ID

36675

Descripción

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

Palabras clave

Versiones (1)
  1. 31/5/19 31/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

31 de mayo de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Non-Small-Cell Lung Cancer NCT02433574

Inglés

Eligibility Non-Small-Cell Lung Cancer NCT02433574

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

boolean

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

Non-Small Cell Lung Carcinoma Biopsy

Tipo de datos

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).
Descripción

TNM clinical staging Resectable Marginal

Tipo de datos

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,
Descripción

Disease Pathologic TNM stage

Tipo de datos

boolean

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

Stereotactic Body Radiation Therapy Clinical target volume | CT Planned

Tipo de datos

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
Descripción

ECOG performance status

Tipo de datos

boolean

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

Patient Operable

Tipo de datos

boolean

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

Exclusion Criteria

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

Patient Inoperable

Tipo de datos

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.
Descripción

Weight loss Percentage Timespan

Tipo de datos

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,
Descripción

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

Tipo de datos

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,
Descripción

Local Therapy Other Absent | Exception Disease Progression

Tipo de datos

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)
Descripción

Cancer Other Absent | Exception Skin carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
Volver a la parte superior de la página

Similar models

Eligibility Non-Small-Cell Lung Cancer NCT02433574

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial