Information:
Fel:
ID
23715
Beskrivning
Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00521781
Länk
https://clinicaltrials.gov/show/NCT00521781
Nyckelord
Versioner (1)
- 2017-07-11 2017-07-11 -
Uppladdad den
11 juli 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00521781
Eligibility Prostatic Neoplasms NCT00521781
- StudyEvent: Eligibility
Similar models
Eligibility Prostatic Neoplasms NCT00521781
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
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])
C3714514 (UMLS CUI [1,2])
ID.13
Item
patients must not have sensory neuropathy of grade 1 or greater.
boolean
C0151313 (UMLS CUI [1])