ID

25020

Beschreibung

A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence; ODM derived from: https://clinicaltrials.gov/show/NCT00480623

Link

https://clinicaltrials.gov/show/NCT00480623

Stichworte

Versionen (1)
  1. 24.08.17 24.08.17 -
Hochgeladen am

24. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00480623

Englisch

Eligibility Prostate Cancer NCT00480623

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
over or equal to 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status less than or equal to 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function.
Beschreibung

Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
history of radical prostatectomy with histopathologic documentation of adenocarcinoma of the prostate.
Beschreibung

Radical prostatectomy | Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0194810
UMLS CUI [2]
C0007112
psa over or equal to 0.2 ng/ml or less than or equal to 0.4 ng/ml. this includes patients whose psa never becomes detectable. psa progression must be measured by two consecutive samples, each separated by over or equal to 7 days. the psa values of the two consecutive sample values must be greater than the previous (baseline) value, not greater than each other.
Beschreibung

PSA measurement | PSA Undetectable | PSA Progression Sample Consecutive Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2,1]
C0138741
UMLS CUI [2,2]
C3827727
UMLS CUI [3,1]
C4054264
UMLS CUI [3,2]
C0370003
UMLS CUI [3,3]
C1707491
UMLS CUI [3,4]
C1265611
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known sites of measurable prostate cancer or bone scan positive for metastatic prostate cancer. (patients with a positive prostascint scan will not be excluded)
Beschreibung

Site Known Prostate carcinoma Measurable | Secondary malignant neoplasm of prostate Bone scan Positive | ProstaScint Scan Positive allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0205309
UMLS CUI [1,3]
C0600139
UMLS CUI [1,4]
C1513040
UMLS CUI [2,1]
C0347001
UMLS CUI [2,2]
C0203668
UMLS CUI [2,3]
C1514241
UMLS CUI [3,1]
C2985362
UMLS CUI [3,2]
C1514241
UMLS CUI [3,3]
C0683607
prior therapy for prostate cancer except rp and neoadjuvant hormonal therapy. this includes chemo, hormonal (except neoadjuvant), rt, and biologic therapy.
Beschreibung

Therapeutic procedure Prostate carcinoma | Exception Radical prostatectomy | Exception Hormone Therapy Neoadjuvant | Chemotherapy | Hormone Therapy | Therapeutic radiology procedure | Biological treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0194810
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0279025
UMLS CUI [3,3]
C0600558
UMLS CUI [4]
C0392920
UMLS CUI [5]
C0279025
UMLS CUI [6]
C1522449
UMLS CUI [7]
C1531518
lack of physical integrity of the upper gi tract, malabsorption syndromes, or inability to tolerate or absorb oral medications, including crohn's disease and ulcerative colitis.
Beschreibung

Upper gastrointestinal tract Integrity Lacking | Malabsorption Syndrome | Intolerance to oral medication | Oral medication Intake Unable | Crohn Disease | Ulcerative Colitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1268997
UMLS CUI [1,2]
C1947912
UMLS CUI [1,3]
C0332268
UMLS CUI [2]
C0024523
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0175795
UMLS CUI [4,1]
C0175795
UMLS CUI [4,2]
C1512806
UMLS CUI [4,3]
C1299582
UMLS CUI [5]
C0010346
UMLS CUI [6]
C0009324
other concurrent immunotherapy, rt, chemotherapy,or ancillary therapy considered investigational (utilized for non-fda approved indications and the context of a research investigation)and any chemotherapy not included in the study protocol.
Beschreibung

Immunotherapy Investigational | Therapeutic radiology procedure Investigational | Chemotherapy Investigational | Therapeutic procedure Ancillary Investigational

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C1517586
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1517586
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1517586
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C1549485
UMLS CUI [4,3]
C1517586
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00480623

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
over or equal to 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status less than or equal to 1
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function.
boolean
C0678852 (UMLS CUI [1])
Radical prostatectomy | Adenocarcinoma of prostate
Item
history of radical prostatectomy with histopathologic documentation of adenocarcinoma of the prostate.
boolean
C0194810 (UMLS CUI [1])
C0007112 (UMLS CUI [2])
PSA measurement | PSA Undetectable | PSA Progression Sample Consecutive Quantity
Item
psa over or equal to 0.2 ng/ml or less than or equal to 0.4 ng/ml. this includes patients whose psa never becomes detectable. psa progression must be measured by two consecutive samples, each separated by over or equal to 7 days. the psa values of the two consecutive sample values must be greater than the previous (baseline) value, not greater than each other.
boolean
C0201544 (UMLS CUI [1])
C0138741 (UMLS CUI [2,1])
C3827727 (UMLS CUI [2,2])
C4054264 (UMLS CUI [3,1])
C0370003 (UMLS CUI [3,2])
C1707491 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Site Known Prostate carcinoma Measurable | Secondary malignant neoplasm of prostate Bone scan Positive | ProstaScint Scan Positive allowed
Item
known sites of measurable prostate cancer or bone scan positive for metastatic prostate cancer. (patients with a positive prostascint scan will not be excluded)
boolean
C1515974 (UMLS CUI [1,1])
C0205309 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C1513040 (UMLS CUI [1,4])
C0347001 (UMLS CUI [2,1])
C0203668 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C2985362 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Therapeutic procedure Prostate carcinoma | Exception Radical prostatectomy | Exception Hormone Therapy Neoadjuvant | Chemotherapy | Hormone Therapy | Therapeutic radiology procedure | Biological treatment
Item
prior therapy for prostate cancer except rp and neoadjuvant hormonal therapy. this includes chemo, hormonal (except neoadjuvant), rt, and biologic therapy.
boolean
C0087111 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0194810 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
C0600558 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
C1531518 (UMLS CUI [7])
Upper gastrointestinal tract Integrity Lacking | Malabsorption Syndrome | Intolerance to oral medication | Oral medication Intake Unable | Crohn Disease | Ulcerative Colitis
Item
lack of physical integrity of the upper gi tract, malabsorption syndromes, or inability to tolerate or absorb oral medications, including crohn's disease and ulcerative colitis.
boolean
C1268997 (UMLS CUI [1,1])
C1947912 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0024523 (UMLS CUI [2])
C1744706 (UMLS CUI [3,1])
C0175795 (UMLS CUI [3,2])
C0175795 (UMLS CUI [4,1])
C1512806 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
C0010346 (UMLS CUI [5])
C0009324 (UMLS CUI [6])
Immunotherapy Investigational | Therapeutic radiology procedure Investigational | Chemotherapy Investigational | Therapeutic procedure Ancillary Investigational
Item
other concurrent immunotherapy, rt, chemotherapy,or ancillary therapy considered investigational (utilized for non-fda approved indications and the context of a research investigation)and any chemotherapy not included in the study protocol.
boolean
C0021083 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C1549485 (UMLS CUI [4,2])
C1517586 (UMLS CUI [4,3])
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