ID

33930

Beskrivning

A Phase II Study of Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02328261

Länk

https://clinicaltrials.gov/show/NCT02328261

Nyckelord

  1. 2019-01-08 2019-01-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 januari 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.

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 Nasopharyngeal Carcinoma NCT02328261

Eligibility Nasopharyngeal Carcinoma NCT02328261

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed advanced npc
Beskrivning

Nasopharyngeal carcinoma Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C0205179
patients must be platinum-resistant defined as recurrence or progression of disease <6 months since previous treatment with a platinum based treatment regimen.
Beskrivning

Platinum Resistant | Recurrent disease | Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032207
UMLS CUI [1,2]
C0332325
UMLS CUI [2]
C0277556
UMLS CUI [3]
C0242656
measurable disease per recist
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
adequate organ and marrow function
Beskrivning

Organ function | Bone Marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
capable of understanding and complying with the protocol, and written informed consent
Beskrivning

Protocol Compliance | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with gefitinib, erlotinib, or other drugs that target egfr
Beskrivning

gefitinib | erlotinib | Pharmaceutical Preparations Targeting Epidermal Growth Factor Receptor

Datatyp

boolean

Alias
UMLS CUI [1]
C1122962
UMLS CUI [2]
C1135135
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0034802
patients must not be receiving any other investigational agents
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection
Beskrivning

Illness Serious Treatment required for | Medical condition Treatment required for | Heart Diseases Unstable | Nervous system disorder | Mental disorders | Psychotic Disorders | Dementia | Seizures | Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332121
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0004936
UMLS CUI [6]
C0033975
UMLS CUI [7]
C0497327
UMLS CUI [8]
C0036572
UMLS CUI [9,1]
C0009450
UMLS CUI [9,2]
C0205318
women who are pregnant or breast-feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Nasopharyngeal Carcinoma NCT02328261

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal carcinoma Advanced
Item
histologically confirmed advanced npc
boolean
C2931822 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Platinum Resistant | Recurrent disease | Disease Progression
Item
patients must be platinum-resistant defined as recurrence or progression of disease <6 months since previous treatment with a platinum based treatment regimen.
boolean
C0032207 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
Measurable Disease
Item
measurable disease per recist
boolean
C1513041 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
adequate organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Protocol Compliance | Informed Consent
Item
capable of understanding and complying with the protocol, and written informed consent
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
gefitinib | erlotinib | Pharmaceutical Preparations Targeting Epidermal Growth Factor Receptor
Item
prior treatment with gefitinib, erlotinib, or other drugs that target egfr
boolean
C1122962 (UMLS CUI [1])
C1135135 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0034802 (UMLS CUI [3,3])
Investigational New Drugs
Item
patients must not be receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Illness Serious Treatment required for | Medical condition Treatment required for | Heart Diseases Unstable | Nervous system disorder | Mental disorders | Psychotic Disorders | Dementia | Seizures | Communicable Disease Uncontrolled
Item
other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
C0033975 (UMLS CUI [6])
C0497327 (UMLS CUI [7])
C0036572 (UMLS CUI [8])
C0009450 (UMLS CUI [9,1])
C0205318 (UMLS CUI [9,2])
Pregnancy | Breast Feeding
Item
women who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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

Fält markerade med * är obligatoriska.

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