ID

17231

Beschrijving

External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00388804

Link

https://clinicaltrials.gov/show/NCT00388804

Trefwoorden

Versies (1)
  1. 01-09-16 01-09-16 -
Geüploaded op

1 september 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00388804

Engels

Eligibility Prostate Cancer NCT00388804

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. biopsy proven prostate cancer within last 12 months. pathology must be reviewed at m.d. anderson cancer center (mdacc).
Beschrijving

prostate cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0600139
2. 1992 american joint committee on cancer (ajcc) clinical stage t1c-2b on digital rectal exam with biopsy gleason sum of 7 and prostate-specific antigen (psa) < 20 ng/ml (i.e. psa 19.99 ng/ml or less)
Beschrijving

AJCC tumor staging; Gleason score; PSA

Datatype

boolean

Alias
UMLS CUI [1]
C0441915
UMLS CUI [2]
C0332326
UMLS CUI [3]
C0201544
3. 1992 ajcc clinical stage t2b on physical exam with biopsy gleason sum of 7 or less and/or psa < 20 ng/ml
Beschrijving

AJCC tumor staging; Gleason score; PSA

Datatype

boolean

Alias
UMLS CUI [1]
C0441915
UMLS CUI [2]
C0332326
UMLS CUI [3]
C0201544
4. 1992 ajcc clinical stage t1c-2b on digital rectal exam with biopsy gleason sum of 7 or less and psa > 10 but less than 20 ng/ml (i.e. 10.01-19.99 ng/ml). psa used for protocol eligibility should be obtained within 30 days of protocol enrollment.
Beschrijving

AJCC tumor staging; Gleason score; PSA

Datatype

boolean

Alias
UMLS CUI [1]
C0441915
UMLS CUI [2]
C0332326
UMLS CUI [3]
C0201544
5. no evidence of metastatic disease on bone scan within 3 months of study enrollment.
Beschrijving

metastatic disease on bone scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0203668
6. no evidence of metastatic disease on pelvic computed tomography (ct) or magnetic resonance imaging (mri) within 3 months of study enrollment.
Beschrijving

evidence of metastatic disease on pelvic computed tomography or magnetic resonance imaging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0581420
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0203201
7. zubrod performance status < 2.
Beschrijving

Zubrod performance status

Datatype

boolean

Alias
UMLS CUI [1]
C3714786
8. must be able to understand protocol and adhere to follow-up initially at 3 months post-radiation and then at 6 month intervals for first two years and annually thereafter.
Beschrijving

Compliance behavior

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
9. patient must be able to undergo adequate daily trans-abdominal ultrasound localization (b.a.t.) or other image-guided localization of the prostate during radiation course.
Beschrijving

trans-abdominal ultrasound localization

Datatype

boolean

Alias
UMLS CUI [1,1]
C0855818
UMLS CUI [1,2]
C2348813
10. patients will be allowed to participate in other protocols if they are eligible and the other protocols do not interfere with participation in this protocol.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who do not meet the inclusion criteria. specifically, patients with all the following features: clinical t1c-2a and gleason sum of 6 and psa </= 10 ng/ml. patients with one or more of the following features: clinical t2c, or gleason 8-10, or psa > 20 ng/ml are not eligible.
Beschrijving

AJCC tumor staging; Gleason score; PSA

Datatype

boolean

Alias
UMLS CUI [1]
C0441915
UMLS CUI [2]
C0332326
UMLS CUI [3]
C0201544
2. prior androgen suppression therapy. (prior finasteride and saw palmetto allowed but must be discontinued prior to enrollment. biopsy and psa must be documented prior to finasteride use.)
Beschrijving

androgen suppression therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1515985
3. previous or concurrent malignancies other than basal or squamous cell skin cancers unless disease-free for 5 years or more.
Beschrijving

Malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
4. prior pelvic radiation or chemotherapy. patients who received chemotherapy for non-prostate cancer malignancies over 5 years prior will be eligible.
Beschrijving

pelvic radiation or chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0747411
UMLS CUI [2]
C0392920
5. prior or planned radical prostate surgery.
Beschrijving

radical prostate surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0194810
6. patients with clinical evidence or biopsy-proven extracapsular extension, seminal vesicle involvement, or lymph node involvement will be excluded. patients with radiographic evidence of nodal or bone metastasis will be excluded.
Beschrijving

extracapsular extension, seminal vesicle involvement, lymph node involvement

Datatype

boolean

Alias
UMLS CUI [1]
C1276489
UMLS CUI [2]
C1302434
UMLS CUI [3]
C0806692
7. other histologies such as small cell carcinoma, sarcomatoid or ductal variants are not eligible.
Beschrijving

Small cell carcinoma, sarcomatoid or ductal variants

Datatype

boolean

Alias
UMLS CUI [1]
C1300585
UMLS CUI [2]
C1335519
UMLS CUI [3]
C0349672
8. patients with any gleason grade 5 disease on biopsy will not be eligible.
Beschrijving

