ID

28136

Description

Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00851045

Link

https://clinicaltrials.gov/show/NCT00851045

Keywords

Versions (1)
  1. 12/20/17 12/20/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 20, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer (CRC) NCT00851045

English

Eligibility Colorectal Cancer (CRC) NCT00851045

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ecog performance status (ps) ≤1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
histologically or cytologically confirmed, unresectable metastatic colorectal cancer
Description

Colorectal cancer metastatic unresectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0948380
UMLS CUI [1,2]
C1519810
measurable disease by recist guidelines
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
Description

Disease Progression | Status post First line treatment | fluoropyrimidine | oxaliplatin | bevacizumab

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1708063
UMLS CUI [3]
C0596581
UMLS CUI [4]
C0069717
UMLS CUI [5]
C0796392
available paraffin embedded tumor tissue
Description

Tumor tissue sample Paraffin Embedding Available

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0085185
UMLS CUI [1,3]
C0470187
willing to give a whole blood sample for the study of proteins and genetic polymorphisms
Description

Whole blood sample Provide Willing | Study Proteins | Study Genetic Polymorphism

Data type

boolean

Alias
UMLS CUI [1,1]
C0444256
UMLS CUI [1,2]
C1999230
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C2603343
UMLS CUI [2,2]
C0033684
UMLS CUI [3,1]
C2603343
UMLS CUI [3,2]
C0032529
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
less than 28 days elapsed since major surgery at time of randomization
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
known cns metastases
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
Description

Bleeding Risk Excessive | Anticoagulation Therapy Except Aspirin Low Dose | Thrombotic stroke | Embolic stroke

Data type

boolean

Alias
UMLS CUI [1,1]
C3251812
UMLS CUI [1,2]
C0442802
UMLS CUI [2,1]
C0003281
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C2608320
UMLS CUI [3]
C0242129
UMLS CUI [4]
C0262469
uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
clinically significant cardiovascular disease
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
Description

Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess

Data type

boolean

Alias
UMLS CUI [1]
C1879311
UMLS CUI [2]
C0151664
UMLS CUI [3]
C0243001
serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
Description

Non-healing wound Serious | Peptic Ulcer | Bone Fracture Non-healing | Secondary malignant neoplasm of skin bleeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0030920
UMLS CUI [3,1]
C0016658
UMLS CUI [3,2]
C0205301
UMLS CUI [4,1]
C0153687
UMLS CUI [4,2]
C0019080
known hiv positive
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Colorectal Cancer (CRC) NCT00851045

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
ecog performance status (ps) ≤1
boolean
C1520224 (UMLS CUI [1])
Colorectal cancer metastatic unresectable
Item
histologically or cytologically confirmed, unresectable metastatic colorectal cancer
boolean
C0948380 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
Measurable Disease
Item
measurable disease by recist guidelines
boolean
C1513041 (UMLS CUI [1])
Disease Progression | Status post First line treatment | fluoropyrimidine | oxaliplatin | bevacizumab
Item
evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0596581 (UMLS CUI [3])
C0069717 (UMLS CUI [4])
C0796392 (UMLS CUI [5])
Tumor tissue sample Paraffin Embedding Available
Item
available paraffin embedded tumor tissue
boolean
C0475358 (UMLS CUI [1,1])
C0085185 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Whole blood sample Provide Willing | Study Proteins | Study Genetic Polymorphism
Item
willing to give a whole blood sample for the study of proteins and genetic polymorphisms
boolean
C0444256 (UMLS CUI [1,1])
C1999230 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C2603343 (UMLS CUI [2,1])
C0033684 (UMLS CUI [2,2])
C2603343 (UMLS CUI [3,1])
C0032529 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Major surgery
Item
less than 28 days elapsed since major surgery at time of randomization
boolean
C0679637 (UMLS CUI [1])
CNS metastases
Item
known cns metastases
boolean
C0686377 (UMLS CUI [1])
Bleeding Risk Excessive | Anticoagulation Therapy Except Aspirin Low Dose | Thrombotic stroke | Embolic stroke
Item
excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
boolean
C3251812 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0003281 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C2608320 (UMLS CUI [2,3])
C0242129 (UMLS CUI [3])
C0262469 (UMLS CUI [4])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Cardiovascular Disease
Item
clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess
Item
history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
boolean
C1879311 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0243001 (UMLS CUI [3])
Non-healing wound Serious | Peptic Ulcer | Bone Fracture Non-healing | Secondary malignant neoplasm of skin bleeding
Item
serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0030920 (UMLS CUI [2])
C0016658 (UMLS CUI [3,1])
C0205301 (UMLS CUI [3,2])
C0153687 (UMLS CUI [4,1])
C0019080 (UMLS CUI [4,2])
HIV Seropositivity
Item
known hiv positive
boolean
C0019699 (UMLS CUI [1])
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