ID

16466

Description

A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00523640

Link

https://clinicaltrials.gov/show/NCT00523640

Keywords

Versions (1)
  1. 7/17/16 7/17/16 -
Uploaded on

July 17, 2016

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 Carcinoma, Renal Cell NCT00523640

English

Eligibility Carcinoma, Renal Cell NCT00523640

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed metastatic clear cell renal cell cancer
Description

metastatic clear cell renal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0279702
UMLS CUI [1,2]
C0027627
measurable disease
Description

Measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
age 18 or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0 - 1
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
blood pressure less than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart
Description

Blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0005823
normal organ function
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
women of child-bearing potential and men must agree to use adequate contraception
Description

Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
ability to understand and the willingness to sign a written informed consent document and to follow all required study procedures
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Description

prior chemotherapy or radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C1522449
patients may not have had prior treatment with pyrimidine analogs or vegf binding agents
Description

prior treatment with pyrimidine analogs or vegf binding agents

Data type

boolean

Alias
UMLS CUI [1]
C0280039
UMLS CUI [2]
C0596087
patients may not be receiving any other investigational or therapeutic agents
Description

Other investigational or therapeutic agents

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C1611640
patients may not be receiving therapeutic anticoagulation with warfarin, its congeners, heparin, low molecular weight heparinoids, specific thrombin inhibitors, or other similar agents patients receiving low dose coumadin (1 mg daily) for central line patency are eligible
Description

Anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0003280
major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment start, or anticipation of need for major surgical procedure during the course of the study fine needle aspirations or core biopsies within 7 days prior to treatment start are acceptable
Description

major surgical procedure, open biopsy, or significant traumatic injury

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
serious, non healing wound, ulcer, or bone fracture
Description

Serious, non healing wound, ulcer, or bone fracture

Data type

boolean

Alias
UMLS CUI [1]
C0750433
UMLS CUI [2]
C0041582
UMLS CUI [3]
C0016658
evidence of bleeding diathesis or coagulopathy
Description

Bleeding diathesis or coagulopathy

Data type

boolean

Alias
UMLS CUI [1]
C0005779
patients with known brain metastases
Description

Brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
uncontrolled intercurrent illness
Description

uncontrolled intercurrent illness

Data type

boolean

Alias
UMLS CUI [1]
C0009488
pregnant women
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study
Description

Anti-retroviral therapy

Data type

boolean

Alias
UMLS CUI [1]
C1963724
Back to the top of the page

Similar models

Eligibility Carcinoma, Renal Cell NCT00523640

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
metastatic clear cell renal cell carcinoma
Item
histologically or cytologically confirmed metastatic clear cell renal cell cancer
boolean
C0279702 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Measurable disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Age
Item
age 18 or older
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
ecog performance status of 0 - 1
boolean
C1520224 (UMLS CUI [1])
Blood pressure
Item
blood pressure less than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart
boolean
C0005823 (UMLS CUI [1])
organ function
Item
normal organ function
boolean
C0678852 (UMLS CUI [1])
Contraception
Item
women of child-bearing potential and men must agree to use adequate contraception
boolean
C0700589 (UMLS CUI [1])
Written informed consent
Item
ability to understand and the willingness to sign a written informed consent document and to follow all required study procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior chemotherapy or radiotherapy
Item
patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
boolean
C0279025 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
prior treatment with pyrimidine analogs or vegf binding agents
Item
patients may not have had prior treatment with pyrimidine analogs or vegf binding agents
boolean
C0280039 (UMLS CUI [1])
C0596087 (UMLS CUI [2])
Other investigational or therapeutic agents
Item
patients may not be receiving any other investigational or therapeutic agents
boolean
C0013230 (UMLS CUI [1])
C1611640 (UMLS CUI [2])
Anticoagulants
Item
patients may not be receiving therapeutic anticoagulation with warfarin, its congeners, heparin, low molecular weight heparinoids, specific thrombin inhibitors, or other similar agents patients receiving low dose coumadin (1 mg daily) for central line patency are eligible
boolean
C0003280 (UMLS CUI [1])
major surgical procedure, open biopsy, or significant traumatic injury
Item
major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment start, or anticipation of need for major surgical procedure during the course of the study fine needle aspirations or core biopsies within 7 days prior to treatment start are acceptable
boolean
C0543467 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
Serious, non healing wound, ulcer, or bone fracture
Item
serious, non healing wound, ulcer, or bone fracture
boolean
C0750433 (UMLS CUI [1])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Bleeding diathesis or coagulopathy
Item
evidence of bleeding diathesis or coagulopathy
boolean
C0005779 (UMLS CUI [1])
Brain metastases
Item
patients with known brain metastases
boolean
C0220650 (UMLS CUI [1])
uncontrolled intercurrent illness
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Anti-retroviral therapy
Item
hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study
boolean
C1963724 (UMLS CUI [1])
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