ID

29427

Descrição

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

Palavras-chave

Versões (1)
  1. 22/03/2018 22/03/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

22 de março de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Gastrointestinal Complications NCT00541047

Inglês

Eligibility Gastrointestinal Complications NCT00541047

1 Formulários  
Criteria
Descrição

Criteria

Inclusion Criteria
Descrição

Inclusion Criteria

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

Adenocarcinoma of prostate

Tipo de dados

boolean

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

Radical prostatectomy

Tipo de dados

boolean

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

Prostate specific antigen measurement Postoperative

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known distant metastases from prostate cancer
Descrição

Prostate carcinoma Distant metastasis

Tipo de dados

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)
Descrição

Prostate specific antigen measurement | Hormone Therapy

Tipo de dados

boolean

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

Client Characteristics

Tipo de dados

boolean

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

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

Tipo de dados

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:
Descrição

Therapeutic procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0087111
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
see disease characteristics
Descrição

ID.10

Tipo de dados

boolean

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

Study Subject Participation Status | Absence Interference Research results

Tipo de dados

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
Descrição

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

Tipo de dados

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior hormone therapy
Descrição

Prior Hormone Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514460
bilateral orchidectomy
Descrição

Bilateral orchidectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007347
prior pelvic radiotherapy
Descrição

Radiotherapy to pelvis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1536155
neoadjuvant treatment
Descrição

Neoadjuvant Therapy

Tipo de dados

boolean

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

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

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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