ID

31637

Description

Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy; ODM derived from: https://clinicaltrials.gov/show/NCT00969111

Link

https://clinicaltrials.gov/show/NCT00969111

Keywords

Versions (1)
  1. 9/15/18 9/15/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 15, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00969111

English

Eligibility Prostate Cancer NCT00969111

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
Description

Open prostatectomy Prostate carcinoma | Laparoscopic Prostatectomy Prostate carcinoma | Prostatectomy robotic-assisted Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0341616
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C2986522
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C2922133
UMLS CUI [3,2]
C0600139
maximum psa value of 20 ng/ml.
Description

Prostate-Specific Antigen Value Maximum

Data type

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C1522609
UMLS CUI [1,3]
C0806909
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of distant metastasis (m1).
Description

Distant metastasis TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C3258246
prior systemic chemotherapy for any reason.
Description

Systemic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1883256
previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
Description

Radiotherapy to pelvis compromises Investigational Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1536155
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0949266
active inflammatory bowel disease (crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (non-active diverticulitis and crohn's disease not affecting the rectum are allowed).
Description

Inflammatory Bowel Disease Affecting Rectum | Crohn Disease Affecting Rectum | Diverticulitis Affecting Rectum | Ulcerative Colitis Affecting Rectum

Data type

boolean

Alias
UMLS CUI [1,1]
C0021390
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0034896
UMLS CUI [2,1]
C0010346
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0034896
UMLS CUI [3,1]
C0012813
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0034896
UMLS CUI [4,1]
C0009324
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0034896
history of hip replacement.
Description

Hip Replacement

Data type

boolean

Alias
UMLS CUI [1]
C0392806
prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
Description

Cancer Other | Exception Skin carcinoma | Exception Disease Free of

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
taking saw palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Description

Saw palmetto extract Unable to discontinue | Methotrexate Unable to discontinue | Saw palmetto extract Discontinue Unwilling | Methotrexate Discontinue Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0771607
UMLS CUI [1,2]
C1548265
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C1548265
UMLS CUI [3,1]
C0771607
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C0025677
UMLS CUI [4,2]
C1444662
UMLS CUI [4,3]
C0558080
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Similar models

Eligibility Prostate Cancer NCT00969111

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Open prostatectomy Prostate carcinoma | Laparoscopic Prostatectomy Prostate carcinoma | Prostatectomy robotic-assisted Prostate carcinoma
Item
prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
boolean
C0341616 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C2986522 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C2922133 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
Prostate-Specific Antigen Value Maximum
Item
maximum psa value of 20 ng/ml.
boolean
C0138741 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Distant metastasis TNM clinical staging
Item
evidence of distant metastasis (m1).
boolean
C1269798 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Systemic Chemotherapy
Item
prior systemic chemotherapy for any reason.
boolean
C1883256 (UMLS CUI [1])
Radiotherapy to pelvis compromises Investigational Therapy
Item
previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
boolean
C1536155 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
Inflammatory Bowel Disease Affecting Rectum | Crohn Disease Affecting Rectum | Diverticulitis Affecting Rectum | Ulcerative Colitis Affecting Rectum
Item
active inflammatory bowel disease (crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (non-active diverticulitis and crohn's disease not affecting the rectum are allowed).
boolean
C0021390 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0034896 (UMLS CUI [1,3])
C0010346 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0034896 (UMLS CUI [2,3])
C0012813 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0034896 (UMLS CUI [3,3])
C0009324 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0034896 (UMLS CUI [4,3])
Hip Replacement
Item
history of hip replacement.
boolean
C0392806 (UMLS CUI [1])
Cancer Other | Exception Skin carcinoma | Exception Disease Free of
Item
prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Saw palmetto extract Unable to discontinue | Methotrexate Unable to discontinue | Saw palmetto extract Discontinue Unwilling | Methotrexate Discontinue Unwilling
Item
taking saw palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
boolean
C0771607 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
C0771607 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0025677 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
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