ID

22834

Beschreibung

Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00477087

Link

https://clinicaltrials.gov/show/NCT00477087

Stichworte

Versionen (1)
  1. 12.06.17 12.06.17 -
Hochgeladen am

12. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00477087

Englisch

Eligibility Prostatic Neoplasms NCT00477087

1 Formulare  
Criteria
Beschreibung

Criteria

must be of age 18 years or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
must have histologically confirmed adenocarcinoma of the prostate
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
must have hormone-refractory prostate cancer
Beschreibung

Hormone refractory prostate cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C1328504
must have failed first-line docetaxel-containing regimen
Beschreibung

docetaxel | First line treatment failed

Datentyp

boolean

Alias
UMLS CUI [1]
C0246415
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0231175
must not have had any prior immunotherapy including, but not limited to, vaccines and gm-csf
Beschreibung

Immunotherapy Absent | Vaccines Absent | GM-CSF Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0079460
UMLS CUI [3,2]
C0332197
minimum psa > 5mg/dl, and rising according to the psa consensus criteria (i.e. progressive disease after androgen deprivation and during first-line docetaxel-based chemotherapy)
Beschreibung

Prostate-Specific Antigen Minimum | Raised prostate specific antigen | Progressive Disease Post Androgen suppression | docetaxel | First line treatment Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C1524031
UMLS CUI [2]
C0178415
UMLS CUI [3,1]
C1335499
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1515985
UMLS CUI [4]
C0246415
UMLS CUI [5,1]
C1708063
UMLS CUI [5,2]
C0392920
kps > 60%
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
life expectancy of greater than 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
exclusion criteria:- concomitant hormonal therapy
Beschreibung

Exclusion Criteria | Hormone Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0279025
noncompliance
Beschreibung

Non-compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0457432
use of herbal products known to decrease psa levels
Beschreibung

Medicinal Herbs | Prostatic specific antigen decreased

Datentyp

boolean

Alias
UMLS CUI [1]
C0025125
UMLS CUI [2]
C0178414
use of supplements or complementary medicines, except for conventional multivitamin supplements, selenium, lycopene, soy supplements, vitamin e
Beschreibung

Supplement Use of | Pharmaceutical Preparations Additional | Multivitamin preparation Supplement conventional | Selenium | lycopene | Soy | Vitamin E

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348609
UMLS CUI [1,2]
C1524063
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1524062
UMLS CUI [3,1]
C0301532
UMLS CUI [3,2]
C2348609
UMLS CUI [3,3]
C0439858
UMLS CUI [4]
C0521939
UMLS CUI [5]
C0065331
UMLS CUI [6]
C2756587
UMLS CUI [7]
C0042874
initiation of bisphosphonates within one month prior to enrollment or throughout the study
Beschreibung

Diphosphonates

Datentyp

boolean

Alias
UMLS CUI [1]
C0012544
any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment
Beschreibung

Radiopharmaceuticals | Strontium | Samarium

Datentyp

boolean

Alias
UMLS CUI [1]
C0182638
UMLS CUI [2]
C0038467
UMLS CUI [3]
C0036147
major surgery or radiation therapy completed <4 weeks prior to enrollment
Beschreibung

major surgery | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C1522449
any concomitant second malignancy other than non-melanoma skin cancer
Beschreibung

Neoplasms, Second | Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2]
C0699893
any concomitant serious infection or nonmalignant medical illness
Beschreibung

Communicable Disease Serious | Illness Non-Malignant Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C1518371
UMLS CUI [2,3]
C0205404
anc < 1,500/µl, platelet count <100,000/µl, hemoglobin < 8 mg/dl
Beschreibung

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
total bilirubin greater than 1.5 x ulrr
Beschreibung

Elevated total bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C0741494
alt or ast greater than 2.5 x ulrr if no demonstrable liver metastases or greater than 5.0 x ulrr in presence of liver metastases
Beschreibung

Alanine aminotransferase increased | Aspartate aminotransferase increased | Secondary malignant neoplasm of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0494165
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Ähnliche Modelle

Eligibility Prostatic Neoplasms NCT00477087

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age
Item
must be of age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
must have histologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Hormone refractory prostate cancer
Item
must have hormone-refractory prostate cancer
boolean
C1328504 (UMLS CUI [1])
docetaxel | First line treatment failed
Item
must have failed first-line docetaxel-containing regimen
boolean
C0246415 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Immunotherapy Absent | Vaccines Absent | GM-CSF Absent
Item
must not have had any prior immunotherapy including, but not limited to, vaccines and gm-csf
boolean
C0021083 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0079460 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Prostate-Specific Antigen Minimum | Raised prostate specific antigen | Progressive Disease Post Androgen suppression | docetaxel | First line treatment Chemotherapy
Item
minimum psa > 5mg/dl, and rising according to the psa consensus criteria (i.e. progressive disease after androgen deprivation and during first-line docetaxel-based chemotherapy)
boolean
C0138741 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2])
C1335499 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1515985 (UMLS CUI [3,3])
C0246415 (UMLS CUI [4])
C1708063 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
Karnofsky Performance Status
Item
kps > 60%
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 6 months
boolean
C0023671 (UMLS CUI [1])
Exclusion Criteria | Hormone Therapy
Item
exclusion criteria:- concomitant hormonal therapy
boolean
C0680251 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Non-compliance
Item
noncompliance
boolean
C0457432 (UMLS CUI [1])
Medicinal Herbs | Prostatic specific antigen decreased
Item
use of herbal products known to decrease psa levels
boolean
C0025125 (UMLS CUI [1])
C0178414 (UMLS CUI [2])
Supplement Use of | Pharmaceutical Preparations Additional | Multivitamin preparation Supplement conventional | Selenium | lycopene | Soy | Vitamin E
Item
use of supplements or complementary medicines, except for conventional multivitamin supplements, selenium, lycopene, soy supplements, vitamin e
boolean
C2348609 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0301532 (UMLS CUI [3,1])
C2348609 (UMLS CUI [3,2])
C0439858 (UMLS CUI [3,3])
C0521939 (UMLS CUI [4])
C0065331 (UMLS CUI [5])
C2756587 (UMLS CUI [6])
C0042874 (UMLS CUI [7])
Diphosphonates
Item
initiation of bisphosphonates within one month prior to enrollment or throughout the study
boolean
C0012544 (UMLS CUI [1])
Radiopharmaceuticals | Strontium | Samarium
Item
any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment
boolean
C0182638 (UMLS CUI [1])
C0038467 (UMLS CUI [2])
C0036147 (UMLS CUI [3])
major surgery | Therapeutic radiology procedure
Item
major surgery or radiation therapy completed <4 weeks prior to enrollment
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Neoplasms, Second | Skin carcinoma
Item
any concomitant second malignancy other than non-melanoma skin cancer
boolean
C0085183 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
Communicable Disease Serious | Illness Non-Malignant Serious
Item
any concomitant serious infection or nonmalignant medical illness
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C1518371 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
anc < 1,500/µl, platelet count <100,000/µl, hemoglobin < 8 mg/dl
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Elevated total bilirubin
Item
total bilirubin greater than 1.5 x ulrr
boolean
C0741494 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Secondary malignant neoplasm of liver
Item
alt or ast greater than 2.5 x ulrr if no demonstrable liver metastases or greater than 5.0 x ulrr in presence of liver metastases
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
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