ID

35363

Description

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

Keywords

Versions (1)
  1. 3/2/19 3/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 2, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Colorectal Cancer NCT02314819

English

Eligibility Colorectal Cancer NCT02314819

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age | Body Weight

Data type

boolean

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

Colorectal Carcinoma

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Standard therapy failed | Standard therapy Unavailable

Data type

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
Description

Liver function | Renal function | Cardiac function | Hematologic function

Data type

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)
Description

Measurable lesion Quantity | Diameter Spiral CT scan

Data type

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
Description

Informed Consent

Data type

boolean

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

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
- pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Factor Influence Oral Administration

Data type

boolean

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

CNS metastases

Data type

boolean

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

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

Data type

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
Description

Substance Use Disorders

Data type

boolean

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

VEGFR Tyrosine Kinase Inhibitor

Data type

boolean

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

Disability | INTERCURRENT INFECTION Serious Uncontrolled

Data type

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)
Description

Proteinuria | Proteinuria g/24h

Data type

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
Description

Bleeding tendency | Independent of Event Seriousness

Data type

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.
Description

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

Data type

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
Description

Myocardial Infarction | Acute Coronary Syndrome | Coronary Artery Bypass Surgery

Data type

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
Description

Fracture Cure Lacking | Wounds Cure Lacking

Data type

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
Description

Blood coagulation Dysfunction | Bleeding tendency | Anticoagulant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0005778
UMLS CUI [1,2]
C3887504
UMLS CUI [2]
C1458140
UMLS CUI [3]
C0150457
Back to the top of the page

Similar models

Eligibility Colorectal Cancer NCT02314819

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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