ID

29427

Beskrivning

Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS); ODM derived from: https://clinicaltrials.gov/show/NCT00541047

Länk

https://clinicaltrials.gov/show/NCT00541047

Nyckelord

Versioner (1)
  1. 2018-03-22 2018-03-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Gastrointestinal Complications NCT00541047

Engelsk

Eligibility Gastrointestinal Complications NCT00541047

1 Formulär  
Criteria
Beskrivning

Criteria

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of nonmetastatic adenocarcinoma of the prostate
Beskrivning

Adenocarcinoma of prostate

Datatyp

boolean

Alias
UMLS CUI [1]
C0007112
must have undergone radical prostatectomy
Beskrivning

Radical prostatectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0194810
post-operative serum prostate-specific antigen (psa) < 0.4 ng/ml
Beskrivning

Prostate specific antigen measurement Postoperative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C0032790
no post-operative biochemical failure, defined as either two consecutive rises in psa and final psa > 0.1 ng/ml or three consecutive rises in psa (for patients undergoing hormone therapy duration randomization)
Beskrivning

Absence Failure Biochemical Postoperative | Raised prostate specific antigen Quantity | Prostate specific antigen measurement Final | Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0162643
UMLS CUI [1,3]
C0205474
UMLS CUI [1,4]
C0032790
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0201544
UMLS CUI [3,2]
C3853528
UMLS CUI [4]
C0279025
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known distant metastases from prostate cancer
Beskrivning

Prostate carcinoma Distant metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C1269798
psa > 5 ng/ml at the time of hormone randomization (for patients undergoing hormone therapy duration randomization)
Beskrivning

Prostate specific antigen measurement | Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2]
C0279025
patient characteristics:
Beskrivning

Client Characteristics

Datatyp

boolean

Alias
UMLS CUI [1]
C0815172
no other active malignancy likely to interfere with protocol treatment or follow-up
Beskrivning

Cancer Other Interferes with Therapeutic procedure | Cancer Other Interferes with Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3274571
prior concurrent therapy:
Beskrivning

Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
see disease characteristics
Beskrivning

ID.10

Datatyp

boolean

co-enrollment to other trials is permitted, providing this does not interfere with the outcome measures
Beskrivning

Study Subject Participation Status | Absence Interference Research results

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
5-α reductase inhibitors, soya, selenium, and vitamin e are acceptable non-trial therapies
Beskrivning

5-alpha Reductase Inhibitors | Soybeans | Selenium | Vitamin E

Datatyp

boolean

Alias
UMLS CUI [1]
C2936788
UMLS CUI [2]
C0037733
UMLS CUI [3]
C0036581
UMLS CUI [4]
C0042874
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior hormone therapy
Beskrivning

Prior Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514460
bilateral orchidectomy
Beskrivning

Bilateral orchidectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0007347
prior pelvic radiotherapy
Beskrivning

Radiotherapy to pelvis

Datatyp

boolean

Alias
UMLS CUI [1]
C1536155
neoadjuvant treatment
Beskrivning

Neoadjuvant Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0600558
other concurrent therapies for prostate cancer (e.g., estrogens or cytotoxic chemotherapy) prior to disease progression
Beskrivning

Therapeutic procedure Prostate carcinoma prior to Disease Progression | Estrogens | Cytotoxic Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0242656
UMLS CUI [2]
C0014939
UMLS CUI [3]
C0677881
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Similar models

Eligibility Gastrointestinal Complications NCT00541047

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
diagnosis of nonmetastatic adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Radical prostatectomy
Item
must have undergone radical prostatectomy
boolean
C0194810 (UMLS CUI [1])
Prostate specific antigen measurement Postoperative
Item
post-operative serum prostate-specific antigen (psa) < 0.4 ng/ml
boolean
C0201544 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
Absence Failure Biochemical Postoperative | Raised prostate specific antigen Quantity | Prostate specific antigen measurement Final | Hormone Therapy
Item
no post-operative biochemical failure, defined as either two consecutive rises in psa and final psa > 0.1 ng/ml or three consecutive rises in psa (for patients undergoing hormone therapy duration randomization)
boolean
C0332197 (UMLS CUI [1,1])
C0162643 (UMLS CUI [1,2])
C0205474 (UMLS CUI [1,3])
C0032790 (UMLS CUI [1,4])
C0178415 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3,1])
C3853528 (UMLS CUI [3,2])
C0279025 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Prostate carcinoma Distant metastasis
Item
known distant metastases from prostate cancer
boolean
C0600139 (UMLS CUI [1,1])
C1269798 (UMLS CUI [1,2])
Prostate specific antigen measurement | Hormone Therapy
Item
psa > 5 ng/ml at the time of hormone randomization (for patients undergoing hormone therapy duration randomization)
boolean
C0201544 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Cancer Other Interferes with Therapeutic procedure | Cancer Other Interferes with Follow-up
Item
no other active malignancy likely to interfere with protocol treatment or follow-up
boolean
C1707251 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1707251 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Item Group
C1512693 (UMLS CUI)
ID.10
Item
see disease characteristics
boolean
Study Subject Participation Status | Absence Interference Research results
Item
co-enrollment to other trials is permitted, providing this does not interfere with the outcome measures
boolean
C2348568 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
5-alpha Reductase Inhibitors | Soybeans | Selenium | Vitamin E
Item
5-α reductase inhibitors, soya, selenium, and vitamin e are acceptable non-trial therapies
boolean
C2936788 (UMLS CUI [1])
C0037733 (UMLS CUI [2])
C0036581 (UMLS CUI [3])
C0042874 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Prior Hormone Therapy
Item
prior hormone therapy
boolean
C1514460 (UMLS CUI [1])
Bilateral orchidectomy
Item
bilateral orchidectomy
boolean
C0007347 (UMLS CUI [1])
Radiotherapy to pelvis
Item
prior pelvic radiotherapy
boolean
C1536155 (UMLS CUI [1])
Neoadjuvant Therapy
Item
neoadjuvant treatment
boolean
C0600558 (UMLS CUI [1])
Therapeutic procedure Prostate carcinoma prior to Disease Progression | Estrogens | Cytotoxic Chemotherapy
Item
other concurrent therapies for prostate cancer (e.g., estrogens or cytotoxic chemotherapy) prior to disease progression
boolean
C0087111 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0242656 (UMLS CUI [1,4])
C0014939 (UMLS CUI [2])
C0677881 (UMLS CUI [3])
Tillbaka till toppen 

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