ID

29322

Descrizione

The Role of Positron Emission Tomography (PET) During Erlotinib Treatment for Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01000428

collegamento

https://clinicaltrials.gov/show/NCT01000428

Keywords

versioni (1)
  1. 18/03/18 18/03/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

18 marzo 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Erlotinib NCT01000428

Inglese

Eligibility Erlotinib NCT01000428

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility Erlotinib NCT01000428
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
> 18 years of age
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
histologically documented non-small cell lung cancer with metastasis (stage iv) or locally advanced (stage iiib) with malignant effusion.
Descrizione

Non-small cell lung cancer metastatic TNM clinical staging | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Effusion, Malignant

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0278987
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [2,4]
C3258246
UMLS CUI [3]
C0080032
at least 1 measurable lesion as defined by recist. all target lesions must have a unidirectional diameter of at least 1cm. baseline measurements must be compared within 4 weeks prior to enrollment.
Descrizione

Measurable Disease Quantity | Target Lesion Diameter Size

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0456389
ecog ps 0-2
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
at least 3 weeks since the 1st line systemic therapy regimen prior to enrollment. patients must have recovered to nci ctcae v3.0 grade i from all toxicities. but 1st line erlotinib treatment is also allowed.
Descrizione

Systemic therapy First line | Toxicity CTCAE Grades Patient recovered | Erlotinib First line treatment allowed

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1708063
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1516728
UMLS CUI [2,3]
C1115804
UMLS CUI [3,1]
C1135135
UMLS CUI [3,2]
C1708063
UMLS CUI [3,3]
C0683607
at least 1 week since the last radiotherapy. patients must have recovered from all acute toxicities from radiotherapy.
Descrizione

Therapeutic radiology procedure | Toxicity Patient recovered

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1115804
patients must have adequate hematologic, renal and liver function as defined by hb > 9g/dl, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dl, and ast (sgot) and/or alt (sgpt) < 5 x unl (upper normal limit).
Descrizione

Hematologic function | Renal function | Liver function | Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0200633
UMLS CUI [6]
C0032181
UMLS CUI [7]
C0201976
UMLS CUI [8]
C0201899
UMLS CUI [9]
C0201836
willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
Descrizione

Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0525058
written and voluntary informed consent understood, signed and dated.
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior egfr tki treatment.
Descrizione

EGFR TKI Therapeutic procedure

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C1268567
UMLS CUI [1,3]
C0087111
symptomatic brain metastasis. brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
Descrizione

Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Stable | Steroid therapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205360
UMLS CUI [3]
C0149783
major surgery within 3 weeks prior to study enrollment.
Descrizione

Major surgery

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0679637
previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
Descrizione

Malignant Neoplasms | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0553723
severe medical illness or active infection that would impair the ability to receive erlotinib.
Descrizione

Severe disorder Impairment Receive Erlotinib | Communicable Disease Impairment Receive Erlotinib

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1836348
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C1514756
UMLS CUI [1,4]
C1135135
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C1514756
UMLS CUI [2,4]
C1135135
pregnancy or breast feeding.
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Ritorna all'inizio della pagina

Similar models

Eligibility Erlotinib NCT01000428

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility Erlotinib NCT01000428
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
> 18 years of age
boolean
C0001779 (UMLS CUI [1])
Non-small cell lung cancer metastatic TNM clinical staging | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Effusion, Malignant
Item
histologically documented non-small cell lung cancer with metastasis (stage iv) or locally advanced (stage iiib) with malignant effusion.
boolean
C0278987 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C0080032 (UMLS CUI [3])
Measurable Disease Quantity | Target Lesion Diameter Size
Item
at least 1 measurable lesion as defined by recist. all target lesions must have a unidirectional diameter of at least 1cm. baseline measurements must be compared within 4 weeks prior to enrollment.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2986546 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
ECOG performance status
Item
ecog ps 0-2
boolean
C1520224 (UMLS CUI [1])
Systemic therapy First line | Toxicity CTCAE Grades Patient recovered | Erlotinib First line treatment allowed
Item
at least 3 weeks since the 1st line systemic therapy regimen prior to enrollment. patients must have recovered to nci ctcae v3.0 grade i from all toxicities. but 1st line erlotinib treatment is also allowed.
boolean
C1515119 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1115804 (UMLS CUI [2,3])
C1135135 (UMLS CUI [3,1])
C1708063 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Therapeutic radiology procedure | Toxicity Patient recovered
Item
at least 1 week since the last radiotherapy. patients must have recovered from all acute toxicities from radiotherapy.
boolean
C1522449 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
Hematologic function | Renal function | Liver function | Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
patients must have adequate hematologic, renal and liver function as defined by hb > 9g/dl, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dl, and ast (sgot) and/or alt (sgpt) < 5 x unl (upper normal limit).
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
Protocol Compliance
Item
willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
written and voluntary informed consent understood, signed and dated.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
EGFR TKI Therapeutic procedure
Item
prior egfr tki treatment.
boolean
C0034802 (UMLS CUI [1,1])
C1268567 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Stable | Steroid therapy
Item
symptomatic brain metastasis. brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0149783 (UMLS CUI [3])
Major surgery
Item
major surgery within 3 weeks prior to study enrollment.
boolean
C0679637 (UMLS CUI [1])
Malignant Neoplasms | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin
Item
previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0553723 (UMLS CUI [4,3])
Severe disorder Impairment Receive Erlotinib | Communicable Disease Impairment Receive Erlotinib
Item
severe medical illness or active infection that would impair the ability to receive erlotinib.
boolean
C1836348 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C1135135 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C1514756 (UMLS CUI [2,3])
C1135135 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial