ID

31156

Beskrivning

A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib); ODM derived from: https://clinicaltrials.gov/show/NCT00854308

Länk

https://clinicaltrials.gov/show/NCT00854308

Nyckelord

Versioner (1)
  1. 2018-07-23 2018-07-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 juli 2018

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 NCT00854308

Engelsk

Eligibility Non-Small Cell Lung Cancer NCT00854308

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must meet the following criteria for study entry:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
histologically confirmed nsclc
Beskrivning

Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
availability of a tumor specimen
Beskrivning

Availability of Tumor tissue sample

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
recurrent or progressive disease following at least one chemo containing regimen for stage iiib/iv disease
Beskrivning

Recurrent disease | Progressive Disease | Chemotherapy Quantity Disease TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1335499
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0012634
UMLS CUI [3,4]
C3258246
measurable disease in accordance with response evaluation criteria in solid tumors (recist)
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
at least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose−positron emission tomography (fdg-pet) scan that is also a target lesion on computed tomography (ct) according to recist
Beskrivning

Measurable lesion Quantity FDG-PET Pretreatment | Target Lesion CT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3641247
UMLS CUI [1,4]
C3539075
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0040405
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than two prior treatments for stage iiib/iv
Beskrivning

Prior Therapy Quantity TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3258246
more than 30 days of exposure to an investigational or marketed agent that can act by egfr inhibition, or a known epidermal growth factor receptor (egfr)-related toxicity resulting in dose modifications
Beskrivning

Exposure to EGFR inhibitor | Toxicity EGFR Related | Toxicity Resulting in Dose Modification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1443775
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0034802
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0332294
UMLS CUI [3,3]
C1707811
chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization
Beskrivning

Chemotherapy | Biological treatment | Therapeutic radiology procedure | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1531518
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0013230
untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (cns) metastasis
Beskrivning

CNS metastases untreated | CNS metastases Progressive | CNS metastases Requirement Control Symptomatic | CNS metastases Requirement Anticonvulsants | CNS metastases Requirement Adrenal Cortex Hormones

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0205329
UMLS CUI [3,1]
C0686377
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0243148
UMLS CUI [3,4]
C0231220
UMLS CUI [4,1]
C0686377
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0003286
UMLS CUI [5,1]
C0686377
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0001617
history of serious systemic disease within the past 6 months prior to randomization
Beskrivning

Systemic disease Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205404
uncontrolled diabetes
Beskrivning

Diabetic - poor control

Datatyp

boolean

Alias
UMLS CUI [1]
C0421258
major surgical procedure or significant traumatic injury within 28 days prior to randomization
Beskrivning

Major surgery | Traumatic injury

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3263723
anticipation of need for a major surgical procedure during the course of the study
Beskrivning

Anticipation Patient need for Major surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679106
UMLS CUI [1,2]
C0686904
UMLS CUI [1,3]
C0679637
local palliative radiotherapy within 7 days prior to randomization or persistent adverse effects from radiotherapy that have not been resolved to grade ii or less prior to randomization
Beskrivning

Palliative course of radiotherapy Local | Adverse effect of radiation therapy Persistent | Absence Resolution CTCAE grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475092
UMLS CUI [1,2]
C0205276
UMLS CUI [2,1]
C0392615
UMLS CUI [2,2]
C0205322
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1514893
UMLS CUI [3,3]
C1516728
symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
Beskrivning

Hypercalcemia Symptomatic | Requirement Diphosphonates

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0012544
Tillbaka till toppen

Similar models

Eligibility Non-Small Cell Lung Cancer NCT00854308

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients must meet the following criteria for study entry:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma
Item
histologically confirmed nsclc
boolean
C0007131 (UMLS CUI [1])
Availability of Tumor tissue sample
Item
availability of a tumor specimen
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Recurrent disease | Progressive Disease | Chemotherapy Quantity Disease TNM clinical staging
Item
recurrent or progressive disease following at least one chemo containing regimen for stage iiib/iv disease
boolean
C0277556 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
C3258246 (UMLS CUI [3,4])
Measurable Disease
Item
measurable disease in accordance with response evaluation criteria in solid tumors (recist)
boolean
C1513041 (UMLS CUI [1])
Measurable lesion Quantity FDG-PET Pretreatment | Target Lesion CT
Item
at least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose−positron emission tomography (fdg-pet) scan that is also a target lesion on computed tomography (ct) according to recist
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3641247 (UMLS CUI [1,3])
C3539075 (UMLS CUI [1,4])
C2986546 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Quantity TNM clinical staging
Item
more than two prior treatments for stage iiib/iv
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Exposure to EGFR inhibitor | Toxicity EGFR Related | Toxicity Resulting in Dose Modification
Item
more than 30 days of exposure to an investigational or marketed agent that can act by egfr inhibition, or a known epidermal growth factor receptor (egfr)-related toxicity resulting in dose modifications
boolean
C0332157 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0034802 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0332294 (UMLS CUI [3,2])
C1707811 (UMLS CUI [3,3])
Chemotherapy | Biological treatment | Therapeutic radiology procedure | Investigational New Drugs
Item
chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
CNS metastases untreated | CNS metastases Progressive | CNS metastases Requirement Control Symptomatic | CNS metastases Requirement Anticonvulsants | CNS metastases Requirement Adrenal Cortex Hormones
Item
untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (cns) metastasis
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0243148 (UMLS CUI [3,3])
C0231220 (UMLS CUI [3,4])
C0686377 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0003286 (UMLS CUI [4,3])
C0686377 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0001617 (UMLS CUI [5,3])
Systemic disease Serious
Item
history of serious systemic disease within the past 6 months prior to randomization
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Diabetic - poor control
Item
uncontrolled diabetes
boolean
C0421258 (UMLS CUI [1])
Major surgery | Traumatic injury
Item
major surgical procedure or significant traumatic injury within 28 days prior to randomization
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
Anticipation Patient need for Major surgery
Item
anticipation of need for a major surgical procedure during the course of the study
boolean
C0679106 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0679637 (UMLS CUI [1,3])
Palliative course of radiotherapy Local | Adverse effect of radiation therapy Persistent | Absence Resolution CTCAE grades
Item
local palliative radiotherapy within 7 days prior to randomization or persistent adverse effects from radiotherapy that have not been resolved to grade ii or less prior to randomization
boolean
C0475092 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0392615 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C1514893 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
Hypercalcemia Symptomatic | Requirement Diphosphonates
Item
symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
boolean
C0020437 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0012544 (UMLS CUI [2,2])
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