Gleason grade

Datatype

boolean

Alias
UMLS CUI [1]
C0332326
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Similar models

Eligibility Prostate Cancer NCT00388804

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
prostate cancer
Item
1. biopsy proven prostate cancer within last 12 months. pathology must be reviewed at m.d. anderson cancer center (mdacc).
boolean
C0600139 (UMLS CUI [1])
AJCC tumor staging; Gleason score; PSA
Item
2. 1992 american joint committee on cancer (ajcc) clinical stage t1c-2b on digital rectal exam with biopsy gleason sum of 7 and prostate-specific antigen (psa) < 20 ng/ml (i.e. psa 19.99 ng/ml or less)
boolean
C0441915 (UMLS CUI [1])
C0332326 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
AJCC tumor staging; Gleason score; PSA
Item
3. 1992 ajcc clinical stage t2b on physical exam with biopsy gleason sum of 7 or less and/or psa < 20 ng/ml
boolean
C0441915 (UMLS CUI [1])
C0332326 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
AJCC tumor staging; Gleason score; PSA
Item
4. 1992 ajcc clinical stage t1c-2b on digital rectal exam with biopsy gleason sum of 7 or less and psa > 10 but less than 20 ng/ml (i.e. 10.01-19.99 ng/ml). psa used for protocol eligibility should be obtained within 30 days of protocol enrollment.
boolean
C0441915 (UMLS CUI [1])
C0332326 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
metastatic disease on bone scan
Item
5. no evidence of metastatic disease on bone scan within 3 months of study enrollment.
boolean
C0027627 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
evidence of metastatic disease on pelvic computed tomography or magnetic resonance imaging
Item
6. no evidence of metastatic disease on pelvic computed tomography (ct) or magnetic resonance imaging (mri) within 3 months of study enrollment.
boolean
C0027627 (UMLS CUI [1,1])
C0581420 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0203201 (UMLS CUI [2,2])
Zubrod performance status
Item
7. zubrod performance status < 2.
boolean
C3714786 (UMLS CUI [1])
Compliance behavior
Item
8. must be able to understand protocol and adhere to follow-up initially at 3 months post-radiation and then at 6 month intervals for first two years and annually thereafter.
boolean
C1321605 (UMLS CUI [1])
trans-abdominal ultrasound localization
Item
9. patient must be able to undergo adequate daily trans-abdominal ultrasound localization (b.a.t.) or other image-guided localization of the prostate during radiation course.
boolean
C0855818 (UMLS CUI [1,1])
C2348813 (UMLS CUI [1,2])
Study Subject Participation Status
Item
10. patients will be allowed to participate in other protocols if they are eligible and the other protocols do not interfere with participation in this protocol.
boolean
C2348568 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
AJCC tumor staging; Gleason score; PSA
Item
1. patients who do not meet the inclusion criteria. specifically, patients with all the following features: clinical t1c-2a and gleason sum of 6 and psa </= 10 ng/ml. patients with one or more of the following features: clinical t2c, or gleason 8-10, or psa > 20 ng/ml are not eligible.
boolean
C0441915 (UMLS CUI [1])
C0332326 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
androgen suppression therapy
Item
2. prior androgen suppression therapy. (prior finasteride and saw palmetto allowed but must be discontinued prior to enrollment. biopsy and psa must be documented prior to finasteride use.)
boolean
C1515985 (UMLS CUI [1])
Malignancy
Item
3. previous or concurrent malignancies other than basal or squamous cell skin cancers unless disease-free for 5 years or more.
boolean
C0006826 (UMLS CUI [1])
pelvic radiation or chemotherapy
Item
4. prior pelvic radiation or chemotherapy. patients who received chemotherapy for non-prostate cancer malignancies over 5 years prior will be eligible.
boolean
C0747411 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
radical prostate surgery
Item
5. prior or planned radical prostate surgery.
boolean
C0194810 (UMLS CUI [1])
extracapsular extension, seminal vesicle involvement, lymph node involvement
Item
6. patients with clinical evidence or biopsy-proven extracapsular extension, seminal vesicle involvement, or lymph node involvement will be excluded. patients with radiographic evidence of nodal or bone metastasis will be excluded.
boolean
C1276489 (UMLS CUI [1])
C1302434 (UMLS CUI [2])
C0806692 (UMLS CUI [3])
Small cell carcinoma, sarcomatoid or ductal variants
Item
7. other histologies such as small cell carcinoma, sarcomatoid or ductal variants are not eligible.
boolean
C1300585 (UMLS CUI [1])
C1335519 (UMLS CUI [2])
C0349672 (UMLS CUI [3])
Gleason grade
Item
8. patients with any gleason grade 5 disease on biopsy will not be eligible.
boolean
C0332326 (UMLS CUI [1])
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