ID

31669

Beschreibung

Efficacy and Safety Study of Cetuximab or Cetuximab Plus Docetaxel to Treat Prostate Cancer Before Prostatectomy; ODM derived from: https://clinicaltrials.gov/show/NCT00448097

Link

https://clinicaltrials.gov/show/NCT00448097

Stichworte

Versionen (1)
  1. 19.09.18 19.09.18 -
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See clinicaltrials.gov

Hochgeladen am

19. September 2018

DOI

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Eligibility Prostatic Neoplasms NCT00448097

Englisch

Eligibility Prostatic Neoplasms NCT00448097

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage t1c or t2a with high grade disease (gleason's 8-10) on initial biopsy, or clinical stage t2b-t2c with gleason's grade 7 or above with a psa ≥ 10ng/ml, or clinical stage t3.
Beschreibung

Adenocarcinoma of prostate | Neoplasm Metastasis regional Absent | Distant metastasis Absent | TNM clinical staging | Disease Severe Gleason score Biopsy | Gleason score | Prostate specific antigen measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0205147
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C1269798
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C3258246
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C3203027
UMLS CUI [5,4]
C0005558
UMLS CUI [6]
C3203027
UMLS CUI [7]
C0201544
recent (< 6 weeks prior to study entry) negative bone scan and mri of abdomen and pelvis.
Beschreibung

Abdomen Bone scan Negative | Pelvis Bone scan Negative | MRI of abdomen and pelvis Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C0203668
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C0030797
UMLS CUI [2,2]
C0203668
UMLS CUI [2,3]
C1513916
UMLS CUI [3,1]
C1631605
UMLS CUI [3,2]
C1513916
appropriate surgical candidate for radical prostatectomy and a performance status of < 2 (zubrod scale).
Beschreibung

Patient Appropriate Radical prostatectomy | Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0194810
UMLS CUI [2]
C3714786
patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count > 1,500 and platelet count of > 100,000, adequate hepatic function with a bilirubin < 1.5 mg % and sgpt < 2.5x the upper limits of normal, adequate renal function defined as serum creatinine < 1.5 x uln.
Beschreibung

Bone Marrow function | Absolute neutrophil count Peripheral blood | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2,1]
C0948762
UMLS CUI [2,2]
C0229664
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232741
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0232804
UMLS CUI [8]
C0201976
patients must have normal coagulation profile (pt, ptt) and no history of substantial non-iatrogenic bleeding diatheses. use of anticoagulants is limited to local use only (for control of central line patency).
Beschreibung

Coagulation profile Normal | Prothrombin time assay | Activated Partial Thromboplastin Time measurement | Bleeding tendency Absent | Anticoagulants Local | Control Patency of Central line

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005790
UMLS CUI [1,2]
C0205307
UMLS CUI [2]
C0033707
UMLS CUI [3]
C0030605
UMLS CUI [4,1]
C1458140
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0003280
UMLS CUI [5,2]
C0205276
UMLS CUI [6,1]
C2587213
UMLS CUI [6,2]
C0175566
UMLS CUI [6,3]
C1145640
patients must have no history of congestive heart failure or previous mi within the last 12 months.
Beschreibung

Congestive heart failure Absent | Myocardial Infarction Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0027051
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status drug.
Beschreibung

Hormone Therapy | Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0021083
UMLS CUI [5]
C0013230
unable to tolerate transrectal ultrasound.
Beschreibung

Transrectal ultrasound Receive Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0373345
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death. patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorder are not eligible. patients with uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension are not eligible.
Beschreibung

Patients Inappropriate Radical prostatectomy | Comorbidity Evaluation | Heart Disease Uncontrolled | Liver disease Uncontrolled | Kidney Disease Uncontrolled | Nervous system disorder Uncontrolled | Mental disorders Uncontrolled | Hypotension orthostatic symptomatic Uncontrolled | Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0194810
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1261322
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0027765
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0205318
UMLS CUI [8,1]
C0740482
UMLS CUI [8,2]
C0205318
UMLS CUI [9]
C1868885
patients who are hiv positive or have chronic hepatitis b or c infections are not eligible.
Beschreibung

HIV Seropositivity | Hepatitis B, Chronic | Hepatitis C, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
patients on oral steroid medications are not eligible.
Beschreibung

Steroids Oral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C1527415
patients with significant arteriosclerotic disease, as defined by a previous arterial bypass claudication limiting activity, or a history of cerebrovascular events within the last year (including tia) are not eligible.
Beschreibung

Arteriosclerosis | Artery Bypass | Claudication Limiting Activity | Event Cerebrovascular | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0003850
UMLS CUI [2,1]
C0003842
UMLS CUI [2,2]
C0741847
UMLS CUI [3,1]
C1456822
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0026606
UMLS CUI [4,1]
C0441471
UMLS CUI [4,2]
C1880018
UMLS CUI [5]
C0007787
prior severe infusion reaction to a monoclonal antibody.
Beschreibung

Infusion reaction Severe Monoclonal Antibody

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368034
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0003250
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Ähnliche Modelle

Eligibility Prostatic Neoplasms NCT00448097

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | Neoplasm Metastasis regional Absent | Distant metastasis Absent | TNM clinical staging | Disease Severe Gleason score Biopsy | Gleason score | Prostate specific antigen measurement
Item
histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage t1c or t2a with high grade disease (gleason's 8-10) on initial biopsy, or clinical stage t2b-t2c with gleason's grade 7 or above with a psa ≥ 10ng/ml, or clinical stage t3.
boolean
C0007112 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1269798 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3258246 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C3203027 (UMLS CUI [5,3])
C0005558 (UMLS CUI [5,4])
C3203027 (UMLS CUI [6])
C0201544 (UMLS CUI [7])
Abdomen Bone scan Negative | Pelvis Bone scan Negative | MRI of abdomen and pelvis Negative
Item
recent (< 6 weeks prior to study entry) negative bone scan and mri of abdomen and pelvis.
boolean
C0000726 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0030797 (UMLS CUI [2,1])
C0203668 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C1631605 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
Patient Appropriate Radical prostatectomy | Zubrod Performance Status
Item
appropriate surgical candidate for radical prostatectomy and a performance status of < 2 (zubrod scale).
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0194810 (UMLS CUI [1,3])
C3714786 (UMLS CUI [2])
Bone Marrow function | Absolute neutrophil count Peripheral blood | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count > 1,500 and platelet count of > 100,000, adequate hepatic function with a bilirubin < 1.5 mg % and sgpt < 2.5x the upper limits of normal, adequate renal function defined as serum creatinine < 1.5 x uln.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2,1])
C0229664 (UMLS CUI [2,2])
C0032181 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0232804 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
Coagulation profile Normal | Prothrombin time assay | Activated Partial Thromboplastin Time measurement | Bleeding tendency Absent | Anticoagulants Local | Control Patency of Central line
Item
patients must have normal coagulation profile (pt, ptt) and no history of substantial non-iatrogenic bleeding diatheses. use of anticoagulants is limited to local use only (for control of central line patency).
boolean
C0005790 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0033707 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
C1458140 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0003280 (UMLS CUI [5,1])
C0205276 (UMLS CUI [5,2])
C2587213 (UMLS CUI [6,1])
C0175566 (UMLS CUI [6,2])
C1145640 (UMLS CUI [6,3])
Congestive heart failure Absent | Myocardial Infarction Absent
Item
patients must have no history of congestive heart failure or previous mi within the last 12 months.
boolean
C0018802 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy | Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Investigational New Drugs
Item
previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status drug.
boolean
C0279025 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0013230 (UMLS CUI [5])
Transrectal ultrasound Receive Unable
Item
unable to tolerate transrectal ultrasound.
boolean
C0373345 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Patients Inappropriate Radical prostatectomy | Comorbidity Evaluation | Heart Disease Uncontrolled | Liver disease Uncontrolled | Kidney Disease Uncontrolled | Nervous system disorder Uncontrolled | Mental disorders Uncontrolled | Hypotension orthostatic symptomatic Uncontrolled | Uncontrolled hypertension
Item
patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death. patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorder are not eligible. patients with uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension are not eligible.
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0194810 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0027765 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0740482 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
C1868885 (UMLS CUI [9])
HIV Seropositivity | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
patients who are hiv positive or have chronic hepatitis b or c infections are not eligible.
boolean
C0019699 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
Steroids Oral
Item
patients on oral steroid medications are not eligible.
boolean
C0038317 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Arteriosclerosis | Artery Bypass | Claudication Limiting Activity | Event Cerebrovascular | Transient Ischemic Attack
Item
patients with significant arteriosclerotic disease, as defined by a previous arterial bypass claudication limiting activity, or a history of cerebrovascular events within the last year (including tia) are not eligible.
boolean
C0003850 (UMLS CUI [1])
C0003842 (UMLS CUI [2,1])
C0741847 (UMLS CUI [2,2])
C1456822 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0026606 (UMLS CUI [3,3])
C0441471 (UMLS CUI [4,1])
C1880018 (UMLS CUI [4,2])
C0007787 (UMLS CUI [5])
Infusion reaction Severe Monoclonal Antibody
Item
prior severe infusion reaction to a monoclonal antibody.
boolean
C2368034 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003250 (UMLS CUI [1,3])
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