ID

25063

Descrição

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

Palavras-chave

Versões (1)
  1. 25/08/2017 25/08/2017 -
Transferido a

25 de agosto de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00580970

Inglês

Eligibility Prostate Cancer NCT00580970

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Adenocarcinoma of prostate

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Descrição

Age

Tipo de dados

boolean

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

Karnofsky Performance Status

Tipo de dados

boolean

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

Radiotherapy to prostate Previous Absent | Radiotherapy to rectum Previous Absent

Tipo de dados

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.
Descrição

Malignant Neoplasms | Life Expectancy

Tipo de dados

boolean

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

Distant metastasis Absent

Tipo de dados

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.
Descrição

HMG-CoA Reductase Inhibitor | Lovastatin U/day

Tipo de dados

boolean

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

Creatine kinase measurement

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

Transaminases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002594
Exclusion Criteria
Descrição

Exclusion Criteria

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

Abdominoperineal resection Planned | Therapeutic radiology procedure Status post

Tipo de dados

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
Descrição

Medical contraindication HMG-CoA Reductase Inhibitors

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Descrição

Cytochrome P450 3A4 Inhibitors

Tipo de dados

boolean

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

Liver disease | Myopathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0026848
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Similar models

Eligibility Prostate Cancer NCT00580970

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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