ID

31586

Beschreibung

Phase II Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00714376

Link

https://clinicaltrials.gov/show/NCT00714376

Stichworte

Versionen (1)
  1. 08.09.18 08.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. September 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00714376

Englisch

Eligibility Prostate Cancer NCT00714376

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of prostate adenocarcinoma on a radical prostatectomy.
Beschreibung

Adenocarcinoma of prostate | Radical prostatectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2]
C0194810
2. prior radical prostatectomy within less than 2 years from the time of first psa rise.
Beschreibung

Radical prostatectomy Previous | Raised prostate specific antigen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0178415
3. demonstration of biochemical recurrence based on a psa detectable >0.03 less than 24 months after radical prostatectomy and confirmed on 2 additional tests.
Beschreibung

Biochemical recurrence | Prostate specific antigen measurement Post Radical prostatectomy | Tests Additional Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C2985506
UMLS CUI [2,1]
C0201544
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0194810
UMLS CUI [3,1]
C0022885
UMLS CUI [3,2]
C1524062
UMLS CUI [3,3]
C1265611
4. psa doubling time over three values must be <= 9 months for psa >=0.4 and psa <=10. if psa is >10, there is no need for psa doubling time.
Beschreibung

Prostate-Specific Antigen Doubling Time | Prostate specific antigen measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C2986483
UMLS CUI [2]
C0201544
5. karnofsky performance status (kps) >=70%
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
6. adequate organ function as defined by hemogram with haemoglobin >8.0, platelet >100 000, white blood cell >3,500, creatinine clearance >=60 cc/min and normal liver function tests.
Beschreibung

Organ function | Hemogram | Hemoglobin measurement | Platelet Count measurement | White Blood Cell Count procedure | Creatinine clearance measurement | Liver function tests normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0200631
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0023508
UMLS CUI [6]
C0373595
UMLS CUI [7]
C0438235
7. neoadjuvant hormone therapy prior to radical prostatectomy is allowed provided that the total duration of therapy did not exceed 6 months.
Beschreibung

Hormone Therapy Neoadjuvant prior to Radical prostatectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0194810
8. subjects must have signed an informed consent document stating that they understand the investigational or nature of the proposed treatment.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
9. subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinical significant cardiac disease (new york heart association class iii/iv), or severe debilitating pulmonary disease.
Beschreibung

Heart Disease New York Heart Association Classification | Lung disease Debilitation Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0742985
UMLS CUI [2,3]
C0205082
2. uncontrolled serious active infection.
Beschreibung

Communicable Disease Serious Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
3. anticipated duration of life less than 2 years.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
4. less than 5-year history of successful treatment for other cancers or concurrent active non prostate cancer other than non melanoma dermatologic tumors and non-muscle invasive bladder tumors.
Beschreibung

Successful treatment Cancer Other | Cancer Other Except Prostate carcinoma | Exception Skin carcinoma | Exception Superficial bladder cancer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0600139
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1336527
5. peripheral neuropathy >=2 grade 2
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
6. concurrent experimental treatment or involvement in other clinical trials involving drugs.
Beschreibung

Therapies, Investigational | Involvement with Clinical Trials | Involvement with Pharmaceutical Preparations

Datentyp

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0008976
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0013227
7. other severe acute or chronic medical conditions including psychiatric diseases or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety.
Beschreibung

Medical condition Severe Requirement Investigation | Medical condition chronic Requirement Investigation | Mental disorders Requirement Investigation | Laboratory test result abnormal Requirement Investigation | Investigation At risk Patient safety

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0683933
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0683933
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0683933
UMLS CUI [4,1]
C0438215
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0683933
UMLS CUI [5,1]
C0683933
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C1113679
8. subjects who participated in another clinical study/received investigational product within 30 days of screening for this study.
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00714376

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | Radical prostatectomy
Item
1. diagnosis of prostate adenocarcinoma on a radical prostatectomy.
boolean
C0007112 (UMLS CUI [1])
C0194810 (UMLS CUI [2])
Radical prostatectomy Previous | Raised prostate specific antigen
Item
2. prior radical prostatectomy within less than 2 years from the time of first psa rise.
boolean
C0194810 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2])
Biochemical recurrence | Prostate specific antigen measurement Post Radical prostatectomy | Tests Additional Quantity
Item
3. demonstration of biochemical recurrence based on a psa detectable >0.03 less than 24 months after radical prostatectomy and confirmed on 2 additional tests.
boolean
C2985506 (UMLS CUI [1])
C0201544 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0194810 (UMLS CUI [2,3])
C0022885 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Prostate-Specific Antigen Doubling Time | Prostate specific antigen measurement
Item
4. psa doubling time over three values must be <= 9 months for psa >=0.4 and psa <=10. if psa is >10, there is no need for psa doubling time.
boolean
C0138741 (UMLS CUI [1,1])
C2986483 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
Karnofsky Performance Status
Item
5. karnofsky performance status (kps) >=70%
boolean
C0206065 (UMLS CUI [1])
Organ function | Hemogram | Hemoglobin measurement | Platelet Count measurement | White Blood Cell Count procedure | Creatinine clearance measurement | Liver function tests normal
Item
6. adequate organ function as defined by hemogram with haemoglobin >8.0, platelet >100 000, white blood cell >3,500, creatinine clearance >=60 cc/min and normal liver function tests.
boolean
C0678852 (UMLS CUI [1])
C0200631 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
C0373595 (UMLS CUI [6])
C0438235 (UMLS CUI [7])
Hormone Therapy Neoadjuvant prior to Radical prostatectomy
Item
7. neoadjuvant hormone therapy prior to radical prostatectomy is allowed provided that the total duration of therapy did not exceed 6 months.
boolean
C0279025 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0194810 (UMLS CUI [1,4])
Informed Consent
Item
8. subjects must have signed an informed consent document stating that they understand the investigational or nature of the proposed treatment.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
9. subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Disease New York Heart Association Classification | Lung disease Debilitation Severe
Item
1. clinical significant cardiac disease (new york heart association class iii/iv), or severe debilitating pulmonary disease.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0742985 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Communicable Disease Serious Uncontrolled
Item
2. uncontrolled serious active infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Life Expectancy
Item
3. anticipated duration of life less than 2 years.
boolean
C0023671 (UMLS CUI [1])
Successful treatment Cancer Other | Cancer Other Except Prostate carcinoma | Exception Skin carcinoma | Exception Superficial bladder cancer
Item
4. less than 5-year history of successful treatment for other cancers or concurrent active non prostate cancer other than non melanoma dermatologic tumors and non-muscle invasive bladder tumors.
boolean
C0521982 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1707251 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1336527 (UMLS CUI [4,2])
Peripheral Neuropathy CTCAE Grades
Item
5. peripheral neuropathy >=2 grade 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Therapies, Investigational | Involvement with Clinical Trials | Involvement with Pharmaceutical Preparations
Item
6. concurrent experimental treatment or involvement in other clinical trials involving drugs.
boolean
C0949266 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
Medical condition Severe Requirement Investigation | Medical condition chronic Requirement Investigation | Mental disorders Requirement Investigation | Laboratory test result abnormal Requirement Investigation | Investigation At risk Patient safety
Item
7. other severe acute or chronic medical conditions including psychiatric diseases or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0683933 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0683933 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0683933 (UMLS CUI [3,3])
C0438215 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0683933 (UMLS CUI [4,3])
C0683933 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
Study Subject Participation Status | Investigational New Drugs
Item
8. subjects who participated in another clinical study/received investigational product within 30 days of screening for this study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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