ID

31612

Beskrivning

Radiotherapy - Adjuvant Versus Early Salvage; ODM derived from: https://clinicaltrials.gov/show/NCT00860652

Länk

https://clinicaltrials.gov/show/NCT00860652

Nyckelord

Versioner (1)
  1. 2018-09-12 2018-09-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00860652

Engelsk

Eligibility Prostate Cancer NCT00860652

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
prior radical prostatectomy (rp) for adenocarcinoma of the prostate.
Beskrivning

Radical prostatectomy Adenocarcinoma of prostate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C0007112
histological confirmation of adenocarcinoma of the prostate with the gleason score reported (radical prostatectomy specimen).
Beskrivning

Adenocarcinoma of prostate Gleason score | Specimen from prostate obtained by radical prostatectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3203027
UMLS CUI [2]
C1292667
patients must have at least one of the following risk factors: 1) positive margins, 2) extraprostatic extension (epe) with or without seminal vesicle involvement (pt3a or pt3b)
Beskrivning

Risk factors Quantity | Positive Surgical Margins | Extraprostatic extension | Seminal Vesicles Involvement TNM clinical staging | Seminal Vesicles Involvement Absent TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1709603
UMLS CUI [3]
C1717821
UMLS CUI [4,1]
C0036628
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C3258246
UMLS CUI [5,1]
C0036628
UMLS CUI [5,2]
C1314939
UMLS CUI [5,3]
C0332197
UMLS CUI [5,4]
C3258246
capable of starting rt within 4 months of rp (a requirement if randomised to adjuvant rt arm)
Beskrivning

Capability Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2698977
UMLS CUI [1,2]
C1522449
most recent psa ≤ 0.10 ng/ml following rp and prior to randomisation
Beskrivning

Prostate specific antigen measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201544
eastern cooperative oncology group (ecog) performance status 0 - 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
patient able to adhere to the specified follow-up schedule and complete the quality of life and anxiety/depression self-assessments
Beskrivning

Follow-up Adherence | Quality of life Self-Assessment Completion | Depressive disorder Self-Assessment Completion | Anxiety Self-Assessment Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1510802
UMLS CUI [2,1]
C0034380
UMLS CUI [2,2]
C0036591
UMLS CUI [2,3]
C0205197
UMLS CUI [3,1]
C0011581
UMLS CUI [3,2]
C0036591
UMLS CUI [3,3]
C0205197
UMLS CUI [4,1]
C0003467
UMLS CUI [4,2]
C0036591
UMLS CUI [4,3]
C0205197
written informed consent obtained prior to randomisation
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
completion of all pre-treatment evaluations
Beskrivning

Evaluation pre treatment Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C2709094
UMLS CUI [1,3]
C0205197
18 years and older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous pelvic rt
Beskrivning

Radiotherapy to pelvis

Datatyp

boolean

Alias
UMLS CUI [1]
C1536155
androgen deprivation (ad) prior to or following rp
Beskrivning

Antiandrogen therapy prior to Radical prostatectomy | Antiandrogen therapy Following Radical prostatectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0194810
UMLS CUI [2,1]
C0279492
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0194810
evidence of nodal or distant metastases
Beskrivning

Secondary malignant neoplasm of lymph node | Distant metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0686619
UMLS CUI [2]
C1269798
co-morbidities that would interfere with the completion of treatment and/or 5 years of follow-up
Beskrivning

Comorbidity Interferes with Treatment completion | Comorbidity Interferes with Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0580352
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3274571
concurrent cytotoxic medication
Beskrivning

Cytotoxic agent

Datatyp

boolean

Alias
UMLS CUI [1]
C0304497
hip prosthesis
Beskrivning

Hip prosthesis

Datatyp

boolean

Alias
UMLS CUI [1]
C0019560
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Similar models

Eligibility Prostate Cancer NCT00860652

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Radical prostatectomy Adenocarcinoma of prostate
Item
prior radical prostatectomy (rp) for adenocarcinoma of the prostate.
boolean
C0194810 (UMLS CUI [1,1])
C0007112 (UMLS CUI [1,2])
Adenocarcinoma of prostate Gleason score | Specimen from prostate obtained by radical prostatectomy
Item
histological confirmation of adenocarcinoma of the prostate with the gleason score reported (radical prostatectomy specimen).
boolean
C0007112 (UMLS CUI [1,1])
C3203027 (UMLS CUI [1,2])
C1292667 (UMLS CUI [2])
Risk factors Quantity | Positive Surgical Margins | Extraprostatic extension | Seminal Vesicles Involvement TNM clinical staging | Seminal Vesicles Involvement Absent TNM clinical staging
Item
patients must have at least one of the following risk factors: 1) positive margins, 2) extraprostatic extension (epe) with or without seminal vesicle involvement (pt3a or pt3b)
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1709603 (UMLS CUI [2])
C1717821 (UMLS CUI [3])
C0036628 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
C0036628 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C3258246 (UMLS CUI [5,4])
Capability Therapeutic radiology procedure
Item
capable of starting rt within 4 months of rp (a requirement if randomised to adjuvant rt arm)
boolean
C2698977 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Prostate specific antigen measurement
Item
most recent psa ≤ 0.10 ng/ml following rp and prior to randomisation
boolean
C0201544 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 - 1
boolean
C1520224 (UMLS CUI [1])
Follow-up Adherence | Quality of life Self-Assessment Completion | Depressive disorder Self-Assessment Completion | Anxiety Self-Assessment Completion
Item
patient able to adhere to the specified follow-up schedule and complete the quality of life and anxiety/depression self-assessments
boolean
C3274571 (UMLS CUI [1,1])
C1510802 (UMLS CUI [1,2])
C0034380 (UMLS CUI [2,1])
C0036591 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0011581 (UMLS CUI [3,1])
C0036591 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C0003467 (UMLS CUI [4,1])
C0036591 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
Informed Consent
Item
written informed consent obtained prior to randomisation
boolean
C0021430 (UMLS CUI [1])
Evaluation pre treatment Completion
Item
completion of all pre-treatment evaluations
boolean
C1261322 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Age
Item
18 years and older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to pelvis
Item
previous pelvic rt
boolean
C1536155 (UMLS CUI [1])
Antiandrogen therapy prior to Radical prostatectomy | Antiandrogen therapy Following Radical prostatectomy
Item
androgen deprivation (ad) prior to or following rp
boolean
C0279492 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0194810 (UMLS CUI [1,3])
C0279492 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0194810 (UMLS CUI [2,3])
Secondary malignant neoplasm of lymph node | Distant metastasis
Item
evidence of nodal or distant metastases
boolean
C0686619 (UMLS CUI [1])
C1269798 (UMLS CUI [2])
Comorbidity Interferes with Treatment completion | Comorbidity Interferes with Follow-up
Item
co-morbidities that would interfere with the completion of treatment and/or 5 years of follow-up
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0580352 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Cytotoxic agent
Item
concurrent cytotoxic medication
boolean
C0304497 (UMLS CUI [1])
Hip prosthesis
Item
hip prosthesis
boolean
C0019560 (UMLS CUI [1])
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