ID

25022

Beschrijving

Docetaxel in Treating Patients With Relapsed Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00482274

Link

https://clinicaltrials.gov/show/NCT00482274

Trefwoorden

Versies (1)
  1. 24-08-17 24-08-17 -
Geüploaded op

24 augustus 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00482274

Engels

Eligibility Prostate Cancer NCT00482274

1 Formulieren  
Criteria
Beschrijving

Criteria

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed adenocarcinoma of the prostate.
Beschrijving

Adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
2. prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy.
Beschrijving

First line treatment Prostate carcinoma | Radical prostatectomy | External Beam Radiation Therapy | Brachytherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C0194810
UMLS CUI [3]
C1517033
UMLS CUI [4]
C0006098
3. serum psa > 0.2 ng/dl following 8 months of androgen deprivation therapy or a nadir psa >0.2 ng/dl and at least 1 subsequent psa values at the same or higher level, if prior to 8 months.
Beschrijving

PSA measurement | Antiandrogen therapy | PSA Nadir | PSA measurement Following Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2]
C0279492
UMLS CUI [3,1]
C0138741
UMLS CUI [3,2]
C1708760
UMLS CUI [4,1]
C0201544
UMLS CUI [4,2]
C0332282
UMLS CUI [4,3]
C1265611
4. serum testosterone < 50 ng/ml.
Beschrijving

Serum testosterone measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0428413
5. no evidence of metastases on bone scan.
Beschrijving

Neoplasm Metastasis Absent Bone scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0203668
6. no evidence of metastases on ct scan of the abdomen and pelvis.
Beschrijving

Neoplasm Metastasis Absent CT of abdomen | Neoplasm Metastasis Absent CT of Pelvis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0412620
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0412628
7. ecog performance status < 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
8. laboratory criteria for entry: absolute neutrophil count ≥ 1.2 k/cu mm, platelets ≥
Beschrijving

Laboratory criteria | Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
100 k/cu mm, serum bilirubin ≤ upper limit of normal (uln), sgot and sgpt ≤ 1.5 times institutional uln if alkaline phosphatase ≤ uln, alkaline phosphatase ≤ 5 times uln if sgot and sgpt are ≤ uln, a serum creatinine ≤ 2 times institutional uln.
Beschrijving

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
UMLS CUI [5]
C0201976
9. signed informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. a second active malignancy during the last 5 years, except adequately treated non-melanoma skin cancer.
Beschrijving

Neoplasms, Second Primary | Exception Skin carcinoma Treated

Datatype

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
2. life expectancy < 3 months.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
3. grade 2 or higher peripheral neuropathy.
Beschrijving

Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
4. prior investigational agent within the past 28 days.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
5. less than a 10% decrease (or continued rise) in psa in response to initial androgen-deprivation therapy.
Beschrijving

Antiandrogen therapy Initial | PSA decreased Percentage | Raised PSA

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0205265
UMLS CUI [2,1]
C0178414
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C0178415
6. more than 12 months since initiation of androgen-deprivation therapy.
Beschrijving

Duration Since Antiandrogen therapy Initiation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C0279492
UMLS CUI [1,4]
C1704686
7. prior docetaxel chemotherapy.
Beschrijving

docetaxel

Datatype

boolean

Alias
UMLS CUI [1]
C0246415
8. patients recently (within 28 days) started on corticosteroids, with the exception of inhaled and topical steroids. patients on stable doses of systemic corticosteroids will be eligible.
Beschrijving

Adrenal Cortex Hormones Started | Exception inhaled steroids | Exception topical steroids | CORTICOSTEROIDS FOR SYSTEMIC USE Dose Stable eligible

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1272689
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2065041
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2064827
UMLS CUI [4,1]
C3653708
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [4,4]
C1548635
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Similar models

Eligibility Prostate Cancer NCT00482274

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
1. histologically confirmed adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
First line treatment Prostate carcinoma | Radical prostatectomy | External Beam Radiation Therapy | Brachytherapy
Item
2. prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy.
boolean
C1708063 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0194810 (UMLS CUI [2])
C1517033 (UMLS CUI [3])
C0006098 (UMLS CUI [4])
PSA measurement | Antiandrogen therapy | PSA Nadir | PSA measurement Following Quantity
Item
3. serum psa > 0.2 ng/dl following 8 months of androgen deprivation therapy or a nadir psa >0.2 ng/dl and at least 1 subsequent psa values at the same or higher level, if prior to 8 months.
boolean
C0201544 (UMLS CUI [1])
C0279492 (UMLS CUI [2])
C0138741 (UMLS CUI [3,1])
C1708760 (UMLS CUI [3,2])
C0201544 (UMLS CUI [4,1])
C0332282 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Serum testosterone measurement
Item
4. serum testosterone < 50 ng/ml.
boolean
C0428413 (UMLS CUI [1])
Neoplasm Metastasis Absent Bone scan
Item
5. no evidence of metastases on bone scan.
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
Neoplasm Metastasis Absent CT of abdomen | Neoplasm Metastasis Absent CT of Pelvis
Item
6. no evidence of metastases on ct scan of the abdomen and pelvis.
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0412620 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0412628 (UMLS CUI [2,3])
ECOG performance status
Item
7. ecog performance status < 2.
boolean
C1520224 (UMLS CUI [1])
Laboratory criteria | Absolute neutrophil count | Platelet Count measurement
Item
8. laboratory criteria for entry: absolute neutrophil count ≥ 1.2 k/cu mm, platelets ≥
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum
Item
100 k/cu mm, serum bilirubin ≤ upper limit of normal (uln), sgot and sgpt ≤ 1.5 times institutional uln if alkaline phosphatase ≤ uln, alkaline phosphatase ≤ 5 times uln if sgot and sgpt are ≤ uln, a serum creatinine ≤ 2 times institutional uln.
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Informed Consent
Item
9. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasms, Second Primary | Exception Skin carcinoma Treated
Item
1. a second active malignancy during the last 5 years, except adequately treated non-melanoma skin cancer.
boolean
C0085183 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Life Expectancy
Item
2. life expectancy < 3 months.
boolean
C0023671 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
3. grade 2 or higher peripheral neuropathy.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Investigational New Drugs
Item
4. prior investigational agent within the past 28 days.
boolean
C0013230 (UMLS CUI [1])
Antiandrogen therapy Initial | PSA decreased Percentage | Raised PSA
Item
5. less than a 10% decrease (or continued rise) in psa in response to initial androgen-deprivation therapy.
boolean
C0279492 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0178414 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0178415 (UMLS CUI [3])
Duration Since Antiandrogen therapy Initiation
Item
6. more than 12 months since initiation of androgen-deprivation therapy.
boolean
C0449238 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C0279492 (UMLS CUI [1,3])
C1704686 (UMLS CUI [1,4])
docetaxel
Item
7. prior docetaxel chemotherapy.
boolean
C0246415 (UMLS CUI [1])
Adrenal Cortex Hormones Started | Exception inhaled steroids | Exception topical steroids | CORTICOSTEROIDS FOR SYSTEMIC USE Dose Stable eligible
Item
8. patients recently (within 28 days) started on corticosteroids, with the exception of inhaled and topical steroids. patients on stable doses of systemic corticosteroids will be eligible.
boolean
C0001617 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2065041 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2064827 (UMLS CUI [3,2])
C3653708 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C1548635 (UMLS CUI [4,4])
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