ID

18939

Description

Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00084552

Link

https://clinicaltrials.gov/show/NCT00084552

Keywords

Versions (1)
  1. 11/25/16 11/25/16 -
Uploaded on

November 25, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00084552

English

Eligibility Prostate Cancer NCT00084552

1 forms  
Criteria
Description

Criteria

histologically confirmed adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
clinical stage t1b-t2c by palpation
Description

TNM clinical staging Palpation

Data type

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0030247
pretreatment prostate-specific antigen ≤ 20 ng/ml
Description

Prostate specific antigen measurement Pretreatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C3539075
gleason score ≤ 7
Description

Gleason score

Data type

boolean

Alias
UMLS CUI [1]
C3203027
suitable erectile function, defined as a response ≥ score 2 in question #1 of the international index of erectile function questionnaire
Description

erectile function Adequate International Index of Erectile Function Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C0234606
UMLS CUI [1,2]
C0205411
UMLS CUI [1,3]
C3641331
no clinical, radiographic, or pathologic evidence of nodal or distant metastatic disease
Description

Neoplasm Metastasis nodal | Neoplasm Metastasis Distant

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0443268
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0443203
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
not specified
Description

Unspecified

Data type

boolean

Alias
UMLS CUI [1]
C0205370
performance status
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
zubrod 0-1
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
life expectancy
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
not specified
Description

Unspecified

Data type

boolean

Alias
UMLS CUI [1]
C0205370
hematopoietic
Description

Function Hematopoietic

Data type

boolean

Alias
UMLS CUI [1,1]
C0031843
UMLS CUI [1,2]
C0229601
not specified
Description

Unspecified

Data type

boolean

Alias
UMLS CUI [1]
C0205370
hepatic
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
not specified
Description

Unspecified

Data type

boolean

Alias
UMLS CUI [1]
C0205370
renal
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
not specified
Description

Unspecified

Data type

boolean

Alias
UMLS CUI [1]
C0205370
other
Description

Clinical Trial Eligibility Criteria Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0205394
fertile patients must use effective contraception
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no other active malignancy within the past 5 years except nonmetastatic skin cancer or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma)
Description

Malignant Neoplasms | Skin carcinoma | Chronic Lymphocytic Leukemia Early stage | Small Cell Lymphoma Well Differentiated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3,1]
C0023434
UMLS CUI [3,2]
C2363430
UMLS CUI [4,1]
C0024303
UMLS CUI [4,2]
C0205615
no other medical condition that would preclude study participation
Description

Study Subject Participation Status Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C2828389
prior concurrent therapy:
Description

Therapeutic procedure Concurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205420
biologic therapy
Description

Biological treatment

Data type

boolean

Alias
UMLS CUI [1]
C1531518
not specified
Description

Unspecified

Data type

boolean

Alias
UMLS CUI [1]
C0205370
chemotherapy
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
not specified
Description

Unspecified

Data type

boolean

Alias
UMLS CUI [1]
C0205370
endocrine therapy
Description

Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
prior androgen-ablation therapy allowed provided total calculated duration ≤ 4 months
Description

androgen ablation Duration Calculated

Data type

boolean

Alias
UMLS CUI [1,1]
C1515985
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C1441506
radiotherapy
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
no prior pelvic radiotherapy
Description

Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
surgery
Description

Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0543467
no prior or planned radical prostate surgery
Description

Operation on prostate Radical | Operation on prostate Radical Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0194790
UMLS CUI [1,2]
C0439807
UMLS CUI [2,1]
C0194790
UMLS CUI [2,2]
C0439807
UMLS CUI [2,3]
C1301732
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Similar models

Eligibility Prostate Cancer NCT00084552

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
TNM clinical staging Palpation
Item
clinical stage t1b-t2c by palpation
boolean
C3258246 (UMLS CUI [1,1])
C0030247 (UMLS CUI [1,2])
Prostate specific antigen measurement Pretreatment
Item
pretreatment prostate-specific antigen ≤ 20 ng/ml
boolean
C0201544 (UMLS CUI [1,1])
C3539075 (UMLS CUI [1,2])
Gleason score
Item
gleason score ≤ 7
boolean
C3203027 (UMLS CUI [1])
erectile function Adequate International Index of Erectile Function Questionnaire
Item
suitable erectile function, defined as a response ≥ score 2 in question #1 of the international index of erectile function questionnaire
boolean
C0234606 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C3641331 (UMLS CUI [1,3])
Neoplasm Metastasis nodal | Neoplasm Metastasis Distant
Item
no clinical, radiographic, or pathologic evidence of nodal or distant metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0443268 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0443203 (UMLS CUI [2,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Unspecified
Item
not specified
boolean
C0205370 (UMLS CUI [1])
performance status
Item
performance status
boolean
C1518965 (UMLS CUI [1])
Zubrod Performance Status
Item
zubrod 0-1
boolean
C3714786 (UMLS CUI [1])
Life Expectancy
Item
life expectancy
boolean
C0023671 (UMLS CUI [1])
Unspecified
Item
not specified
boolean
C0205370 (UMLS CUI [1])
Function Hematopoietic
Item
hematopoietic
boolean
C0031843 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
Unspecified
Item
not specified
boolean
C0205370 (UMLS CUI [1])
Liver function
Item
hepatic
boolean
C0232741 (UMLS CUI [1])
Unspecified
Item
not specified
boolean
C0205370 (UMLS CUI [1])
Renal function
Item
renal
boolean
C0232804 (UMLS CUI [1])
Unspecified
Item
not specified
boolean
C0205370 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Other
Item
other
boolean
C1516637 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Malignant Neoplasms | Skin carcinoma | Chronic Lymphocytic Leukemia Early stage | Small Cell Lymphoma Well Differentiated
Item
no other active malignancy within the past 5 years except nonmetastatic skin cancer or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma)
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0023434 (UMLS CUI [3,1])
C2363430 (UMLS CUI [3,2])
C0024303 (UMLS CUI [4,1])
C0205615 (UMLS CUI [4,2])
Study Subject Participation Status Exclusion
Item
no other medical condition that would preclude study participation
boolean
C2348568 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Therapeutic procedure Concurrent
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
Biological treatment
Item
biologic therapy
boolean
C1531518 (UMLS CUI [1])
Unspecified
Item
not specified
boolean
C0205370 (UMLS CUI [1])
Chemotherapy
Item
chemotherapy
boolean
C0392920 (UMLS CUI [1])
Unspecified
Item
not specified
boolean
C0205370 (UMLS CUI [1])
Hormone Therapy
Item
endocrine therapy
boolean
C0279025 (UMLS CUI [1])
androgen ablation Duration Calculated
Item
prior androgen-ablation therapy allowed provided total calculated duration ≤ 4 months
boolean
C1515985 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1441506 (UMLS CUI [1,3])
Therapeutic radiology procedure
Item
radiotherapy
boolean
C1522449 (UMLS CUI [1])
Radiotherapy to pelvis
Item
no prior pelvic radiotherapy
boolean
C1536155 (UMLS CUI [1])
Operative Surgical Procedures
Item
surgery
boolean
C0543467 (UMLS CUI [1])
Operation on prostate Radical | Operation on prostate Radical Planned
Item
no prior or planned radical prostate surgery
boolean
C0194790 (UMLS CUI [1,1])
C0439807 (UMLS CUI [1,2])
C0194790 (UMLS CUI [2,1])
C0439807 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
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