ID

32569

Descrição

To Evaluate Postoperative 3D Conform Radiotherapy in Patients With IIIA (N2) Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00880971

Link

https://clinicaltrials.gov/show/NCT00880971

Palavras-chave

Versões (1)
  1. 06/11/2018 06/11/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de novembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Thoracic Neoplasms NCT00880971

Inglês

Eligibility Thoracic Neoplasms NCT00880971

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
completely resected disease by lobectomy, bilobectomy. complete dissection of lymph nodes at levels 4, 7, and 10 in case of right-sided thoracotomy and at levels 4 (if accessible), 5, 6, 7, and 10 in case of left-sided thoracotomy.
Descrição

Disease Complete excision | Lobectomy | Bilobectomy | Lymph Node Dissection Complete Level | Thoracotomy Sidedness

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0015250
UMLS CUI [2]
C0023928
UMLS CUI [3]
C3248080
UMLS CUI [4,1]
C0242382
UMLS CUI [4,2]
C0205197
UMLS CUI [4,3]
C0441889
UMLS CUI [5,1]
C0039991
UMLS CUI [5,2]
C0457012
histologically n2 disease after surgery. negative margins and no extracapsular extension in a node
Descrição

Disease Postoperative TNM clinical staging | Negative Surgical Margins | Absence Extension Extracapsular Lymph node

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0032790
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C1709157
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0231448
UMLS CUI [3,3]
C1517049
UMLS CUI [3,4]
C0024204
has undergone chemotherapy of four cycles of np regimen and no recurrence and metastasis
Descrição

Chemotherapy cycle Quantity Cisplatin-Vinorelbine Regimen | Recurrence Absent | Neoplasm Metastasis Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1882260
UMLS CUI [2,1]
C0034897
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
ecog performance status > 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
post-operative fev_1 < 1 l (or < 35% theoretical value, po_2 < 70 mm hg, and pco_2 > 45 mm hg)
Descrição

FEV1 Postoperative | PO2 measurement Postoperative | PCO2 Postoperative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0849974
UMLS CUI [1,2]
C0032790
UMLS CUI [2,1]
C1283004
UMLS CUI [2,2]
C0032790
UMLS CUI [3,1]
C0201931
UMLS CUI [3,2]
C0032790
severe cardiac disease within the past 6 months, including the following: arrhythmia, congestive heart failure, infarction, pacemaker
Descrição

Heart Disease Severe | Cardiac Arrhythmia | Congestive heart failure | Infarction | Artificial cardiac pacemaker

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0021308
UMLS CUI [5]
C0030163
severe pulmonary disease within the past 6 months
Descrição

Lung disease Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
other prior or concurrent neoplasm, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
Descrição

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
severe or uncontrolled systemic disease
Descrição

Systemic disease Severe | Systemic disease Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
familial, social, geographic, or psychological conditions that would preclude study participation
Descrição

Condition Familial Study Subject Participation Status Excluded | Social Condition Study Subject Participation Status Excluded | Geographic Factors Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0241888
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0332196
UMLS CUI [2,1]
C0037403
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C0017444
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C0332196
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Similar models

Eligibility Thoracic Neoplasms NCT00880971

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Disease Complete excision | Lobectomy | Bilobectomy | Lymph Node Dissection Complete Level | Thoracotomy Sidedness
Item
completely resected disease by lobectomy, bilobectomy. complete dissection of lymph nodes at levels 4, 7, and 10 in case of right-sided thoracotomy and at levels 4 (if accessible), 5, 6, 7, and 10 in case of left-sided thoracotomy.
boolean
C0012634 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
C0023928 (UMLS CUI [2])
C3248080 (UMLS CUI [3])
C0242382 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0441889 (UMLS CUI [4,3])
C0039991 (UMLS CUI [5,1])
C0457012 (UMLS CUI [5,2])
Disease Postoperative TNM clinical staging | Negative Surgical Margins | Absence Extension Extracapsular Lymph node
Item
histologically n2 disease after surgery. negative margins and no extracapsular extension in a node
boolean
C0012634 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1709157 (UMLS CUI [2])
C0332197 (UMLS CUI [3,1])
C0231448 (UMLS CUI [3,2])
C1517049 (UMLS CUI [3,3])
C0024204 (UMLS CUI [3,4])
Chemotherapy cycle Quantity Cisplatin-Vinorelbine Regimen | Recurrence Absent | Neoplasm Metastasis Absent
Item
has undergone chemotherapy of four cycles of np regimen and no recurrence and metastasis
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1882260 (UMLS CUI [1,3])
C0034897 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status > 1
boolean
C1520224 (UMLS CUI [1])
FEV1 Postoperative | PO2 measurement Postoperative | PCO2 Postoperative
Item
post-operative fev_1 < 1 l (or < 35% theoretical value, po_2 < 70 mm hg, and pco_2 > 45 mm hg)
boolean
C0849974 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C1283004 (UMLS CUI [2,1])
C0032790 (UMLS CUI [2,2])
C0201931 (UMLS CUI [3,1])
C0032790 (UMLS CUI [3,2])
Heart Disease Severe | Cardiac Arrhythmia | Congestive heart failure | Infarction | Artificial cardiac pacemaker
Item
severe cardiac disease within the past 6 months, including the following: arrhythmia, congestive heart failure, infarction, pacemaker
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0021308 (UMLS CUI [4])
C0030163 (UMLS CUI [5])
Lung disease Severe
Item
severe pulmonary disease within the past 6 months
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
other prior or concurrent neoplasm, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Systemic disease Severe | Systemic disease Uncontrolled
Item
severe or uncontrolled systemic disease
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Condition Familial Study Subject Participation Status Excluded | Social Condition Study Subject Participation Status Excluded | Geographic Factors Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded
Item
familial, social, geographic, or psychological conditions that would preclude study participation
boolean
C0348080 (UMLS CUI [1,1])
C0241888 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0332196 (UMLS CUI [1,4])
C0037403 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0017444 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
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