMLS CUI [2,1])
C0205117 (UMLS CUI [2,2])
C0024496 (UMLS CUI [2,3])
C0598934 (UMLS CUI [3,1])
C0205117 (UMLS CUI [3,2])
C0014876 (UMLS CUI [3,3])
Tumor Diameter Maximal
Item
maximal tumour diameter > 6 cm.
boolean
C0027651 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Malignant Neoplasms Previous | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
patients with prior malignancy within the last five years (except basal cell carcinoma of the skin or in situ carcinoma of the cervix).
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Prior Therapy Malignant neoplasm of lung Present
Item
any prior antitumoral treatment of the present lung cancer.
boolean
C1514463 (UMLS CUI [1,1])
C0242379 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
Radiotherapy to lung Partial
Item
previous irradiation that included part of the lung.
boolean
C0948315 (UMLS CUI [1,1])
C0728938 (UMLS CUI [1,2])
Pregnancy
Item
pregnant women.
boolean
C0032961 (UMLS CUI [1])
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