ID

18995

Beskrivning

Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00215709

Länk

https://clinicaltrials.gov/show/NCT00215709

Nyckelord

Versioner (1)
  1. 2016-11-29 2016-11-29 -
Uppladdad den

29 november 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00215709

Engelsk

Eligibility Prostate Cancer NCT00215709

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 65 years;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed adenocarcinoma of the prostate;
Beskrivning

Adenocarcinoma of prostate

Datatyp

boolean

Alias
UMLS CUI [1]
C0007112
metastatic disease;
Beskrivning

Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
unresponsive or refractory to hormonal therapy, as defined by at least 1 of the following criteria: progression of bidimensionally measurable disease; progression of evaluable but not measurable disease (bone scan); at least 2 consecutive rises in psa at least 1 week apart;
Beskrivning

Hormone Therapy refractory | Measurable Disease 2-Dimensional Progressing | Evaluable Disease Progressing Scan of bone | Raised prostate specific antigen Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1705052
UMLS CUI [2,3]
C0205329
UMLS CUI [3,1]
C1516986
UMLS CUI [3,2]
C0205329
UMLS CUI [3,3]
C0203668
UMLS CUI [4,1]
C0178415
UMLS CUI [4,2]
C1265611
patients must have serum testosterone levels < 50 ng/ml at time of study entry. for patients who are medically castrated, lutenizing hormone releasing hormone analog must continue to maintain testicular suppression;
Beskrivning

Serum testosterone measurement | Medical Castration | Luteinizing Hormone-releasing Hormone Agonist | Testicular ablation

Datatyp

boolean

Alias
UMLS CUI [1]
C0428413
UMLS CUI [2]
C1513054
UMLS CUI [3]
C1518041
UMLS CUI [4]
C1298674
prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or nilutamide) allowed if disease progression occurred. no evidence of response after antiandrogen withdrawal within 4 weeks for patients treated with flutamide, ketoconazole, nilutamide and 6 weeks for patients treated with bicalutamide;
Beskrivning

Nonsteroidal Anti-Androgens | Flutamide | Ketoconazole | bicalutamide | nilutamide | Disease Progression | Response Post Androgen Antagonists Withdrawal

Datatyp

boolean

Alias
UMLS CUI [1]
C1320169
UMLS CUI [2]
C0016384
UMLS CUI [3]
C0022625
UMLS CUI [4]
C0285590
UMLS CUI [5]
C0068771
UMLS CUI [6]
C0242656
UMLS CUI [7,1]
C1704632
UMLS CUI [7,2]
C0687676
UMLS CUI [7,3]
C0002842
UMLS CUI [7,4]
C2349954
chemotherapy naïve;
Beskrivning

Chemotherapy naive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0919936
full recovery from the effects of any prior surgery or radiation therapy. at least 4 weeks since any radiation therapy;
Beskrivning

Effect Operative Surgical Procedures | Effect Therapeutic radiology procedure | Patient Recovered

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1280500
UMLS CUI [1,2]
C0543467
UMLS CUI [2,1]
C1280500
UMLS CUI [2,2]
C1522449
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0521108
ecog performance status 0-2;
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate kidney, liver, and bone marrow functions;
Beskrivning

Renal function | Liver function | Bone Marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
signed study-specific informed consent form.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent chemotherapy or immunotherapy;
Beskrivning

Chemotherapy | Immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
patients who have received an investigational drug within 4 weeks of registration;
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
prior or concurrent malignancies (other than surgically treated carcinoma in situ of the cervix and squamous or basal cell carcinoma of the skin) within the preceding five years;
Beskrivning

Malignant Neoplasms | Operative Surgical Procedure Carcinoma in situ of uterine cervix | Operative Surgical Procedure Squamous cell carcinoma of skin | Operative Surgical Procedure Basal cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0007117
serious medical or psychiatric illness which would prevent informed consent;
Beskrivning

Illness Serious Preventing Informed Consent | Mental disorder Serious Preventing Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0021430
life expectancy < 3 months;
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled;
Beskrivning

Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205318
known hypersensitivity to study drug or to other drugs formulated with polysorbate 80.
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity Polysorbate 80 Formulation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0032601
UMLS CUI [2,3]
C1705957
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Similar models

