ID

36675

Description

Locally Invasive NSCLC Treated With NEo-Adjuvant Stereotactic Body RadioTherapy and REsection; ODM derived from: https://clinicaltrials.gov/show/NCT02433574

Link

https://clinicaltrials.gov/show/NCT02433574

Keywords

Versions (1)
  1. 5/31/19 5/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small-Cell Lung Cancer NCT02433574

English

Eligibility Non-Small-Cell Lung Cancer NCT02433574

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients will be included if they are aged 18 years or older,
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
with biopsy proven nsclc,
Description

Non-Small Cell Lung Carcinoma Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0005558
clinically staged t3-t4 marginally resectable i.e. deemed at risk to achieve <r0 resection (such as invasion of critical mediastinal or hilar structures, nodal extra-capsular extension, chest wall, vertebral bodies, compromised bronchial stump margin, based on ct images of the chest).
Description

TNM clinical staging Resectable Marginal

Data type

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C0205284
patients also need to be pathologically staged n0-1 disease,
Description

Disease Pathologic TNM stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1319019
with an sbrt ctv≤200cm3, based on planning ct images.
Description

Stereotactic Body Radiation Therapy Clinical target volume | CT Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C3896609
UMLS CUI [1,2]
C0454198
UMLS CUI [2,1]
C0040405
UMLS CUI [2,2]
C1301732
ecog status is required to be <2 within 4 weeks prior to registration and
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must be deemed medically operable by the surgical team.
Description

Patient Operable

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205188
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded if they are deemed medically inoperable by the surgical team
Description

Patient Inoperable

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205187
and have a weight loss of ≥10% within 3 months prior to pathological diagnosis.
Description

Weight loss Percentage Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
patients will also have no absolute contraindication to rt such as connective tissue disease, pacemaker-dependent patient with the pacemaker receiving higher than tolerance dose, had no had previous rt to the current region of the study, that would result in overlap of rt fields,
Description

Medical contraindication Therapeutic radiology procedure | Connective Tissue Diseases | Dependence on Artificial cardiac pacemaker | Prior radiation therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1522449
UMLS CUI [2]
C0009782
UMLS CUI [3,1]
C0439857
UMLS CUI [3,2]
C0030163
UMLS CUI [4,1]
C0279134
UMLS CUI [4,2]
C0332197
patients must have no plans to receive other local therapy while on study, except at disease progression,
Description

Local Therapy Other Absent | Exception Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0242656
patients have not had other malignancy within 2 years prior to the study (other than non-melanomatous skin cancers)
Description

Cancer Other Absent | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
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Similar models

Eligibility Non-Small-Cell Lung Cancer NCT02433574

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients will be included if they are aged 18 years or older,
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Biopsy
Item
with biopsy proven nsclc,
boolean
C0007131 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
TNM clinical staging Resectable Marginal
Item
clinically staged t3-t4 marginally resectable i.e. deemed at risk to achieve <r0 resection (such as invasion of critical mediastinal or hilar structures, nodal extra-capsular extension, chest wall, vertebral bodies, compromised bronchial stump margin, based on ct images of the chest).
boolean
C3258246 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0205284 (UMLS CUI [1,3])
Disease Pathologic TNM stage
Item
patients also need to be pathologically staged n0-1 disease,
boolean
C0012634 (UMLS CUI [1,1])
C1319019 (UMLS CUI [1,2])
Stereotactic Body Radiation Therapy Clinical target volume | CT Planned
Item
with an sbrt ctv≤200cm3, based on planning ct images.
boolean
C3896609 (UMLS CUI [1,1])
C0454198 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
ECOG performance status
Item
ecog status is required to be <2 within 4 weeks prior to registration and
boolean
C1520224 (UMLS CUI [1])
Patient Operable
Item
patients must be deemed medically operable by the surgical team.
boolean
C0030705 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Patient Inoperable
Item
patients will be excluded if they are deemed medically inoperable by the surgical team
boolean
C0030705 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
Weight loss Percentage Timespan
Item
and have a weight loss of ≥10% within 3 months prior to pathological diagnosis.
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Medical contraindication Therapeutic radiology procedure | Connective Tissue Diseases | Dependence on Artificial cardiac pacemaker | Prior radiation therapy Absent
Item
patients will also have no absolute contraindication to rt such as connective tissue disease, pacemaker-dependent patient with the pacemaker receiving higher than tolerance dose, had no had previous rt to the current region of the study, that would result in overlap of rt fields,
boolean
C1301624 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0009782 (UMLS CUI [2])
C0439857 (UMLS CUI [3,1])
C0030163 (UMLS CUI [3,2])
C0279134 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Local Therapy Other Absent | Exception Disease Progression
Item
patients must have no plans to receive other local therapy while on study, except at disease progression,
boolean
C1517925 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
Cancer Other Absent | Exception Skin carcinoma
Item
patients have not had other malignancy within 2 years prior to the study (other than non-melanomatous skin cancers)
boolean
C1707251 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
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