ID

36606

Beskrivning

Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02064491

Länk

https://clinicaltrials.gov/show/NCT02064491

Nyckelord

Versioner (1)
  1. 2019-05-26 2019-05-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 maj 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Non-small Cell Lung Cancer NCT02064491

Engelsk

Eligibility Non-small Cell Lung Cancer NCT02064491

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed stage iiib/iv nsclc.
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
investigator confirmed progression according recist 1.1 during egfr tki treatment within 28 days of the randomization
Beskrivning

Disease Progression Timespan | EGFR Tyrosine Kinase inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0872291
UMLS CUI [2]
C1443775
activating mutation (g719a/c/s; exon 19 insertion/deletion; l858r; l861q) in the egfr gene or have had at least partial response with egfr tki lasting ≥ 6 months
Beskrivning

EGFR Activating Mutation | EGFR G719A | EGFR G719C | EGFR G719S | EGFR Exon 19 Insertion | EGFR exon 19 deletion | EGFR L858R | EGFR L861Q | Partial response EGFR Tyrosine Kinase inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C2984891
UMLS CUI [2]
C3274209
UMLS CUI [3]
C3274211
UMLS CUI [4]
C3274216
UMLS CUI [5]
C4525161
UMLS CUI [6]
C3889117
UMLS CUI [7]
C3274204
UMLS CUI [8]
C3274186
UMLS CUI [9,1]
C1521726
UMLS CUI [9,2]
C1443775
performance status: who 0-2
Beskrivning

Performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1518965
measurable disease according to recist 1.1
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
patients must be able to comply with study treatments
Beskrivning

Compliance behavior Investigational Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0949266
women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
Beskrivning

Females & males of reproductive potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
neutrophils ≥ 1'000/μl, platelets ≥ 100'000/μl, alanine amino transferase ≤ 2.5 ×
Beskrivning

Neutrophil count | Platelet Count measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Datatyp

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0494165
upper limit of normal (uln) (< 5 × uln if liver metastases), alkaline phosphatase ≤
Beskrivning

Alkaline phosphatase measurement | Secondary malignant neoplasm of liver

Datatyp

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0494165
2.5 × uln (< 5 × uln if liver metastases), serum bilirubin ≤ 1.5 × uln, serum creatinine ≤ 1.5 × uln.
Beskrivning

Serum total bilirubin measurement | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201976
patient must be able to comply with the protocol
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
recist 1.1 defined disease progression for more than 28 days while on previous egfr tki treatment.
Beskrivning

Disease Progression Timespan | EGFR Tyrosine Kinase inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0872291
UMLS CUI [2]
C1443775
patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
patient has history of hypersensitivity or intolerance to erlotinib or gefitinib.
Beskrivning

Hypersensitivity Erlotinib | Intolerance to Erlotinib | Hypersensitivity Gefitinib | Intolerance to Gefitinib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1135135
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1135135
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1122962
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C1122962
patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study.
Beskrivning

Hypersensitivity Antineoplastic Agents | Intolerance to Antineoplastic Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003392
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0003392
patient with symptomatic central nervous system metastases
Beskrivning

CNS metastases Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
patient has known active hepatitis b or c, or hiv infection
Beskrivning

Hepatitis B | Hepatitis C | HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
pregnant or breastfeeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
Beskrivning

Comorbidity Uncontrolled Limiting Protocol Compliance | Circumstances Limiting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0680082
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
Tillbaka till toppen

Similar models

Eligibility Non-small Cell Lung Cancer NCT02064491

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically confirmed stage iiib/iv nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Disease Progression Timespan | EGFR Tyrosine Kinase inhibitors
Item
investigator confirmed progression according recist 1.1 during egfr tki treatment within 28 days of the randomization
boolean
C0242656 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
C1443775 (UMLS CUI [2])
EGFR Activating Mutation | EGFR G719A | EGFR G719C | EGFR G719S | EGFR Exon 19 Insertion | EGFR exon 19 deletion | EGFR L858R | EGFR L861Q | Partial response EGFR Tyrosine Kinase inhibitors
Item
activating mutation (g719a/c/s; exon 19 insertion/deletion; l858r; l861q) in the egfr gene or have had at least partial response with egfr tki lasting ≥ 6 months
boolean
C2984891 (UMLS CUI [1])
C3274209 (UMLS CUI [2])
C3274211 (UMLS CUI [3])
C3274216 (UMLS CUI [4])
C4525161 (UMLS CUI [5])
C3889117 (UMLS CUI [6])
C3274204 (UMLS CUI [7])
C3274186 (UMLS CUI [8])
C1521726 (UMLS CUI [9,1])
C1443775 (UMLS CUI [9,2])
Performance status
Item
performance status: who 0-2
boolean
C1518965 (UMLS CUI [1])
Measurable Disease
Item
measurable disease according to recist 1.1
boolean
C1513041 (UMLS CUI [1])
Compliance behavior Investigational Therapy
Item
patients must be able to comply with study treatments
boolean
C1321605 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
Females & males of reproductive potential Contraceptive methods
Item
women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Neutrophil count | Platelet Count measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
neutrophils ≥ 1'000/μl, platelets ≥ 100'000/μl, alanine amino transferase ≤ 2.5 ×
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0494165 (UMLS CUI [4])
Alkaline phosphatase measurement | Secondary malignant neoplasm of liver
Item
upper limit of normal (uln) (< 5 × uln if liver metastases), alkaline phosphatase ≤
boolean
C0201850 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
Serum total bilirubin measurement | Creatinine measurement, serum
Item
2.5 × uln (< 5 × uln if liver metastases), serum bilirubin ≤ 1.5 × uln, serum creatinine ≤ 1.5 × uln.
boolean
C1278039 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Protocol Compliance
Item
patient must be able to comply with the protocol
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Progression Timespan | EGFR Tyrosine Kinase inhibitors
Item
recist 1.1 defined disease progression for more than 28 days while on previous egfr tki treatment.
boolean
C0242656 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
C1443775 (UMLS CUI [2])
Investigational New Drugs
Item
patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Erlotinib | Intolerance to Erlotinib | Hypersensitivity Gefitinib | Intolerance to Gefitinib
Item
patient has history of hypersensitivity or intolerance to erlotinib or gefitinib.
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1135135 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1122962 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C1122962 (UMLS CUI [4,2])
Hypersensitivity Antineoplastic Agents | Intolerance to Antineoplastic Agents
Item
patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study.
boolean
C0020517 (UMLS CUI [1,1])
C0003392 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0003392 (UMLS CUI [2,2])
CNS metastases Symptomatic
Item
patient with symptomatic central nervous system metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Hepatitis B | Hepatitis C | HIV Infection
Item
patient has known active hepatitis b or c, or hiv infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Uncontrolled Limiting Protocol Compliance | Circumstances Limiting Protocol Compliance
Item
patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0680082 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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