ID

16466

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00523640

Nyckelord

Versioner (1)
  1. 2016-07-17 2016-07-17 -
Uppladdad den

17 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Carcinoma, Renal Cell NCT00523640

Engelsk

Eligibility Carcinoma, Renal Cell NCT00523640

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

metastatic clear cell renal cell carcinoma

Datatyp

boolean

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

Measurable disease

Datatyp

boolean

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

Age

Datatyp

boolean

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

ECOG

Datatyp

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
Beskrivning

Blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0005823
normal organ function
Beskrivning

organ function

Datatyp

boolean

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

Contraception

Datatyp

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
Beskrivning

Written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

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
Beskrivning

prior chemotherapy or radiotherapy

Datatyp

boolean

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

prior treatment with pyrimidine analogs or vegf binding agents

Datatyp

boolean

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

Other investigational or therapeutic agents

Datatyp

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
Beskrivning

Anticoagulants

Datatyp

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
Beskrivning

major surgical procedure, open biopsy, or significant traumatic injury

Datatyp

boolean

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

Serious, non healing wound, ulcer, or bone fracture

Datatyp

boolean

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

Bleeding diathesis or coagulopathy

Datatyp

boolean

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

Brain metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
uncontrolled intercurrent illness
Beskrivning

uncontrolled intercurrent illness

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
pregnant women
Beskrivning

Pregnancy

Datatyp

boolean

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

Anti-retroviral therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1963724
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Similar models

Eligibility Carcinoma, Renal Cell NCT00523640

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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