ID

29427

Description

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

Link

https://clinicaltrials.gov/show/NCT00541047

Keywords

Versions (1)
  1. 3/22/18 3/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 22, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Gastrointestinal Complications NCT00541047

English

Eligibility Gastrointestinal Complications NCT00541047

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

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

Adenocarcinoma of prostate

Data type

boolean

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

Radical prostatectomy

Data type

boolean

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

Prostate specific antigen measurement Postoperative

Data type

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)
Description

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

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known distant metastases from prostate cancer
Description

Prostate carcinoma Distant metastasis

Data type

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)
Description

Prostate specific antigen measurement | Hormone Therapy

Data type

boolean

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

Client Characteristics

Data type

boolean

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

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

Data type

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:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
see disease characteristics
Description

ID.10

Data type

boolean

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

Study Subject Participation Status | Absence Interference Research results

Data type

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
Description

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

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior hormone therapy
Description

Prior Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514460
bilateral orchidectomy
Description

Bilateral orchidectomy

Data type

boolean

Alias
UMLS CUI [1]
C0007347
prior pelvic radiotherapy
Description

Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
neoadjuvant treatment
Description

Neoadjuvant Therapy

Data type

boolean

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

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

Data type

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
Back to the top of the page

Similar models

Eligibility Gastrointestinal Complications NCT00541047

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial