0 Ratings
ID

13365

Description

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

Keywords

Versions (1)
  1. 2/9/16 2/9/16 -
Uploaded on

February 9, 2016

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 :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

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

    Eligibility Prostate Cancer NCT00038181

    English

    Eligibility Prostate Cancer NCT00038181

    1 forms  
    Inclusion Criteria
    Description

    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.
    Description

    prostatic adenocarcinoma

    Data type

    boolean

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

    ct, bone scan

    Data type

    boolean

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

    life expectancy

    Data type

    boolean

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

    radical prostatectomy

    Data type

    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).
    Description

    malignancies

    Data type

    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.
    Description

    organ function

    Data type

    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.
    Description

    hypothyroidism

    Data type

    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.
    Description

    informed consent

    Data type

    boolean

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

    compliance

    Data type

    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.
    Description

    thalidomide, contraception

    Data type

    boolean

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

    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.
    Description

    therapy

    Data type

    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.
    Description

    hemorrhage

    Data type

    boolean

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

    comorbidity

    Data type

    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.
    Description

    peripheral neuropathy, anticonvulsants

    Data type

    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.
    Description

    medication

    Data type

    boolean

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

    hiv

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    Back to the top of the page

    Similar models

    Eligibility Prostate Cancer NCT00038181

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

    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