ID

27474

Description

Study to Evaluate Using Nelfinavir With Chemoradiation for Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00791336

Link

https://clinicaltrials.gov/show/NCT00791336

Keywords

Versions (1)
  1. 11/15/17 11/15/17 -
Copyright Holder

See clinicaltrials.gov

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November 15, 2017

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00791336

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT00791336

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological diagnosis of non-small cell lung cancer that is stage iii (t1-3, pn2, m0) nsclc in whom neoadjuvant therapy is recommended.
Description

Non-Small Cell Lung Carcinoma TNM clinical staging | Neoadjuvant Therapy Recommended

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0034866
must have had a mediastinoscopy to determine nodal status and potential resectability
Description

Mediastinoscopy | Determination Lymph nodal status | Determination Status Resectable

Data type

boolean

Alias
UMLS CUI [1]
C0025065
UMLS CUI [2,1]
C1148554
UMLS CUI [2,2]
C0449927
UMLS CUI [3,1]
C1148554
UMLS CUI [3,2]
C0449438
UMLS CUI [3,3]
C1514888
must have enough tissue from the biopsy for tissue marker determination for correlative studies
Description

Biopsy Tissue specimen | Tissue Markers Determination

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1292533
UMLS CUI [2,1]
C0183956
UMLS CUI [2,2]
C1148554
negative metastatic work up (fdg pet/ct, brain ct or mri)
Description

Work up metastatic negative | Fluorodeoxyglucose F18 PET/CT | CT brain | MRI brain

Data type

boolean

Alias
UMLS CUI [1,1]
C0750430
UMLS CUI [1,2]
C1522484
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C0046056
UMLS CUI [2,2]
C1699633
UMLS CUI [3]
C0412585
UMLS CUI [4]
C0412675
no prior thoracic radiotherapy will be permitted
Description

Radiotherapy to thorax Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C4038705
UMLS CUI [1,2]
C2828389
age 18 years or greater
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0-1 (karnofsky at least 70%)
Description

ECOG performance status | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
normal organ and marrow function
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
no known hiv infection
Description

HIV Infection Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0332197
not pregnant
Description

Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
ability to understand and the willingness to sign an informed consent document
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients requiring a pneumonectomy
Description

Pneumonectomy Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0032284
UMLS CUI [1,2]
C0686904
patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study, or who have not recovered from adverse events due to agents administered earlier.
Description

Chemotherapy | Therapeutic radiology procedure | Adverse event Due to Pharmaceutical Preparations Previous | Recovery Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0013227
UMLS CUI [3,4]
C0205156
UMLS CUI [4,1]
C2004454
UMLS CUI [4,2]
C0332268
prior thoracic radiation
Description

Radiotherapy to thorax

Data type

boolean

Alias
UMLS CUI [1]
C4038705
treatment with any other investigational agents.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
known metastases
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
history of allergic reactions attributed to compounds of similar chemical or biologic composition to nfv
Description

Allergic Reaction Compound Nelfinavir Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0525005
UMLS CUI [1,4]
C2348205
patients receiving drugs contraindicated with nfv will be excluded.
Description

Pharmaceutical Preparations Contraindicated Nelfinavir

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C0525005
uncontrolled, intercurrent 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 compliance.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
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
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
hiv-positive patients on combination antiretroviral therapy
Description

HIV Seropositivity | Anti-Retroviral Agents Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0599685
UMLS CUI [2,2]
C0009429
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00791336

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Neoadjuvant Therapy Recommended
Item
histological diagnosis of non-small cell lung cancer that is stage iii (t1-3, pn2, m0) nsclc in whom neoadjuvant therapy is recommended.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2,1])
C0034866 (UMLS CUI [2,2])
Mediastinoscopy | Determination Lymph nodal status | Determination Status Resectable
Item
must have had a mediastinoscopy to determine nodal status and potential resectability
boolean
C0025065 (UMLS CUI [1])
C1148554 (UMLS CUI [2,1])
C0449927 (UMLS CUI [2,2])
C1148554 (UMLS CUI [3,1])
C0449438 (UMLS CUI [3,2])
C1514888 (UMLS CUI [3,3])
Biopsy Tissue specimen | Tissue Markers Determination
Item
must have enough tissue from the biopsy for tissue marker determination for correlative studies
boolean
C0005558 (UMLS CUI [1,1])
C1292533 (UMLS CUI [1,2])
C0183956 (UMLS CUI [2,1])
C1148554 (UMLS CUI [2,2])
Work up metastatic negative | Fluorodeoxyglucose F18 PET/CT | CT brain | MRI brain
Item
negative metastatic work up (fdg pet/ct, brain ct or mri)
boolean
C0750430 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0046056 (UMLS CUI [2,1])
C1699633 (UMLS CUI [2,2])
C0412585 (UMLS CUI [3])
C0412675 (UMLS CUI [4])
Radiotherapy to thorax Excluded
Item
no prior thoracic radiotherapy will be permitted
boolean
C4038705 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Age
Item
age 18 years or greater
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
ecog performance status 0-1 (karnofsky at least 70%)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Organ function | Bone Marrow function
Item
normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
HIV Infection Absent
Item
no known hiv infection
boolean
C0019693 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Pregnancy Absent
Item
not pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and the willingness to sign an informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pneumonectomy Patient need for
Item
patients requiring a pneumonectomy
boolean
C0032284 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Chemotherapy | Therapeutic radiology procedure | Adverse event Due to Pharmaceutical Preparations Previous | Recovery Lacking
Item
patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study, or who have not recovered from adverse events due to agents administered earlier.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0877248 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0205156 (UMLS CUI [3,4])
C2004454 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Radiotherapy to thorax
Item
prior thoracic radiation
boolean
C4038705 (UMLS CUI [1])
Investigational New Drugs
Item
treatment with any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Neoplasm Metastasis
Item
known metastases
boolean
C0027627 (UMLS CUI [1])
Allergic Reaction Compound Nelfinavir Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to nfv
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0525005 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Pharmaceutical Preparations Contraindicated Nelfinavir
Item
patients receiving drugs contraindicated with nfv will be excluded.
boolean
C0013227 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0525005 (UMLS CUI [1,3])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
uncontrolled, intercurrent 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 compliance.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
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])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity | Anti-Retroviral Agents Combined Modality Therapy
Item
hiv-positive patients on combination antiretroviral therapy
boolean
C0019699 (UMLS CUI [1])
C0599685 (UMLS CUI [2,1])
C0009429 (UMLS CUI [2,2])
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