Eligibility Prostate Cancer NCT00215709

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 65 years;
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of the prostate;
boolean
C0007112 (UMLS CUI [1])
Neoplasm Metastasis
Item
metastatic disease;
boolean
C0027627 (UMLS CUI [1])
Hormone Therapy refractory | Measurable Disease 2-Dimensional Progressing | Evaluable Disease Progressing Scan of bone | Raised prostate specific antigen Quantity
Item
unresponsive or refractory to hormonal therapy, as defined by at least 1 of the following criteria: progression of bidimensionally measurable disease; progression of evaluable but not measurable disease (bone scan); at least 2 consecutive rises in psa at least 1 week apart;
boolean
C0279025 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
C0205329 (UMLS CUI [2,3])
C1516986 (UMLS CUI [3,1])
C0205329 (UMLS CUI [3,2])
C0203668 (UMLS CUI [3,3])
C0178415 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Serum testosterone measurement | Medical Castration | Luteinizing Hormone-releasing Hormone Agonist | Testicular ablation
Item
patients must have serum testosterone levels < 50 ng/ml at time of study entry. for patients who are medically castrated, lutenizing hormone releasing hormone analog must continue to maintain testicular suppression;
boolean
C0428413 (UMLS CUI [1])
C1513054 (UMLS CUI [2])
C1518041 (UMLS CUI [3])
C1298674 (UMLS CUI [4])
Nonsteroidal Anti-Androgens | Flutamide | Ketoconazole | bicalutamide | nilutamide | Disease Progression | Response Post Androgen Antagonists Withdrawal
Item
prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or nilutamide) allowed if disease progression occurred. no evidence of response after antiandrogen withdrawal within 4 weeks for patients treated with flutamide, ketoconazole, nilutamide and 6 weeks for patients treated with bicalutamide;
boolean
C1320169 (UMLS CUI [1])
C0016384 (UMLS CUI [2])
C0022625 (UMLS CUI [3])
C0285590 (UMLS CUI [4])
C0068771 (UMLS CUI [5])
C0242656 (UMLS CUI [6])
C1704632 (UMLS CUI [7,1])
C0687676 (UMLS CUI [7,2])
C0002842 (UMLS CUI [7,3])
C2349954 (UMLS CUI [7,4])
Chemotherapy naive
Item
chemotherapy naïve;
boolean
C0392920 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Effect Operative Surgical Procedures | Effect Therapeutic radiology procedure | Patient Recovered
Item
full recovery from the effects of any prior surgery or radiation therapy. at least 4 weeks since any radiation therapy;
boolean
C1280500 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1280500 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0521108 (UMLS CUI [3,2])
ECOG performance status
Item
ecog performance status 0-2;
boolean
C1520224 (UMLS CUI [1])
Renal function | Liver function | Bone Marrow function
Item
adequate kidney, liver, and bone marrow functions;
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Informed Consent
Item
signed study-specific informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Immunotherapy
Item
concurrent chemotherapy or immunotherapy;
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
Investigational New Drugs
Item
patients who have received an investigational drug within 4 weeks of registration;
boolean
C0013230 (UMLS CUI [1])
Malignant Neoplasms | Operative Surgical Procedure Carcinoma in situ of uterine cervix | Operative Surgical Procedure Squamous cell carcinoma of skin | Operative Surgical Procedure Basal cell carcinoma
Item
prior or concurrent malignancies (other than surgically treated carcinoma in situ of the cervix and squamous or basal cell carcinoma of the skin) within the preceding five years;
boolean
C0006826 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
Illness Serious Preventing Informed Consent | Mental disorder Serious Preventing Informed Consent
Item
serious medical or psychiatric illness which would prevent informed consent;
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0021430 (UMLS CUI [2,4])
Life Expectancy
Item
life expectancy < 3 months;
boolean
C0023671 (UMLS CUI [1])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled
Item
active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled;
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Polysorbate 80 Formulation
Item
known hypersensitivity to study drug or to other drugs formulated with polysorbate 80.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C1705957 (UMLS CUI [2,3])
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