ID

19062

Description

Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX; ODM derived from: https://clinicaltrials.gov/show/NCT00590213

Link

https://clinicaltrials.gov/show/NCT00590213

Keywords

Versions (1)
  1. 12/2/16 12/2/16 -
Uploaded on

December 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00590213

English

Eligibility Prostate Cancer NCT00590213

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males patients aged 18 years or over on entry into the trial
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
patients who have non-metastatic cancer that is confirmed by histology or cytology. this primary treatment should have been completed in the last 8 weeks
Description

Prostate carcinoma | First line treatment Complete

Data type

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0205197
the stage should be t1b/t1c/t2/t3/t4 any n category
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
paitents must have given written, fully informed consent to participate in the trial prior to any trial specific assessments being made
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
be able and prepared to comply with trial procedures and restrictions
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
have a life expectancy greater than 2 years
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any known sensitivity to radiation therapy or any conditions which in the investigator's opinion may lead to radiation sensitivity
Description

Hypersensitivity Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1522449
patients with any concurrent malignancy (except for basal cell or to-2 no mo squamous cell carcinoma of the skin). history of previous malignancy or treatment for any cancer in the past 5 years
Description

Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin | cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
UMLS CUI [4]
C0920425
previous history of mastectomy including a webster operation or radiation therapy to the chest area
Description

Mastectomy | Mastectomy for gynecomastia | Therapeutic radiology procedure Chest

Data type

boolean

Alias
UMLS CUI [1]
C0024881
UMLS CUI [2]
C0473513
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0817096
any previous treatment with surgical or medical castration, anti-androgens, monotherapy or oestrogen therapy at any time
Description

Male Castration | Medical Castration | Androgen Antagonists | Therapeutic procedure | Oestrogen therapy

Data type

boolean

Alias
UMLS CUI [1]
C0007347
UMLS CUI [2]
C1513054
UMLS CUI [3]
C0002842
UMLS CUI [4]
C0087111
UMLS CUI [5]
C0279494
any evidence of pre-existing gynaecomastia or breast pain
Description

Gynecomastia Pre-existing Evidence of | Mastodynia Pre-existing Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0018418
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0332120
UMLS CUI [2,1]
C0024902
UMLS CUI [2,2]
C2347662
UMLS CUI [2,3]
C0332120
patients with history or presence of testicular abnormalities (as casodex can potentially aggravate testicular tumours)
Description

Abnormality Testicular | Testicular Neoplasms Exacerbated Due to Casodex

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205070
UMLS CUI [2,1]
C0039590
UMLS CUI [2,2]
C1444749
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0591237
patients with any concurrent disease or condition that in the opinion of the treating physician, would constitute a hazard for participation in this study or may interfere with the patient's ability to comply with the scheduled visits and assessments. this includes patients whose physical build would prevent reasonable assessment of gynaecomastia
Description

Comorbidity At risk Study Subject Participation Status | Condition At risk Study Subject Participation Status | Comorbidity Interferes with Protocol Compliance | Condition Interferes with Protocol Compliance | Body build Preventing Assessment Gynecomastia

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C1318474
UMLS CUI [5,2]
C1292733
UMLS CUI [5,3]
C1516048
UMLS CUI [5,4]
C0018418
liver disease (bilirubin greater than 2.0mg/dl; ast/alt greater than 2 times the upper limit or normal)
Description

Liver disease | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
patients taking the following drugs; terfenadine, cisapride, astemizole, cyclosporin, and warfarin are excluded from the trial due to the possibility of drug interaction
Description

Pharmaceutical Preparations Drug Interactions Possible | Terfenadine | Cisapride | Astemizole | Cyclosporine | Warfarin

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C0332149
UMLS CUI [2]
C0085173
UMLS CUI [3]
C0072916
UMLS CUI [4]
C0085170
UMLS CUI [5]
C0010592
UMLS CUI [6]
C0043031
patients with a known history of alcohol abuse
Description

Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
concurrent treatment with any druges known to have high potential for causing gynaecomastia or breast pain, eg.spironolactone, steroid therapy, cimetidine and neuroleptic agents.
Description

Pharmacotherapy Causing Gynecomastia | Pharmacotherapy Causing Mastodynia | Spironolactone | Steroid therapy | Cimetidine | Antipsychotic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0018418
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0024902
UMLS CUI [3]
C0037982
UMLS CUI [4]
C0149783
UMLS CUI [5]
C0008783
UMLS CUI [6]
C0040615
treatment with a new chemical entity within the previous 4 months or current participation in another clinical trial involving an investigational product
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
patients considered by the investigator to be at risk of transmitting any infection through the body or other body fluids, including acquired immue dificiency syndrome (aids) other sexually transmitted diseases or hepatitis
Description

disease transmission Risk | Acquired Immunodeficiency Syndrome | Sexually Transmitted Diseases | Hepatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0242781
UMLS CUI [1,2]
C0035647
UMLS CUI [2]
C0001175
UMLS CUI [3]
C0036916
UMLS CUI [4]
C0019158
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Similar models

