ID

29847

Beskrivning

A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00675545

Länk

https://clinicaltrials.gov/show/NCT00675545

Nyckelord

Versioner (1)
  1. 2018-04-24 2018-04-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hormone-Refractory Prostate Cancer NCT00675545

Engelsk

Eligibility Hormone-Refractory Prostate Cancer NCT00675545

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Adenocarcinoma of prostate

Datatyp

boolean

Alias
UMLS CUI [1]
C0007112
2. at the time of enrollment, patients must have evidence of metastatic disease, with either measurable disease per recist criteria or non- measurable disease (i.e. positive bones scan) and psa > 5 ng/mm3.
Beskrivning

Neoplasm Metastasis | Measurable Disease | Disease Non-Measurable | Bone scan Positive | Prostate specific antigen measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C1513041
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1518373
UMLS CUI [4,1]
C0203668
UMLS CUI [4,2]
C1514241
UMLS CUI [5]
C0201544
3. disease progression following androgen deprivation therapy.
Beskrivning

Disease Progression Post Antiandrogen therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0279492
4. progression is defined according to the psa working group criteria (see 6.1.3 and 6.3).
Beskrivning

Disease Progression Definition

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C1704788
5. serum testosterone levels < 50 ng/mm3 (unless surgically castrate). patients must continue androgen deprivation with an lhrh analogue if they have not undergone orchiectomy.
Beskrivning

Serum testosterone measurement | Exception Castration | Androgen suppression | LHRH Analogue | Orchiectomy Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0428413
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007347
UMLS CUI [3]
C1515985
UMLS CUI [4,1]
C0023610
UMLS CUI [4,2]
C0243071
UMLS CUI [5,1]
C0029189
UMLS CUI [5,2]
C0332197
6. no use of an antiandrogen for at least 4 weeks.
Beskrivning

Androgen Antagonists Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002842
UMLS CUI [1,2]
C0332197
7. have not been treated with chemotherapy before.
Beskrivning

Prior Chemotherapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
8. ecog performance status of <= 2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
9. laboratory criteria for entry:
Beskrivning

Laboratory criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
white blood cell (wbc) => 3000/mm3
Beskrivning

White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
platelets => 100,000/mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
ast < 2.5 x upper limit of normal
Beskrivning

Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
calculated cct of => 40 ml/min
Beskrivning

Other Coding

Datatyp

boolean

Alias
UMLS CUI [1]
C3846158
10. signed informed consent form.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
11. age: 30 years old and above
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. significant peripheral neuropathy defined as grade 2 or higher.
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

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

Teleradiotherapy | Radiopharmaceutical therapy | Strontium | Samarium

Datatyp

boolean

Alias
UMLS CUI [1]
C0419095
UMLS CUI [2]
C2094663
UMLS CUI [3]
C0038467
UMLS CUI [4]
C0036147
3. concomitant chemotherapy or investigational agents.
Beskrivning

Chemotherapy | Investigational New Drugs

Datatyp

boolean

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

Eligibility Hormone-Refractory Prostate Cancer NCT00675545

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
1. histologically confirmed adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
Neoplasm Metastasis | Measurable Disease | Disease Non-Measurable | Bone scan Positive | Prostate specific antigen measurement
Item
2. at the time of enrollment, patients must have evidence of metastatic disease, with either measurable disease per recist criteria or non- measurable disease (i.e. positive bones scan) and psa > 5 ng/mm3.
boolean
C0027627 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C1518373 (UMLS CUI [3,2])
C0203668 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0201544 (UMLS CUI [5])
Disease Progression Post Antiandrogen therapy
Item
3. disease progression following androgen deprivation therapy.
boolean
C0242656 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0279492 (UMLS CUI [1,3])
Disease Progression Definition
Item
4. progression is defined according to the psa working group criteria (see 6.1.3 and 6.3).
boolean
C0242656 (UMLS CUI [1,1])
C1704788 (UMLS CUI [1,2])
Serum testosterone measurement | Exception Castration | Androgen suppression | LHRH Analogue | Orchiectomy Absent
Item
5. serum testosterone levels < 50 ng/mm3 (unless surgically castrate). patients must continue androgen deprivation with an lhrh analogue if they have not undergone orchiectomy.
boolean
C0428413 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007347 (UMLS CUI [2,2])
C1515985 (UMLS CUI [3])
C0023610 (UMLS CUI [4,1])
C0243071 (UMLS CUI [4,2])
C0029189 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Androgen Antagonists Absent
Item
6. no use of an antiandrogen for at least 4 weeks.
boolean
C0002842 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Prior Chemotherapy Absent
Item
7. have not been treated with chemotherapy before.
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
ECOG performance status
Item
8. ecog performance status of <= 2.
boolean
C1520224 (UMLS CUI [1])
Laboratory criteria
Item
9. laboratory criteria for entry:
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
White Blood Cell Count procedure
Item
white blood cell (wbc) => 3000/mm3
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
platelets => 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
ast < 2.5 x upper limit of normal
boolean
C0201899 (UMLS CUI [1])
Other Coding
Item
calculated cct of => 40 ml/min
boolean
C3846158 (UMLS CUI [1])
Informed Consent
Item
10. signed informed consent form.
boolean
C0021430 (UMLS CUI [1])
Age
Item
11. age: 30 years old and above
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Peripheral Neuropathy CTCAE Grades
Item
1. significant peripheral neuropathy defined as grade 2 or higher.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Teleradiotherapy | Radiopharmaceutical therapy | Strontium | Samarium
Item
2. within 4 weeks since completing external beam radiotherapy or 8 weeks since completing radiopharmaceutical therapy (strontium, samarium).
boolean
C0419095 (UMLS CUI [1])
C2094663 (UMLS CUI [2])
C0038467 (UMLS CUI [3])
C0036147 (UMLS CUI [4])
Chemotherapy | Investigational New Drugs
Item
3. concomitant chemotherapy or investigational agents.
boolean
C0392920 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Tillbaka till toppen 

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