ID

36389

Description

Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703); ODM derived from: https://clinicaltrials.gov/show/NCT02332499

Link

https://clinicaltrials.gov/show/NCT02332499

Keywords

Versions (1)
  1. 5/9/19 5/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT02332499

English

Eligibility Metastatic Colorectal Cancer NCT02332499

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed and dated informed consent；
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. histological or cytological documentation of adenocarcinoma of the colon or rectum；
Description

Adenocarcinoma of colon | Adenocarcinoma of rectum

Data type

boolean

Alias
UMLS CUI [1]
C0338106
UMLS CUI [2]
C0149978
3. subjects with metastatic colorectal cancer (stage iv),with measurable disease (using recist1.1)；
Description

Colorectal cancer metastatic TNM clinical staging | Measurable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0948380
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C1513041
4. progression during or within 3 months following the last administration of approved standard therapies which must include fluorouracil or its derivatives, oxaliplatin, irinotecan；
Description

Disease Progression Following Standard therapy | Fluorouracil | Fluorouracil Derivative | oxaliplatin | irinotecan

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C2936643
UMLS CUI [2]
C0016360
UMLS CUI [3,1]
C0016360
UMLS CUI [3,2]
C1527240
UMLS CUI [4]
C0069717
UMLS CUI [5]
C0123931
5. ecog ps:0-1,life expectancy of more than 3 months；
Description

ECOG performance status | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
6. main organs function is normal；
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
7. main organs function is normal；
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment with anlotinib；
Description

anlotinib

Data type

boolean

Alias
UMLS CUI [1]
C4519250
2. major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug；
Description

Major surgery | Incisional biopsy | Traumatic injury

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
3. known brain metastases；
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
4. patients with severe and failed to controlled diseases；
Description

Disease Severe Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
5. patients occurred venous thromboembolic events within 6 months；
Description

Thromboembolism of vein

Data type

boolean

Alias
UMLS CUI [1]
C1997614
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Similar models

Eligibility Metastatic Colorectal Cancer NCT02332499

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. signed and dated informed consent；
boolean
C0021430 (UMLS CUI [1])
Adenocarcinoma of colon | Adenocarcinoma of rectum
Item
2. histological or cytological documentation of adenocarcinoma of the colon or rectum；
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
Colorectal cancer metastatic TNM clinical staging | Measurable Disease
Item
3. subjects with metastatic colorectal cancer (stage iv),with measurable disease (using recist1.1)；
boolean
C0948380 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2])
Disease Progression Following Standard therapy | Fluorouracil | Fluorouracil Derivative | oxaliplatin | irinotecan
Item
4. progression during or within 3 months following the last administration of approved standard therapies which must include fluorouracil or its derivatives, oxaliplatin, irinotecan；
boolean
C0242656 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C2936643 (UMLS CUI [1,3])
C0016360 (UMLS CUI [2])
C0016360 (UMLS CUI [3,1])
C1527240 (UMLS CUI [3,2])
C0069717 (UMLS CUI [4])
C0123931 (UMLS CUI [5])
ECOG performance status | Life Expectancy
Item
5. ecog ps:0-1,life expectancy of more than 3 months；
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Organ function
Item
6. main organs function is normal；
boolean
C0678852 (UMLS CUI [1])
Organ function
Item
7. main organs function is normal；
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
anlotinib
Item
1. prior treatment with anlotinib；
boolean
C4519250 (UMLS CUI [1])
Major surgery | Incisional biopsy | Traumatic injury
Item
2. major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug；
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
Metastatic malignant neoplasm to brain
Item
3. known brain metastases；
boolean
C0220650 (UMLS CUI [1])
Disease Severe Uncontrolled
Item
4. patients with severe and failed to controlled diseases；
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Thromboembolism of vein
Item
5. patients occurred venous thromboembolic events within 6 months；
boolean
C1997614 (UMLS CUI [1])
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