ID

27474

Beschreibung

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

Stichworte

Versionen (1)
  1. 15.11.17 15.11.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

15. November 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Carcinoma, Non-Small-Cell Lung NCT00791336

Englisch

Eligibility Carcinoma, Non-Small-Cell Lung NCT00791336

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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
Beschreibung

Mediastinoscopy | Determination Lymph nodal status | Determination Status Resectable

Datentyp

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
Beschreibung

Biopsy Tissue specimen | Tissue Markers Determination

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Radiotherapy to thorax Excluded

Datentyp

boolean

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

Age

Datentyp

boolean

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

ECOG performance status | Karnofsky Performance Status

Datentyp

boolean

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

Organ function | Bone Marrow function

Datentyp

boolean

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

HIV Infection Absent

Datentyp

boolean

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

Pregnancy Absent

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients requiring a pneumonectomy
Beschreibung

Pneumonectomy Patient need for

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Radiotherapy to thorax

Datentyp

boolean

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

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
known metastases
Beschreibung

Neoplasm Metastasis

Datentyp

boolean

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

Allergic Reaction Compound Nelfinavir Similar

Datentyp

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.
Beschreibung

Pharmaceutical Preparations Contraindicated Nelfinavir

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

HIV Seropositivity | Anti-Retroviral Agents Combined Modality Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0599685
UMLS CUI [2,2]
C0009429
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Carcinoma, Non-Small-Cell Lung NCT00791336

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video