ID

37240

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02426658

Nyckelord

Versioner (2)
  1. 2019-07-10 2019-07-10 -
  2. 2021-09-17 2021-09-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 juli 2019

DOI

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Licens

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

Engelsk

Eligibility Stage IV Non-Small Cell Lung Cancer NCT02426658

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4528750
UMLS CUI [1,2]
C3258246
ecog performance status of 3
Beskrivning

ECOG performance status

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Absolute neutrophil count

Datatyp

boolean

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

Platelet Count measurement

Datatyp

boolean

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

Creatinine clearance measurement

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Informed Consent

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

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
Beskrivning

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

Datatyp

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
Beskrivning

Neoplasms EGFR gene mutation Positive

Datatyp

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
Beskrivning

Neoplasms ALK Fusion Protein positive

Datatyp

boolean

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

Neoplasms ROS1 Fusion Positive

Datatyp

boolean

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

Investigational New Drugs

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Allergic Reaction Compound Pemetrexed Similar

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding To be stopped

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
C4528750 (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])
Tillbaka till toppen 

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