ID

31631

Beskrivning

Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00924807

Länk

https://clinicaltrials.gov/show/NCT00924807

Nyckelord

Versioner (1)
  1. 2018-09-14 2018-09-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00924807

Engelsk

Eligibility Prostate Cancer NCT00924807

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically confirmed intermediate or high risk prostate adenocarcinoma. intermediate risk disease comprises t2b/c tumors, gleason 7 histology, or psa 10-20. high risk tumors comprise t3-4, gleason 8 or higher histology, or psa greater than 20.
Beskrivning

Adenocarcinoma of prostate Intermediate Risk | Adenocarcinoma of prostate High risk | TNM clinical staging | Gleason score | Prostate specific antigen measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3640764
UMLS CUI [2,1]
C0007112
UMLS CUI [2,2]
C4319571
UMLS CUI [3]
C3258246
UMLS CUI [4]
C3203027
UMLS CUI [5]
C0201544
age > 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of greater than 5 years.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
patients must have normal organ and marrow function.
Beskrivning

Organ function | Bone Marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
no pelvic lymph node metastases based on pelvic ct scan or mri.
Beskrivning

Absence Secondary malignant neoplasm of lymph node Pelvic CT of Pelvis | Absence Secondary malignant neoplasm of lymph node Pelvic MRI of Pelvis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0686619
UMLS CUI [1,3]
C0030797
UMLS CUI [1,4]
C0412628
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0686619
UMLS CUI [2,3]
C0030797
UMLS CUI [2,4]
C0203201
no bone metastasis. a whole body bone scan is required to rule out metastatic disease.
Beskrivning

Secondary malignant neoplasm of bone Absent | Whole body bone scan Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3863086
UMLS CUI [2,2]
C1514873
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any previous, radiotherapy, or chemotherapy, or more than 4 weeks of androgen deprivation hormonal therapy for the treatment of prostate adenocarcinoma.
Beskrivning

Prior radiation therapy Adenocarcinoma of prostate | Prior Chemotherapy Adenocarcinoma of prostate | Antiandrogen therapy Adenocarcinoma of prostate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0007112
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0007112
UMLS CUI [3,1]
C0279492
UMLS CUI [3,2]
C0007112
patients may not be receiving any other investigational agents.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or other agents used in this study.
Beskrivning

Allergic Reaction Compound Sorafenib Similar | Allergic Reaction Compound Investigational New Drugs Similar

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C1516119
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C0013230
UMLS CUI [2,4]
C2348205
known human immunodeficiency virus (hiv) infection or chronic hepatitis b or c.
Beskrivning

HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
patients receiving anti-coagulation treatment with an agent such as warfarin or heparin will not be allowed to participate.
Beskrivning

Anticoagulation Therapy | Warfarin | Heparin

Datatyp

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0019134
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Similar models

Eligibility Prostate Cancer NCT00924807

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate Intermediate Risk | Adenocarcinoma of prostate High risk | TNM clinical staging | Gleason score | Prostate specific antigen measurement
Item
patients must have histologically confirmed intermediate or high risk prostate adenocarcinoma. intermediate risk disease comprises t2b/c tumors, gleason 7 histology, or psa 10-20. high risk tumors comprise t3-4, gleason 8 or higher histology, or psa greater than 20.
boolean
C0007112 (UMLS CUI [1,1])
C3640764 (UMLS CUI [1,2])
C0007112 (UMLS CUI [2,1])
C4319571 (UMLS CUI [2,2])
C3258246 (UMLS CUI [3])
C3203027 (UMLS CUI [4])
C0201544 (UMLS CUI [5])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 5 years.
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
patients must have normal organ and marrow function.
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Absence Secondary malignant neoplasm of lymph node Pelvic CT of Pelvis | Absence Secondary malignant neoplasm of lymph node Pelvic MRI of Pelvis
Item
no pelvic lymph node metastases based on pelvic ct scan or mri.
boolean
C0332197 (UMLS CUI [1,1])
C0686619 (UMLS CUI [1,2])
C0030797 (UMLS CUI [1,3])
C0412628 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0686619 (UMLS CUI [2,2])
C0030797 (UMLS CUI [2,3])
C0203201 (UMLS CUI [2,4])
Secondary malignant neoplasm of bone Absent | Whole body bone scan Required
Item
no bone metastasis. a whole body bone scan is required to rule out metastatic disease.
boolean
C0153690 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3863086 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Prior radiation therapy Adenocarcinoma of prostate | Prior Chemotherapy Adenocarcinoma of prostate | Antiandrogen therapy Adenocarcinoma of prostate
Item
any previous, radiotherapy, or chemotherapy, or more than 4 weeks of androgen deprivation hormonal therapy for the treatment of prostate adenocarcinoma.
boolean
C0279134 (UMLS CUI [1,1])
C0007112 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0007112 (UMLS CUI [2,2])
C0279492 (UMLS CUI [3,1])
C0007112 (UMLS CUI [3,2])
Investigational New Drugs
Item
patients may not be receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Allergic Reaction Compound Sorafenib Similar | Allergic Reaction Compound Investigational New Drugs Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or other agents used in this study.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C1516119 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
known human immunodeficiency virus (hiv) infection or chronic hepatitis b or c.
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
Anticoagulation Therapy | Warfarin | Heparin
Item
patients receiving anti-coagulation treatment with an agent such as warfarin or heparin will not be allowed to participate.
boolean
C0003281 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
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