ID

23715

Descrição

Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00521781

Link

https://clinicaltrials.gov/show/NCT00521781

Palavras-chave

Versões (1)
  1. 11/07/2017 11/07/2017 -
Transferido a

11 de julho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00521781

Inglês

Eligibility Prostatic Neoplasms NCT00521781

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic proof of adenocarcinoma of the prostate.
Descrição

ID.1

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007112
patients must belong to one of four groups: 1) local/regional with prior definitive therapy: patients with local/regional recurrence following prostatectomy or radiation therapy who still have a normal bone scan. 2) local/regional without prior definitive therapy: patients felt to be unresectable, or are felt not to be candidates for, radiation therapy. 3) low volume bone disease: patients with 1 or 2 bone metastases. 4) high volume bone/visceral disease: patients with ≥ 3 metastatic bone sites or visceral metastases.
Descrição

ID.2

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2986592
patients meeting these criteria are eligible even without any radiographically demonstrable abnormality. all patients must have an elevated psa prior to initial hormone exposure defined as: 1) for patients with prior prostatectomy, the psa must be rising with an associated doubling time of ≤ 3 months. 2) for patients with prior radiation therapy, the psa must be ≥ 1.0 ng/ml with an associated doubling time of ≤ 3 months.
Descrição

ID.3

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0178415
3) for patients with the prostate in place, the psa must be elevated with biopsy proven disease and are not candidates for local therapy.
Descrição

ID.4

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0178415
patients may be on an lhrh agonist (with or without an anti-androgen), or already medically castrated, at the time of study entry, provided such therapy was started within 3 months of study entry.
Descrição

ID.5

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1518041
UMLS CUI [1,2]
C1319065
no previous cytotoxic systemic therapy of any kind is allowed, including systemic irradiation with strontium-89 and samarium. previous definitive radiotherapy to one metastatic site is acceptable. at least 8 weeks must have elapsed since radiation therapy to the pelvis. patients having limited irradiation of a single metastatic site are eligible 4 weeks following the completion of radiation.
Descrição

ID.6

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1522449
patients may have had previous exposure to androgen deprivation therapy if it was given for ≤ 6 months to, "downstage" the primary, and provided such therapy completed at least 12 months prior to entry into this study.
Descrição

ID.7

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279492
patients must be free of serious co-morbidity and have a life expectancy of ≥ 3 years.
Descrição

ID.8

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
patients must have adequate physiologic reserves as evidenced by zubrod performance status (zps) of ≤ 2, adequate bone marrow function, renal function and liver function and no evidence of active ischemia on ecg (if clinically indicated, documentation of ef ≥ 40%.)
Descrição

ID.9

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3714786
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have a second malignancy unless there is confidence of previous curative therapy.
Descrição

ID.10

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085183
patients with a recent history of tia (within 6 months), or are requiring regular antianginal therapy or are having claudication sufficient to limit activity are not eligible. patients with a previous history of deep venous thrombosis or pulmonary embolism (within 12 months) are not eligible.
Descrição

ID.11

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007787
UMLS CUI [1,2]
C0585942
UMLS CUI [1,3]
C1456822
UMLS CUI [1,4]
C0042487
UMLS CUI [1,5]
C0034065
patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection.
Descrição

ID.12

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3714514
patients must not have sensory neuropathy of grade 1 or greater.
Descrição

ID.13

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151313
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Similar models

Eligibility Prostatic Neoplasms NCT00521781

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
histologic proof of adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
ID.2
Item
patients must belong to one of four groups: 1) local/regional with prior definitive therapy: patients with local/regional recurrence following prostatectomy or radiation therapy who still have a normal bone scan. 2) local/regional without prior definitive therapy: patients felt to be unresectable, or are felt not to be candidates for, radiation therapy. 3) low volume bone disease: patients with 1 or 2 bone metastases. 4) high volume bone/visceral disease: patients with ≥ 3 metastatic bone sites or visceral metastases.
boolean
C2986592 (UMLS CUI [1])
ID.3
Item
patients meeting these criteria are eligible even without any radiographically demonstrable abnormality. all patients must have an elevated psa prior to initial hormone exposure defined as: 1) for patients with prior prostatectomy, the psa must be rising with an associated doubling time of ≤ 3 months. 2) for patients with prior radiation therapy, the psa must be ≥ 1.0 ng/ml with an associated doubling time of ≤ 3 months.
boolean
C0178415 (UMLS CUI [1])
ID.4
Item
3) for patients with the prostate in place, the psa must be elevated with biopsy proven disease and are not candidates for local therapy.
boolean
C0178415 (UMLS CUI [1])
ID.5
Item
patients may be on an lhrh agonist (with or without an anti-androgen), or already medically castrated, at the time of study entry, provided such therapy was started within 3 months of study entry.
boolean
C1518041 (UMLS CUI [1,1])
C1319065 (UMLS CUI [1,2])
ID.6
Item
no previous cytotoxic systemic therapy of any kind is allowed, including systemic irradiation with strontium-89 and samarium. previous definitive radiotherapy to one metastatic site is acceptable. at least 8 weeks must have elapsed since radiation therapy to the pelvis. patients having limited irradiation of a single metastatic site are eligible 4 weeks following the completion of radiation.
boolean
C0392920 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
ID.7
Item
patients may have had previous exposure to androgen deprivation therapy if it was given for ≤ 6 months to, "downstage" the primary, and provided such therapy completed at least 12 months prior to entry into this study.
boolean
C0279492 (UMLS CUI [1])
ID.8
Item
patients must be free of serious co-morbidity and have a life expectancy of ≥ 3 years.
boolean
C0023671 (UMLS CUI [1])
ID.9
Item
patients must have adequate physiologic reserves as evidenced by zubrod performance status (zps) of ≤ 2, adequate bone marrow function, renal function and liver function and no evidence of active ischemia on ecg (if clinically indicated, documentation of ef ≥ 40%.)
boolean
C3714786 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.10
Item
patients must not have a second malignancy unless there is confidence of previous curative therapy.
boolean
C0085183 (UMLS CUI [1])
ID.11
Item
patients with a recent history of tia (within 6 months), or are requiring regular antianginal therapy or are having claudication sufficient to limit activity are not eligible. patients with a previous history of deep venous thrombosis or pulmonary embolism (within 12 months) are not eligible.
boolean
C0007787 (UMLS CUI [1,1])
C0585942 (UMLS CUI [1,2])
C1456822 (UMLS CUI [1,3])
C0042487 (UMLS CUI [1,4])
C0034065 (UMLS CUI [1,5])
ID.12
Item
patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection.
boolean
C0012634 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
ID.13
Item
patients must not have sensory neuropathy of grade 1 or greater.
boolean
C0151313 (UMLS CUI [1])
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