ID

42783

Beschrijving

Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3; ODM derived from: https://clinicaltrials.gov/show/NCT02426658

Link

https://clinicaltrials.gov/show/NCT02426658

Trefwoorden

Versies (2)
  1. 10-07-19 10-07-19 -
  2. 17-09-21 17-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 september 2021

DOI

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Creative Commons BY 4.0
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Eligibility Stage IV Non-Small Cell Lung Cancer NCT02426658

Engels

Eligibility Stage IV Non-Small Cell Lung Cancer NCT02426658

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically confirmed stage iv non-squamous histology non-small cell lung cancer
Beschrijving

Non-Squamous Non-Small Cell Lung Carcinoma TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C4324656
UMLS CUI [1,2]
C3258246
ecog performance status of 3
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
sensitizing epidermal growth factor receptor (egfr), anaplastic lymphoma receptor tyrosine kinase (alk) and ros proto-oncogene 1, receptor tyrosine kinase (ros-1) mutations are either negative or unknown
Beschrijving

EGFR gene mutation Negative | ALK gene mutation Negative | ROS1 Gene Mutation Negative | EGFR gene mutation Unknown | ALK gene mutation Unknown | ROS1 Gene Mutation Unknown

Datatype

boolean

Alias
UMLS CUI [1,1]
C3266992
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C2825843
UMLS CUI [2,2]
C1513916
UMLS CUI [3,1]
C4331213
UMLS CUI [3,2]
C1513916
UMLS CUI [4,1]
C3266992
UMLS CUI [4,2]
C0439673
UMLS CUI [5,1]
C2825843
UMLS CUI [5,2]
C0439673
UMLS CUI [6,1]
C4331213
UMLS CUI [6,2]
C0439673
absolute neutrophil count >= 1,500/mcl
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelets >= 100,000/mcl
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
creatinine clearance >= 45 ml/min
Beschrijving

Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Beschrijving

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0036899
ability to understand and the willingness to sign an institutional review board (irb)-approved informed consent document
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
ability to understand and complete the european organization for research and treatment of cancer (eortc) quality of life (qol) instruments
Beschrijving

Comprehension EORTC - Quality of life questionnaire | Completion EORTC - Quality of life questionnaire

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0451149
UMLS CUI [2,1]
C0205197
UMLS CUI [2,2]
C0451149
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have previously received chemotherapy for non-small cell lung cancer, or have received radiotherapy within 2 weeks prior to entering the study, or who have not recovered from adverse events due to treatment more than 2 weeks earlier
Beschrijving

Prior Chemotherapy Non-Small Cell Lung Carcinoma | Therapeutic radiology procedure | Adverse event Due to Therapeutic procedure | Recovery Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C2004454
UMLS CUI [4,2]
C0332268
patients whose tumors are positive for the sensitizing egfr mutation
Beschrijving

Neoplasms EGFR gene mutation Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3266992
UMLS CUI [1,3]
C1514241
patients whose tumors are positive for the sensitizing alk fusion
Beschrijving

Neoplasms ALK Fusion Protein positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2825844
patients whose tumors are positive for the sensitizing ros-1 fusion
Beschrijving

Neoplasms ROS1 Fusion Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C4331212
patients may not be receiving any other investigational agents
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
patients with symptomatic or recurrent brain metastases should be excluded from this clinical trial
Beschrijving

Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Recurrent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C2945760
history of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed
Beschrijving

Allergic Reaction Compound Pemetrexed Similar

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0210657
UMLS CUI [1,4]
C2348205
pregnant women are excluded from this study; breastfeeding should be discontinued
Beschrijving

Pregnancy | Breast Feeding To be stopped

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C1272691
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Similar models

Eligibility Stage IV Non-Small Cell Lung Cancer NCT02426658

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Squamous Non-Small Cell Lung Carcinoma TNM clinical staging
Item
patients must have histologically confirmed stage iv non-squamous histology non-small cell lung cancer
boolean
C4324656 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status of 3
boolean
C1520224 (UMLS CUI [1])
EGFR gene mutation Negative | ALK gene mutation Negative | ROS1 Gene Mutation Negative | EGFR gene mutation Unknown | ALK gene mutation Unknown | ROS1 Gene Mutation Unknown
Item
sensitizing epidermal growth factor receptor (egfr), anaplastic lymphoma receptor tyrosine kinase (alk) and ros proto-oncogene 1, receptor tyrosine kinase (ros-1) mutations are either negative or unknown
boolean
C3266992 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C2825843 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C4331213 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C3266992 (UMLS CUI [4,1])
C0439673 (UMLS CUI [4,2])
C2825843 (UMLS CUI [5,1])
C0439673 (UMLS CUI [5,2])
C4331213 (UMLS CUI [6,1])
C0439673 (UMLS CUI [6,2])
Absolute neutrophil count
Item
absolute neutrophil count >= 1,500/mcl
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets >= 100,000/mcl
boolean
C0032181 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance >= 45 ml/min
boolean
C0373595 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
Informed Consent
Item
ability to understand and the willingness to sign an institutional review board (irb)-approved informed consent document
boolean
C0021430 (UMLS CUI [1])
Comprehension EORTC - Quality of life questionnaire | Completion EORTC - Quality of life questionnaire
Item
ability to understand and complete the european organization for research and treatment of cancer (eortc) quality of life (qol) instruments
boolean
C0162340 (UMLS CUI [1,1])
C0451149 (UMLS CUI [1,2])
C0205197 (UMLS CUI [2,1])
C0451149 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Non-Small Cell Lung Carcinoma | Therapeutic radiology procedure | Adverse event Due to Therapeutic procedure | Recovery Lacking
Item
patients who have previously received chemotherapy for non-small cell lung cancer, or have received radiotherapy within 2 weeks prior to entering the study, or who have not recovered from adverse events due to treatment more than 2 weeks earlier
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C0877248 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C2004454 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Neoplasms EGFR gene mutation Positive
Item
patients whose tumors are positive for the sensitizing egfr mutation
boolean
C0027651 (UMLS CUI [1,1])
C3266992 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Neoplasms ALK Fusion Protein positive
Item
patients whose tumors are positive for the sensitizing alk fusion
boolean
C0027651 (UMLS CUI [1,1])
C2825844 (UMLS CUI [1,2])
Neoplasms ROS1 Fusion Positive
Item
patients whose tumors are positive for the sensitizing ros-1 fusion
boolean
C0027651 (UMLS CUI [1,1])
C4331212 (UMLS CUI [1,2])
Investigational New Drugs
Item
patients may not be receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Recurrent
Item
patients with symptomatic or recurrent brain metastases should be excluded from this clinical trial
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
Allergic Reaction Compound Pemetrexed Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0210657 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Pregnancy | Breast Feeding To be stopped
Item
pregnant women are excluded from this study; breastfeeding should be discontinued
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
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