ID

22340

Descripción

Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00314873

Link

https://clinicaltrials.gov/show/NCT00314873

Palabras clave

Versiones (1)
  1. 30/5/17 30/5/17 -
Subido en

30 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Thymic Carcinoma NCT00314873

Inglés

Eligibility Thymic Carcinoma NCT00314873

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological proof of advanced c-kit positive or pdgfr positive thymic carcinoma. for protocol purposes, advanced disease is defined as disease
Descripción

c-kit and pdgfr positive thymic carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205969
UMLS CUI [1,2]
C0072470
UMLS CUI [1,3]
C0071253
patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy.
Descripción

measuable thymic carcinoma lesion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205969
UMLS CUI [1,2]
C1513041
no prior imatinib therapy.
Descripción

imatinib

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0935989
age > 18 years at the time of consent
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0 or 1
Descripción

ecog

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
anc ≥ 1500/mm3,platelet count ≥ 100,000/mm,total bilirubin < 1.5uln,3.10 serum creatinine ≤ 1.7 mg/dl,alt and ast ≤ 3 x uln
Descripción

anc, platelet count, total bilirubin, serum creatinine, alt, ast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0201913
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant infections as judged by the treating investigator
Descripción

infections

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
clinically significant concurrent illnesses
Descripción

comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
females of childbearing potential not using birth control or breastfeeding
Descripción

females of childbearing potential birth control, breastfeeding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0006147
prior radiation therapy > 25% of the bone marrow
Descripción

bone marrow radiation therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
symptomatic brain metastasis
Descripción

symptomatic brain metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
history of grade iii/iv cardiac problems
Descripción

cardiac problems

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262402
history of major surgery within 14 days prior to being registered
Descripción

major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
Descripción

investigational agent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Thymic Carcinoma NCT00314873

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
c-kit and pdgfr positive thymic carcinoma
Item
histological or cytological proof of advanced c-kit positive or pdgfr positive thymic carcinoma. for protocol purposes, advanced disease is defined as disease
boolean
C0205969 (UMLS CUI [1,1])
C0072470 (UMLS CUI [1,2])
C0071253 (UMLS CUI [1,3])
measuable thymic carcinoma lesion
Item
patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy.
boolean
C0205969 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
imatinib
Item
no prior imatinib therapy.
boolean
C0935989 (UMLS CUI [1])
age
Item
age > 18 years at the time of consent
boolean
C0001779 (UMLS CUI [1])
ecog
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
anc, platelet count, total bilirubin, serum creatinine, alt, ast
Item
anc ≥ 1500/mm3,platelet count ≥ 100,000/mm,total bilirubin < 1.5uln,3.10 serum creatinine ≤ 1.7 mg/dl,alt and ast ≤ 3 x uln
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0201913 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
infections
Item
clinically significant infections as judged by the treating investigator
boolean
C0009450 (UMLS CUI [1])
comorbidity
Item
clinically significant concurrent illnesses
boolean
C0009488 (UMLS CUI [1])
females of childbearing potential birth control, breastfeeding
Item
females of childbearing potential not using birth control or breastfeeding
boolean
C1960468 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
bone marrow radiation therapy
Item
prior radiation therapy > 25% of the bone marrow
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
symptomatic brain metastasis
Item
symptomatic brain metastasis
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
cardiac problems
Item
history of grade iii/iv cardiac problems
boolean
C0262402 (UMLS CUI [1])
major surgery
Item
history of major surgery within 14 days prior to being registered
boolean
C0679637 (UMLS CUI [1])
investigational agent
Item
treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
boolean
C0013230 (UMLS CUI [1])
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