ID

25063

Beschreibung

Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury; ODM derived from: https://clinicaltrials.gov/show/NCT00580970

Link

https://clinicaltrials.gov/show/NCT00580970

Stichworte

Versionen (1)
  1. 25.08.17 25.08.17 -
Hochgeladen am

25. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00580970

Englisch

Eligibility Prostate Cancer NCT00580970

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
planned treatment with radiation therapy to include external beam and/or brachytherapy with curative intent (total dose ≥60 gy). a portion of the rectum must receive at least 60 gy.
Beschreibung

Therapeutic radiology procedure Planned | External beam radiotherapy Curative Dose | Brachytherapy Curative Dose | Radiotherapy to rectum Portion Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0419095
UMLS CUI [2,2]
C1276305
UMLS CUI [2,3]
C0178602
UMLS CUI [3,1]
C0006098
UMLS CUI [3,2]
C1276305
UMLS CUI [3,3]
C0178602
UMLS CUI [4,1]
C3888853
UMLS CUI [4,2]
C0449719
UMLS CUI [4,3]
C0178602
age at least 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status (kps) ≥ 70
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
no history of prior radiotherapy to the prostate or rectum
Beschreibung

Radiotherapy to prostate Previous Absent | Radiotherapy to rectum Previous Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948317
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3888853
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0332197
history of prior malignancy, if likely to live at least 4 years, is acceptable.
Beschreibung

Malignant Neoplasms | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0023671
no evidence of distant metastases
Beschreibung

Distant metastasis Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0332197
patients may be taking an hmg-coa-reductase inhibitor, but to be eligible, they must be able to be changed to lovastatin 20 mg/day, with the permission of their prescribing physician.
Beschreibung

HMG-CoA Reductase Inhibitor | Lovastatin U/day

Datentyp

boolean

Alias
UMLS CUI [1]
C0360714
UMLS CUI [2,1]
C0024027
UMLS CUI [2,2]
C0456683
creatine kinase < 5 times upper normal limit
Beschreibung

Creatine kinase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201973
sufficient renal function defined as calculated creatinine clearance ≥ 30ml/min
Beschreibung

Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C2711451
transaminases < 3 times upper normal limit
Beschreibung

Transaminases

Datentyp

boolean

Alias
UMLS CUI [1]
C0002594
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
planned abdomino-perineal resection after radiotherapy
Beschreibung

Abdominoperineal resection Planned | Therapeutic radiology procedure Status post

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2004459
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0231290
contraindication to an hmg-coa-reductase inhibitor
Beschreibung

Medical contraindication HMG-CoA Reductase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0360714
major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
Beschreibung

Illness Major Preventing Treatment completion | Mental disorder Major Preventing Treatment completion | Illness Major Interferes with Follow-up | Mental disorder Major Interferes with Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0580352
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0580352
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C3274571
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0205164
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C3274571
currently taking an inhibitor of cytochrome p450 3a4
Beschreibung

Cytochrome P450 3A4 Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C2962753
active liver or muscle disease
Beschreibung

Liver disease | Myopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0026848
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00580970

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Therapeutic radiology procedure Planned | External beam radiotherapy Curative Dose | Brachytherapy Curative Dose | Radiotherapy to rectum Portion Dose
Item
planned treatment with radiation therapy to include external beam and/or brachytherapy with curative intent (total dose ≥60 gy). a portion of the rectum must receive at least 60 gy.
boolean
C1522449 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0419095 (UMLS CUI [2,1])
C1276305 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0006098 (UMLS CUI [3,1])
C1276305 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C3888853 (UMLS CUI [4,1])
C0449719 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
Age
Item
age at least 18 years
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status (kps) ≥ 70
boolean
C0206065 (UMLS CUI [1])
Radiotherapy to prostate Previous Absent | Radiotherapy to rectum Previous Absent
Item
no history of prior radiotherapy to the prostate or rectum
boolean
C0948317 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3888853 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Malignant Neoplasms | Life Expectancy
Item
history of prior malignancy, if likely to live at least 4 years, is acceptable.
boolean
C0006826 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Distant metastasis Absent
Item
no evidence of distant metastases
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
HMG-CoA Reductase Inhibitor | Lovastatin U/day
Item
patients may be taking an hmg-coa-reductase inhibitor, but to be eligible, they must be able to be changed to lovastatin 20 mg/day, with the permission of their prescribing physician.
boolean
C0360714 (UMLS CUI [1])
C0024027 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Creatine kinase measurement
Item
creatine kinase < 5 times upper normal limit
boolean
C0201973 (UMLS CUI [1])
Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
sufficient renal function defined as calculated creatinine clearance ≥ 30ml/min
boolean
C0232804 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Transaminases
Item
transaminases < 3 times upper normal limit
boolean
C0002594 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Abdominoperineal resection Planned | Therapeutic radiology procedure Status post
Item
planned abdomino-perineal resection after radiotherapy
boolean
C2004459 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Medical contraindication HMG-CoA Reductase Inhibitors
Item
contraindication to an hmg-coa-reductase inhibitor
boolean
C1301624 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
Illness Major Preventing Treatment completion | Mental disorder Major Preventing Treatment completion | Illness Major Interferes with Follow-up | Mental disorder Major Interferes with Follow-up
Item
major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0580352 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0580352 (UMLS CUI [2,4])
C0221423 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C3274571 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C3274571 (UMLS CUI [4,4])
Cytochrome P450 3A4 Inhibitors
Item
currently taking an inhibitor of cytochrome p450 3a4
boolean
C2962753 (UMLS CUI [1])
Liver disease | Myopathy
Item
active liver or muscle disease
boolean
C0023895 (UMLS CUI [1])
C0026848 (UMLS CUI [2])
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