ID

13365

Descrição

Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00038181

Link

https://clinicaltrials.gov/show/NCT00038181

Palavras-chave

Versões (1)
  1. 09.02.16 09.02.16 -
Transferido a

9. Februar 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00038181

Inglês

Eligibility Prostate Cancer NCT00038181

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
prostatic adenocarcinoma without evidence of regional or distant metastases, clinical stage t1c-t2c with gleason score > 7 on initial biopsy and psa > 10 ng/dl or clinical stage t3.
Descrição

prostatic adenocarcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2]
C1300072
negative bone scan and ct abd/pelvis.
Descrição

ct, bone scan

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0040405
UMLS CUI [2]
C0203668
life expectancy of at least 10 years.
Descrição

life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
surgical candidate for radical prostatectomy and ecog performance status of < 2.
Descrição

radical prostatectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0194810
UMLS CUI [2]
C1520224
patients must have no other concurrent malignancies (or within the past 5 years, with the exception of non-melanoma skin cancer or treated superficial transitional cell carcinoma of the bladder).
Descrição

malignancies

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
peripheral granulocyte count > 1,500/mm3, platelet count of > 100,000/mm3 and hb> 10.0 gm/dl, adequate hepatic function with a bilirubin < 1.5 mg % and sgpt < 2.5x the upper limits of normal, and adequate renal function defined as serum creatinine < 1.5 mg% or creatinine clearance > 40 ml/min.
Descrição

organ function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0373595
patients with biochemical hypothyroidism will have their thyroid hormone replaced concurrent with starting the study. patients with clinical hypothyroidism should have their thyroid replaced prior to starting this study.
Descrição

hypothyroidism

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020676
informed consent indicating that patients are aware of the investigational nature of the study, in keeping with the policies of the institution. the only approved consent form is appended to this protocol.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
patients must be willing and able to travel to ut-mdacc for re-evaluation as necessary per protocol.
Descrição

compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
patients should be counseled about the possibility that thalidomide may be present in the semen and must use a latex condom every time they have sexual intercourse with a woman during therapy and for 4 weeks after discontinuing thalidomide, even if they had a successful vasectomy.
Descrição

thalidomide, contraception

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0039736
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0009653
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have received any prior hormonal-, immuno-, radiation or chemo-therapy for prostate carcinoma are excluded from the trial. prior herbal and/or homeopathic medication is allowed if discontinued at least 2 weeks prior to study entry. pc-spes is considered hormonal therapy.
Descrição

therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0087111
patients with history of substantial non-iatrogenic bleeding diathesis and patients with macroscopic hematuria or active gi bleeding are not eligible.
Descrição

hemorrhage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019080
patients with uncontrolled cardiac, respiratory, hepatic, renal, neurologic or psychiatric disorder are excluded from the trial.
Descrição

comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
patients with nci grade 2 or greater peripheral neuropathy of any cause (clinically detectable), or receiving anti-convulsive medications are not eligible for this trial.
Descrição

peripheral neuropathy, anticonvulsants

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C0003286
patients who are receiving sedative/hypnotic agents which cannot be discontinued (if necessary) are not eligible for this study.
Descrição

medication

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013227
patients positive for hiv are excluded from this trial.
Descrição

hiv

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019682
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Similar models

Eligibility Prostate Cancer NCT00038181

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
prostatic adenocarcinoma
Item
prostatic adenocarcinoma without evidence of regional or distant metastases, clinical stage t1c-t2c with gleason score > 7 on initial biopsy and psa > 10 ng/dl or clinical stage t3.
boolean
C0007112 (UMLS CUI [1])
C1300072 (UMLS CUI [2])
ct, bone scan
Item
negative bone scan and ct abd/pelvis.
boolean
C0040405 (UMLS CUI [1])
C0203668 (UMLS CUI [2])
life expectancy
Item
life expectancy of at least 10 years.
boolean
C0023671 (UMLS CUI [1])
radical prostatectomy
Item
surgical candidate for radical prostatectomy and ecog performance status of < 2.
boolean
C0194810 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
malignancies
Item
patients must have no other concurrent malignancies (or within the past 5 years, with the exception of non-melanoma skin cancer or treated superficial transitional cell carcinoma of the bladder).
boolean
C0006826 (UMLS CUI [1])
organ function
Item
peripheral granulocyte count > 1,500/mm3, platelet count of > 100,000/mm3 and hb> 10.0 gm/dl, adequate hepatic function with a bilirubin < 1.5 mg % and sgpt < 2.5x the upper limits of normal, and adequate renal function defined as serum creatinine < 1.5 mg% or creatinine clearance > 40 ml/min.
boolean
C0857490 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0373595 (UMLS CUI [7])
hypothyroidism
Item
patients with biochemical hypothyroidism will have their thyroid hormone replaced concurrent with starting the study. patients with clinical hypothyroidism should have their thyroid replaced prior to starting this study.
boolean
C0020676 (UMLS CUI [1])
informed consent
Item
informed consent indicating that patients are aware of the investigational nature of the study, in keeping with the policies of the institution. the only approved consent form is appended to this protocol.
boolean
C0021430 (UMLS CUI [1])
compliance
Item
patients must be willing and able to travel to ut-mdacc for re-evaluation as necessary per protocol.
boolean
C1321605 (UMLS CUI [1])
thalidomide, contraception
Item
patients should be counseled about the possibility that thalidomide may be present in the semen and must use a latex condom every time they have sexual intercourse with a woman during therapy and for 4 weeks after discontinuing thalidomide, even if they had a successful vasectomy.
boolean
C0039736 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0009653 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
therapy
Item
patients who have received any prior hormonal-, immuno-, radiation or chemo-therapy for prostate carcinoma are excluded from the trial. prior herbal and/or homeopathic medication is allowed if discontinued at least 2 weeks prior to study entry. pc-spes is considered hormonal therapy.
boolean
C0087111 (UMLS CUI [1])
hemorrhage
Item
patients with history of substantial non-iatrogenic bleeding diathesis and patients with macroscopic hematuria or active gi bleeding are not eligible.
boolean
C0019080 (UMLS CUI [1])
comorbidity
Item
patients with uncontrolled cardiac, respiratory, hepatic, renal, neurologic or psychiatric disorder are excluded from the trial.
boolean
C0009488 (UMLS CUI [1])
peripheral neuropathy, anticonvulsants
Item
patients with nci grade 2 or greater peripheral neuropathy of any cause (clinically detectable), or receiving anti-convulsive medications are not eligible for this trial.
boolean
C0031117 (UMLS CUI [1])
C0003286 (UMLS CUI [2])
medication
Item
patients who are receiving sedative/hypnotic agents which cannot be discontinued (if necessary) are not eligible for this study.
boolean
C0013227 (UMLS CUI [1])
hiv
Item
patients positive for hiv are excluded from this trial.
boolean
C0019682 (UMLS CUI [1])
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