ID

17231

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00388804

Nyckelord

Versioner (1)
  1. 2016-09-01 2016-09-01 -
Uppladdad den

1 september 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00388804

Engelsk

Eligibility Prostate Cancer NCT00388804

1 Formulär  
Inclusion Criteria
Beskrivning

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).
Beskrivning

prostate cancer

Datatyp

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)
Beskrivning

AJCC tumor staging; Gleason score; PSA

Datatyp

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
Beskrivning

AJCC tumor staging; Gleason score; PSA

Datatyp

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.
Beskrivning

AJCC tumor staging; Gleason score; PSA

Datatyp

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.
Beskrivning

metastatic disease on bone scan

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Zubrod performance status

Datatyp

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.
Beskrivning

Compliance behavior

Datatyp

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.
Beskrivning

trans-abdominal ultrasound localization

Datatyp

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.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria
Beskrivning

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.
Beskrivning

AJCC tumor staging; Gleason score; PSA

Datatyp

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.)
Beskrivning

androgen suppression therapy

Datatyp

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.
Beskrivning

Malignancy

Datatyp

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.
Beskrivning

pelvic radiation or chemotherapy

Datatyp

boolean

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

radical prostate surgery

Datatyp

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.
Beskrivning

extracapsular extension, seminal vesicle involvement, lymph node involvement

Datatyp

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.
Beskrivning

Small cell carcinoma, sarcomatoid or ductal variants

Datatyp

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.
Beskrivning

Gleason grade

Datatyp

boolean

Alias
UMLS CUI [1]
C0332326
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Similar models

Eligibility Prostate Cancer NCT00388804

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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