ID

22836

Beskrivning

Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00705822

Länk

https://clinicaltrials.gov/show/NCT00705822

Nyckelord

  1. 2017-06-12 2017-06-12 -
Uppladdad den

12 juni 2017

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Prostatic Neoplasms NCT00705822

Eligibility Prostatic Neoplasms NCT00705822

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological confirmation of prostate adenocarcinoma
Beskrivning

Adenocarcinoma of prostate

Datatyp

boolean

Alias
UMLS CUI [1]
C0007112
advanced prostate carcinoma.
Beskrivning

Prostate carcinoma Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0205179
previous treatment with hormones
Beskrivning

Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279025
levels of testosterone < 50 ng/dl
Beskrivning

Testosterone measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0523912
good hematological, liver and kidney function
Beskrivning

Hematologic function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects.
Beskrivning

Operative Surgical Procedures | Therapeutic radiology procedure | Adverse effects Patient recovered

Datatyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0879626
UMLS CUI [3,2]
C1115804
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous chemotherapy (estramustine included).
Beskrivning

Chemotherapy | Estramustine

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0014921
second line hormonotherapy (oestrogens, gestagens, ketoconazole, ...included)
Beskrivning

Hormone Therapy Second line | Estrogens | Progestins | Ketoconazole

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1710038
UMLS CUI [2]
C0014939
UMLS CUI [3]
C0033306
UMLS CUI [4]
C0022625
previous treatment with radiotherapy (isotopes) or previous radiotherapy over > 25% of the marrow
Beskrivning

Therapeutic radiology procedure | Therapeutic radiology procedure Bone Marrow Percentage

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0005953
UMLS CUI [2,3]
C0439165
any malignant process with a free disease interval under 5 years, exception done to non-melanoma skin cancer.
Beskrivning

Malignant Neoplasms | Interval Disease Free of | Skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1272706
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [3]
C0699893
concomitant serious diseases
Beskrivning

Comorbidity Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
concomitant treatment with any other neoplassic therapy (exception done to lhrh agonists and/or biphosphonates).
Beskrivning

Antineoplastic Therapy | Luteinizing Hormone-releasing Hormone Agonist | Diphosphonates

Datatyp

boolean

Alias
UMLS CUI [1]
C2346834
UMLS CUI [2]
C1518041
UMLS CUI [3]
C0012544
contraindication for the treatment with estramustine.
Beskrivning

Medical contraindication Estramustine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0014921
previous history of pulmonary embolism, thromboembolic disease, previous treatment with anticoagulants (except aspirin), active thrombophlebitis or hypercoagulation.
Beskrivning

Pulmonary Embolism | Thromboembolism | Anticoagulants | Aspirin | Thrombophlebitis | Thrombophilia

Datatyp

boolean

Alias
UMLS CUI [1]
C0034065
UMLS CUI [2]
C0040038
UMLS CUI [3]
C0003280
UMLS CUI [4]
C0004057
UMLS CUI [5]
C0040046
UMLS CUI [6]
C0398623
previous history of pulmonary spillage or ascitis.
Beskrivning

Spillage Pulmonary | Ascites Pulmonary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015376
UMLS CUI [1,2]
C2709248
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C2709248
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Prostatic Neoplasms NCT00705822

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histological or cytological confirmation of prostate adenocarcinoma
boolean
C0007112 (UMLS CUI [1])
Prostate carcinoma Advanced
Item
advanced prostate carcinoma.
boolean
C0600139 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Hormone Therapy
Item
previous treatment with hormones
boolean
C0279025 (UMLS CUI [1])
Testosterone measurement
Item
levels of testosterone < 50 ng/dl
boolean
C0523912 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
good hematological, liver and kidney function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Operative Surgical Procedures | Therapeutic radiology procedure | Adverse effects Patient recovered
Item
previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects.
boolean
C0543467 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0879626 (UMLS CUI [3,1])
C1115804 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Estramustine
Item
previous chemotherapy (estramustine included).
boolean
C0392920 (UMLS CUI [1])
C0014921 (UMLS CUI [2])
Hormone Therapy Second line | Estrogens | Progestins | Ketoconazole
Item
second line hormonotherapy (oestrogens, gestagens, ketoconazole, ...included)
boolean
C0279025 (UMLS CUI [1,1])
C1710038 (UMLS CUI [1,2])
C0014939 (UMLS CUI [2])
C0033306 (UMLS CUI [3])
C0022625 (UMLS CUI [4])
Therapeutic radiology procedure | Therapeutic radiology procedure Bone Marrow Percentage
Item
previous treatment with radiotherapy (isotopes) or previous radiotherapy over > 25% of the marrow
boolean
C1522449 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Malignant Neoplasms | Interval Disease Free of | Skin carcinoma
Item
any malignant process with a free disease interval under 5 years, exception done to non-melanoma skin cancer.
boolean
C0006826 (UMLS CUI [1])
C1272706 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0699893 (UMLS CUI [3])
Comorbidity Serious
Item
concomitant serious diseases
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Antineoplastic Therapy | Luteinizing Hormone-releasing Hormone Agonist | Diphosphonates
Item
concomitant treatment with any other neoplassic therapy (exception done to lhrh agonists and/or biphosphonates).
boolean
C2346834 (UMLS CUI [1])
C1518041 (UMLS CUI [2])
C0012544 (UMLS CUI [3])
Medical contraindication Estramustine
Item
contraindication for the treatment with estramustine.
boolean
C1301624 (UMLS CUI [1,1])
C0014921 (UMLS CUI [1,2])
Pulmonary Embolism | Thromboembolism | Anticoagulants | Aspirin | Thrombophlebitis | Thrombophilia
Item
previous history of pulmonary embolism, thromboembolic disease, previous treatment with anticoagulants (except aspirin), active thrombophlebitis or hypercoagulation.
boolean
C0034065 (UMLS CUI [1])
C0040038 (UMLS CUI [2])
C0003280 (UMLS CUI [3])
C0004057 (UMLS CUI [4])
C0040046 (UMLS CUI [5])
C0398623 (UMLS CUI [6])
Spillage Pulmonary | Ascites Pulmonary
Item
previous history of pulmonary spillage or ascitis.
boolean
C0015376 (UMLS CUI [1,1])
C2709248 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2,1])
C2709248 (UMLS CUI [2,2])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])

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