ID

21467

Descripción

Trial of RAD001 in Patients With Operable Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00401778

Link

https://clinicaltrials.gov/show/NCT00401778

Palabras clave

Versiones (1)
  1. 22/4/17 22/4/17 -
Subido en

22 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00401778

Inglés

Eligibility Lung Cancer NCT00401778

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must have histologically confirmed stage i-iiia non-small cell lung cancer (nsclc) which is accessible to biopsy.
Descripción

Non-Small Cell Lung Carcinoma TNM clinical staging | Disease Amenable Biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0005558
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
life-expectancy greater than 6 months.
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
adequate bone marrow, renal, hepatic, pulmonary and cardiac function as defined in the protocol.
Descripción

Bone Marrow function | Renal function | Liver function | Pulmonary function | Cardiac function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0231921
UMLS CUI [5]
C0232164
patient must be at least 18 years of age.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
must meet pre-entry requirements for timing of study parameters as specified in section 7.0.
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
female patients of child-bearing potential must have a negative serum pregnancy test within 48 hours of study initiation and be non-lactating.
Descripción

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0006147
UMLS CUI [2,3]
C0332197
patients of child-bearing potential must agree to use an effective form of contraception while on study and for 3 months following completion of study treatment.
Descripción

Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
the use of granulocyte-colony stimulating factor (g-csf) will be permitted in study participants.
Descripción

Granulocyte Colony-Stimulating Factor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079459
final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Descripción

Eligibility Determination Medical research personnel

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C3826005
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has received previous treatment for nsclc.
Descripción

Therapeutic procedure Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0007131
known hypersensitivity to everolimus, sirolimus, or any of its excipients.
Descripción

Hypersensitivity everolimus | Hypersensitivity Sirolimus | Hypersensitivity everolimus Excipient | Hypersensitivity Sirolimus Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0541315
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0072980
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0541315
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0072980
UMLS CUI [4,3]
C0015237
patient is pregnant or breast-feeding.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient has incurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Descripción

Comorbidity | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0439801
patient is unable to swallow rad001 tablet.
Descripción

Able to swallow RAD 001 Tablet

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0962969
UMLS CUI [1,3]
C0039225
history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of the malignancy being present within the past five years.
Descripción

invasive cancer | Skin carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0699893
history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. symptoms may include any reaction such as bronchospasm, generalized urticaria, systolic bp ≤ 80mm hg, and angioedema.
Descripción

Severe allergy docetaxel | Severe allergy Polysorbate 80 Pharmaceutical Preparations | Bronchial Spasm | Generalized urticaria | Systolic Pressure | Angioedema

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0032601
UMLS CUI [2,3]
C0013227
UMLS CUI [3]
C0006266
UMLS CUI [4]
C0750016
UMLS CUI [5]
C0871470
UMLS CUI [6]
C0002994
final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Descripción

Eligibility Determination Medical research personnel

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C3826005
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Similar models

Eligibility Lung Cancer NCT00401778

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Disease Amenable Biopsy
Item
patient must have histologically confirmed stage i-iiia non-small cell lung cancer (nsclc) which is accessible to biopsy.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life-expectancy greater than 6 months.
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function | Renal function | Liver function | Pulmonary function | Cardiac function
Item
adequate bone marrow, renal, hepatic, pulmonary and cardiac function as defined in the protocol.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0231921 (UMLS CUI [4])
C0232164 (UMLS CUI [5])
Age
Item
patient must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
must meet pre-entry requirements for timing of study parameters as specified in section 7.0.
boolean
C0525058 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Breast Feeding Absent
Item
female patients of child-bearing potential must have a negative serum pregnancy test within 48 hours of study initiation and be non-lactating.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods
Item
patients of child-bearing potential must agree to use an effective form of contraception while on study and for 3 months following completion of study treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Granulocyte Colony-Stimulating Factor
Item
the use of granulocyte-colony stimulating factor (g-csf) will be permitted in study participants.
boolean
C0079459 (UMLS CUI [1])
Eligibility Determination Medical research personnel
Item
final eligibility for a clinical trial is determined by the health professionals conducting the trial.
boolean
C0013893 (UMLS CUI [1,1])
C3826005 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Non-Small Cell Lung Carcinoma
Item
patient has received previous treatment for nsclc.
boolean
C0087111 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
Hypersensitivity everolimus | Hypersensitivity Sirolimus | Hypersensitivity everolimus Excipient | Hypersensitivity Sirolimus Excipient
Item
known hypersensitivity to everolimus, sirolimus, or any of its excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0541315 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0541315 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0072980 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
patient is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
patient has incurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Able to swallow RAD 001 Tablet
Item
patient is unable to swallow rad001 tablet.
boolean
C2712086 (UMLS CUI [1,1])
C0962969 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
invasive cancer | Skin carcinoma
Item
history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of the malignancy being present within the past five years.
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
Severe allergy docetaxel | Severe allergy Polysorbate 80 Pharmaceutical Preparations | Bronchial Spasm | Generalized urticaria | Systolic Pressure | Angioedema
Item
history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. symptoms may include any reaction such as bronchospasm, generalized urticaria, systolic bp ≤ 80mm hg, and angioedema.
boolean
C2945656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C0006266 (UMLS CUI [3])
C0750016 (UMLS CUI [4])
C0871470 (UMLS CUI [5])
C0002994 (UMLS CUI [6])
Eligibility Determination Medical research personnel
Item
final eligibility for a clinical trial is determined by the health professionals conducting the trial.
boolean
C0013893 (UMLS CUI [1,1])
C3826005 (UMLS CUI [1,2])
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