ID

18988

Beschrijving

A Study of Docetaxel Plus Carboplatin in Patients With Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00134706

Link

https://clinicaltrials.gov/show/NCT00134706

Trefwoorden

Versies (1)
  1. 28-11-16 28-11-16 -
Geüploaded op

28 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00134706

Engels

Eligibility Prostate Cancer NCT00134706

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the prostate
Beschrijving

Adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
evidence of metastatic disease
Beschrijving

Neoplasm Metastasis Evidence of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
disease progression following androgen deprivation therapy
Beschrijving

Antiandrogen therapy | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2]
C0242656
disease progression despite docetaxel-based chemotherapy
Beschrijving

Chemotherapy docetaxel Based | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0246415
UMLS CUI [1,3]
C1705938
UMLS CUI [2]
C0242656
serum testosterone levels less than 50ng/ml (unless surgically castrated). patients must continue androgen deprivation with a luteinizing hormone-releasing hormone (lhrh) analogue if they have not undergone orchiectomy.
Beschrijving

Serum testosterone measurement | Male Castration | Antiandrogen therapy | Luteinizing Hormone-releasing Hormone Agonist | Orchiectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0428413
UMLS CUI [2]
C0007347
UMLS CUI [3]
C0279492
UMLS CUI [4]
C1518041
UMLS CUI [5]
C0029189
no use of antiandrogens for at least 4 weeks
Beschrijving

Androgen Antagonists

Datatype

boolean

Alias
UMLS CUI [1]
C0002842
cancer and leukemia group b (calgb) performance status less than or equal to 2
Beschrijving

Cancer and Leukemia Group B performance status

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516238
UMLS CUI [1,2]
C1518965
acceptable white blood cell (wbc), platelets, creatinine and ast counts
Beschrijving

White Blood Cell Count procedure | Platelet Count measurement | Creatinine measurement, serum | Aspartate aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0201899
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant peripheral neuropathy defined as grade 2 or higher
Beschrijving

Peripheral Neuropathy Significant CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C1516728
within 4 weeks since completing external beam radiotherapy or 8 weeks since completing radiopharmaceutical therapy (strontium, samarium)
Beschrijving

External Beam Radiation Therapy Complete | radiopharmaceutical therapy Complete | Strontium | Samarium

Datatype

boolean

Alias
UMLS CUI [1,1]
C1517033
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C2094663
UMLS CUI [2,2]
C0205197
UMLS CUI [3]
C0038467
UMLS CUI [4]
C0036147
prior platinum-based chemotherapy (cisplatin or carboplatin) for hormone- refractory prostate cancer
Beschrijving

Chemotherapy Platinum-Based Hormone refractory prostate cancer | Cisplatin | Carboplatin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514162
UMLS CUI [1,3]
C1328504
UMLS CUI [2]
C0008838
UMLS CUI [3]
C0079083
concomitant chemotherapy, investigational agents or systemic steroids
Beschrijving

Chemotherapy | Investigational New Drugs | systemic steroids

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2825233
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Similar models

Eligibility Prostate Cancer NCT00134706

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Neoplasm Metastasis Evidence of
Item
evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Antiandrogen therapy | Disease Progression
Item
disease progression following androgen deprivation therapy
boolean
C0279492 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Chemotherapy docetaxel Based | Disease Progression
Item
disease progression despite docetaxel-based chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
Serum testosterone measurement | Male Castration | Antiandrogen therapy | Luteinizing Hormone-releasing Hormone Agonist | Orchiectomy
Item
serum testosterone levels less than 50ng/ml (unless surgically castrated). patients must continue androgen deprivation with a luteinizing hormone-releasing hormone (lhrh) analogue if they have not undergone orchiectomy.
boolean
C0428413 (UMLS CUI [1])
C0007347 (UMLS CUI [2])
C0279492 (UMLS CUI [3])
C1518041 (UMLS CUI [4])
C0029189 (UMLS CUI [5])
Androgen Antagonists
Item
no use of antiandrogens for at least 4 weeks
boolean
C0002842 (UMLS CUI [1])
Cancer and Leukemia Group B performance status
Item
cancer and leukemia group b (calgb) performance status less than or equal to 2
boolean
C1516238 (UMLS CUI [1,1])
C1518965 (UMLS CUI [1,2])
White Blood Cell Count procedure | Platelet Count measurement | Creatinine measurement, serum | Aspartate aminotransferase measurement
Item
acceptable white blood cell (wbc), platelets, creatinine and ast counts
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Peripheral Neuropathy Significant CTCAE Grades
Item
significant peripheral neuropathy defined as grade 2 or higher
boolean
C0031117 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
External Beam Radiation Therapy Complete | radiopharmaceutical therapy Complete | Strontium | Samarium
Item
within 4 weeks since completing external beam radiotherapy or 8 weeks since completing radiopharmaceutical therapy (strontium, samarium)
boolean
C1517033 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C2094663 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0038467 (UMLS CUI [3])
C0036147 (UMLS CUI [4])
Chemotherapy Platinum-Based Hormone refractory prostate cancer | Cisplatin | Carboplatin
Item
prior platinum-based chemotherapy (cisplatin or carboplatin) for hormone- refractory prostate cancer
boolean
C0392920 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
C1328504 (UMLS CUI [1,3])
C0008838 (UMLS CUI [2])
C0079083 (UMLS CUI [3])
Chemotherapy | Investigational New Drugs | systemic steroids
Item
concomitant chemotherapy, investigational agents or systemic steroids
boolean
C0392920 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2825233 (UMLS CUI [3])
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