ID

35363

Descripción

A Phase III Trial Evaluating Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients （FRESCO); ODM derived from: https://clinicaltrials.gov/show/NCT02314819

Link

https://clinicaltrials.gov/show/NCT02314819

Palabras clave

Versiones (1)
  1. 2/3/19 2/3/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de marzo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT02314819

Inglés

Eligibility Colorectal Cancer NCT02314819

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥ 18 and ≤ 75 years of age , with ≥ 40kg
Descripción

Age | Body Weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0005910
histological or cytological confirmed colorectal cancer
Descripción

Colorectal Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009402
ecog performance status of 0-1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
standard regimen failed or no standard regimen available
Descripción

Standard therapy failed | Standard therapy Unavailable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0686905
adequate hepatic, renal, heart, and hematologic functions
Descripción

Liver function | Renal function | Cardiac function | Hematologic function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232164
UMLS CUI [4]
C0221130
at least one measurable lesion (larger than 10 mm in diameter by spiral ct scan)
Descripción

Measurable lesion Quantity | Diameter Spiral CT scan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1301886
UMLS CUI [2,2]
C0860888
signed and dated informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
- pregnant or lactating women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any factors that influence the usage of oral administration
Descripción

Factor Influence Oral Administration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0001563
evidence of cns metastasis
Descripción

CNS metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0686377
intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
Descripción

Intercurrent disease | Uncontrolled hypertension | Coronary Artery Disease | Cardiac Arrhythmia | Heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277557
UMLS CUI [2]
C1868885
UMLS CUI [3]
C1956346
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0018801
abuse of alcohol or drugs
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
less than 4 weeks from the last clinical trial - previous treatment with vegfr inhibition
Descripción

VEGFR Tyrosine Kinase Inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2985521
disability of serious uncontrolled intercurrence infection
Descripción

Disability | INTERCURRENT INFECTION Serious Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0231170
UMLS CUI [2,1]
C0240021
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
proteinuria ≥ 2+ (1.0g/24hr)
Descripción

Proteinuria | Proteinuria g/24h

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0033687
UMLS CUI [2,1]
C0033687
UMLS CUI [2,2]
C0439417
have evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness
Descripción

Bleeding tendency | Independent of Event Seriousness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C1547644
within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
Descripción

Arterial thromboembolism | Venous Thromboembolism | Cerebrovascular accident | Transient Ischemic Attack

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3544094
UMLS CUI [2]
C1861172
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or cabg
Descripción

Myocardial Infarction | Acute Coronary Syndrome | Coronary Artery Bypass Surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0948089
UMLS CUI [3]
C0010055
bone fracture or wounds that was not cured for a long time
Descripción

Fracture Cure Lacking | Wounds Cure Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0016658
UMLS CUI [1,2]
C1880198
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C0043250
UMLS CUI [2,2]
C1880198
UMLS CUI [2,3]
C0332268
coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy
Descripción

Blood coagulation Dysfunction | Bleeding tendency | Anticoagulant therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005778
UMLS CUI [1,2]
C3887504
UMLS CUI [2]
C1458140
UMLS CUI [3]
C0150457
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Similar models

Eligibility Colorectal Cancer NCT02314819

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Body Weight
Item
≥ 18 and ≤ 75 years of age , with ≥ 40kg
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Colorectal Carcinoma
Item
histological or cytological confirmed colorectal cancer
boolean
C0009402 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Standard therapy failed | Standard therapy Unavailable
Item
standard regimen failed or no standard regimen available
boolean
C2936643 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0686905 (UMLS CUI [2,2])
Liver function | Renal function | Cardiac function | Hematologic function
Item
adequate hepatic, renal, heart, and hematologic functions
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
C0221130 (UMLS CUI [4])
Measurable lesion Quantity | Diameter Spiral CT scan
Item
at least one measurable lesion (larger than 10 mm in diameter by spiral ct scan)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2,1])
C0860888 (UMLS CUI [2,2])
Informed Consent
Item
signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
- pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Factor Influence Oral Administration
Item
any factors that influence the usage of oral administration
boolean
C1521761 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0001563 (UMLS CUI [1,3])
CNS metastases
Item
evidence of cns metastasis
boolean
C0686377 (UMLS CUI [1])
Intercurrent disease | Uncontrolled hypertension | Coronary Artery Disease | Cardiac Arrhythmia | Heart failure
Item
intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
boolean
C0277557 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0018801 (UMLS CUI [5])
Substance Use Disorders
Item
abuse of alcohol or drugs
boolean
C0038586 (UMLS CUI [1])
VEGFR Tyrosine Kinase Inhibitor
Item
less than 4 weeks from the last clinical trial - previous treatment with vegfr inhibition
boolean
C2985521 (UMLS CUI [1])
Disability | INTERCURRENT INFECTION Serious Uncontrolled
Item
disability of serious uncontrolled intercurrence infection
boolean
C0231170 (UMLS CUI [1])
C0240021 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Proteinuria | Proteinuria g/24h
Item
proteinuria ≥ 2+ (1.0g/24hr)
boolean
C0033687 (UMLS CUI [1])
C0033687 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
Bleeding tendency | Independent of Event Seriousness
Item
have evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness
boolean
C1458140 (UMLS CUI [1])
C0332291 (UMLS CUI [2,1])
C1547644 (UMLS CUI [2,2])
Arterial thromboembolism | Venous Thromboembolism | Cerebrovascular accident | Transient Ischemic Attack
Item
within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
boolean
C3544094 (UMLS CUI [1])
C1861172 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Myocardial Infarction | Acute Coronary Syndrome | Coronary Artery Bypass Surgery
Item
within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or cabg
boolean
C0027051 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Fracture Cure Lacking | Wounds Cure Lacking
Item
bone fracture or wounds that was not cured for a long time
boolean
C0016658 (UMLS CUI [1,1])
C1880198 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0043250 (UMLS CUI [2,1])
C1880198 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Blood coagulation Dysfunction | Bleeding tendency | Anticoagulant therapy
Item
coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy
boolean
C0005778 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
C1458140 (UMLS CUI [2])
C0150457 (UMLS CUI [3])
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