ID

14960

Beschrijving

A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase; ODM derived from: https://clinicaltrials.gov/show/NCT00528281

Link

https://clinicaltrials.gov/show/NCT00528281

Trefwoorden

  1. 09-05-16 09-05-16 -
Geüploaded op

9 mei 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Advanced Non-Small Cell Lung Cancer NCT00528281

Eligibility Advanced Non-Small Cell Lung Cancer NCT00528281

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
Written informed consent
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients must be 18 years old
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
subjects must have stage iiib or iv nsclc
Beschrijving

nsclc

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
recurrent or persistent nsclc following one previous line of cytotoxic chemotherapy
Beschrijving

cytotoxic chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0677881
eastern cooperative oncology group (ecog) performance status (ps) 0-2;
Beschrijving

ecog

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of 12 weeks
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
have adequate organ function baseline laboratory values for inclusion
Beschrijving

organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of other malignancy. subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;
Beschrijving

malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0455471
known history of or clinical evidence of central nervous system (cns) metastases or leptomeningeal carcinomatosis except for individuals who have previously treated cns metastases, are asymptomatic, and have had no requirement for steroids or antiseizure medication for = 3 months prior to study enrollment.
Beschrijving

central nervous system metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
peripheral neuropathy of grade 3 or higher
Beschrijving

peripheral neuropathy

Datatype

boolean

Alias
UMLS CUI [1]
C0031117
concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).
Beschrijving

cconcurrent ancer therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C0920425
prior exposure to pemetrexed or an egfr inhibitor in combination with 5-fu or a 5fu prodrug.
Beschrijving

pemetrexed

Datatype

boolean

Alias
UMLS CUI [1]
C0210657

Similar models

Eligibility Advanced Non-Small Cell Lung Cancer NCT00528281

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI [1])
age
Item
patients must be 18 years old
boolean
C0001779 (UMLS CUI [1])
nsclc
Item
subjects must have stage iiib or iv nsclc
boolean
C0007131 (UMLS CUI [1])
cytotoxic chemotherapy
Item
recurrent or persistent nsclc following one previous line of cytotoxic chemotherapy
boolean
C0677881 (UMLS CUI [1])
ecog
Item
eastern cooperative oncology group (ecog) performance status (ps) 0-2;
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
life expectancy of 12 weeks
boolean
C0023671 (UMLS CUI [1])
organ function
Item
have adequate organ function baseline laboratory values for inclusion
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
malignancy
Item
history of other malignancy. subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;
boolean
C0455471 (UMLS CUI [1])
central nervous system metastases
Item
known history of or clinical evidence of central nervous system (cns) metastases or leptomeningeal carcinomatosis except for individuals who have previously treated cns metastases, are asymptomatic, and have had no requirement for steroids or antiseizure medication for = 3 months prior to study enrollment.
boolean
C0686377 (UMLS CUI [1])
peripheral neuropathy
Item
peripheral neuropathy of grade 3 or higher
boolean
C0031117 (UMLS CUI [1])
cconcurrent ancer therapy
Item
concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).
boolean
C0205420 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
pemetrexed
Item
prior exposure to pemetrexed or an egfr inhibitor in combination with 5-fu or a 5fu prodrug.
boolean
C0210657 (UMLS CUI [1])

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