ID

22836

Description

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

Link

https://clinicaltrials.gov/show/NCT00705822

Keywords

Versions (1)
  1. 6/12/17 6/12/17 -
Uploaded on

June 12, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00705822

English

Eligibility Prostatic Neoplasms NCT00705822

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Adenocarcinoma of prostate

Data type

boolean

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

Prostate carcinoma Advanced

Data type

boolean

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

Hormone Therapy

Data type

boolean

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

Testosterone measurement

Data type

boolean

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

Hematologic function | Liver function | Renal function

Data type

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.
Description

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

Data type

boolean

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

Exclusion Criteria

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

Chemotherapy | Estramustine

Data type

boolean

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

Hormone Therapy Second line | Estrogens | Progestins | Ketoconazole

Data type

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
Description

Therapeutic radiology procedure | Therapeutic radiology procedure Bone Marrow Percentage

Data type

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.
Description

Malignant Neoplasms | Interval Disease Free of | Skin carcinoma

Data type

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
Description

Comorbidity Serious

Data type

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).
Description

Antineoplastic Therapy | Luteinizing Hormone-releasing Hormone Agonist | Diphosphonates

Data type

boolean

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

Medical contraindication Estramustine

Data type

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.
Description

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

Data type

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.
Description

Spillage Pulmonary | Ascites Pulmonary

Data type

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.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Prostatic Neoplasms NCT00705822

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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