Eligibility Prostate Cancer NCT00590213

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
males patients aged 18 years or over on entry into the trial
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Prostate carcinoma | First line treatment Complete
Item
patients who have non-metastatic cancer that is confirmed by histology or cytology. this primary treatment should have been completed in the last 8 weeks
boolean
C0600139 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
TNM clinical staging
Item
the stage should be t1b/t1c/t2/t3/t4 any n category
boolean
C3258246 (UMLS CUI [1])
Informed Consent
Item
paitents must have given written, fully informed consent to participate in the trial prior to any trial specific assessments being made
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
be able and prepared to comply with trial procedures and restrictions
boolean
C0525058 (UMLS CUI [1])
Life Expectancy
Item
have a life expectancy greater than 2 years
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Therapeutic radiology procedure
Item
any known sensitivity to radiation therapy or any conditions which in the investigator's opinion may lead to radiation sensitivity
boolean
C0020517 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin | cancer treatment
Item
patients with any concurrent malignancy (except for basal cell or to-2 no mo squamous cell carcinoma of the skin). history of previous malignancy or treatment for any cancer in the past 5 years
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0920425 (UMLS CUI [4])
Mastectomy | Mastectomy for gynecomastia | Therapeutic radiology procedure Chest
Item
previous history of mastectomy including a webster operation or radiation therapy to the chest area
boolean
C0024881 (UMLS CUI [1])
C0473513 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0817096 (UMLS CUI [3,2])
Male Castration | Medical Castration | Androgen Antagonists | Therapeutic procedure | Oestrogen therapy
Item
any previous treatment with surgical or medical castration, anti-androgens, monotherapy or oestrogen therapy at any time
boolean
C0007347 (UMLS CUI [1])
C1513054 (UMLS CUI [2])
C0002842 (UMLS CUI [3])
C0087111 (UMLS CUI [4])
C0279494 (UMLS CUI [5])
Gynecomastia Pre-existing Evidence of | Mastodynia Pre-existing Evidence of
Item
any evidence of pre-existing gynaecomastia or breast pain
boolean
C0018418 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0024902 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C0332120 (UMLS CUI [2,3])
Abnormality Testicular | Testicular Neoplasms Exacerbated Due to Casodex
Item
patients with history or presence of testicular abnormalities (as casodex can potentially aggravate testicular tumours)
boolean
C1704258 (UMLS CUI [1,1])
C0205070 (UMLS CUI [1,2])
C0039590 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0591237 (UMLS CUI [2,4])
Comorbidity At risk Study Subject Participation Status | Condition At risk Study Subject Participation Status | Comorbidity Interferes with Protocol Compliance | Condition Interferes with Protocol Compliance | Body build Preventing Assessment Gynecomastia
Item
patients with any concurrent disease or condition that in the opinion of the treating physician, would constitute a hazard for participation in this study or may interfere with the patient's ability to comply with the scheduled visits and assessments. this includes patients whose physical build would prevent reasonable assessment of gynaecomastia
boolean
C0009488 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C1318474 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C1516048 (UMLS CUI [5,3])
C0018418 (UMLS CUI [5,4])
Liver disease | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
liver disease (bilirubin greater than 2.0mg/dl; ast/alt greater than 2 times the upper limit or normal)
boolean
C0023895 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Pharmaceutical Preparations Drug Interactions Possible | Terfenadine | Cisapride | Astemizole | Cyclosporine | Warfarin
Item
patients taking the following drugs; terfenadine, cisapride, astemizole, cyclosporin, and warfarin are excluded from the trial due to the possibility of drug interaction
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
C0085173 (UMLS CUI [2])
C0072916 (UMLS CUI [3])
C0085170 (UMLS CUI [4])
C0010592 (UMLS CUI [5])
C0043031 (UMLS CUI [6])
Alcohol abuse
Item
patients with a known history of alcohol abuse
boolean
C0085762 (UMLS CUI [1])
Pharmacotherapy Causing Gynecomastia | Pharmacotherapy Causing Mastodynia | Spironolactone | Steroid therapy | Cimetidine | Antipsychotic Agents
Item
concurrent treatment with any druges known to have high potential for causing gynaecomastia or breast pain, eg.spironolactone, steroid therapy, cimetidine and neuroleptic agents.
boolean
C0013216 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0018418 (UMLS CUI [1,3])
C0013216 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0024902 (UMLS CUI [2,3])
C0037982 (UMLS CUI [3])
C0149783 (UMLS CUI [4])
C0008783 (UMLS CUI [5])
C0040615 (UMLS CUI [6])
Study Subject Participation Status | Investigational New Drugs
Item
treatment with a new chemical entity within the previous 4 months or current participation in another clinical trial involving an investigational product
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
disease transmission Risk | Acquired Immunodeficiency Syndrome | Sexually Transmitted Diseases | Hepatitis
Item
patients considered by the investigator to be at risk of transmitting any infection through the body or other body fluids, including acquired immue dificiency syndrome (aids) other sexually transmitted diseases or hepatitis
boolean
C0242781 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0001175 (UMLS CUI [2])
C0036916 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
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