ID

18379

Beschrijving

Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site; ODM derived from: https://clinicaltrials.gov/show/NCT00193609

Link

https://clinicaltrials.gov/show/NCT00193609

Trefwoorden

Versies (1)
  1. 02-11-16 02-11-16 -
Geüploaded op

2 november 2016

DOI

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Creative Commons BY 4.0
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Eligibility Neoplasms, Unknown Primary NCT00193609

Engels

Eligibility Neoplasms, Unknown Primary NCT00193609

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
to be included in this study, you must meet the following criteria:
Beschrijving

Clinical Trial Eligibility Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
histologically confirmed carcinoma of unknown primary site
Beschrijving

Carcinoma of unknown primary origin

Datatype

boolean

Alias
UMLS CUI [1]
C0220647
progressive disease after treatment with one previous chemotherapy regimen.
Beschrijving

Chemotherapy Regimen | Progressive Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1335499
treatment with one previous immunotherapy or biotherapy regimen.
Beschrijving

Immunotherapy | Biological Response Modifier Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C0005527
no previous treatment with oxaliplatin, capecitabine, or 5-fu.
Beschrijving

oxaliplatin | capecitabine | Fluorouracil

Datatype

boolean

Alias
UMLS CUI [1]
C0069717
UMLS CUI [2]
C0671970
UMLS CUI [3]
C0016360
previous treatment with other platinum agents
Beschrijving

Platinum-based Drug

Datatype

boolean

Alias
UMLS CUI [1]
C2266918
patients must have measurable or evaluable disease
Beschrijving

Measurable Disease | Evaluable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
ecog performance status more than 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, liver and kidney function
Beschrijving

Bone Marrow function | Liver function | Renal function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
understand the nature of this study and give written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
you cannot participate in this study if any of the following apply to you:
Beschrijving

Clinical Trial Eligibility Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
age < 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
history of treatment of any invasive malignancy within the last 5 years
Beschrijving

Therapeutic procedure Invasive cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0677898
coexistent medical illnesses
Beschrijving

Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
clinically significant cardiac disease
Beschrijving

Heart Disease Clinical Significance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2826293
preexisting peripheral neuropathy > grade 1
Beschrijving

Peripheral Neuropathy | CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
lack of physical integrity of the upper gastrointestinal tract
Beschrijving

Upper Gastrointestinal Tract Integrity Physical Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C3203348
UMLS CUI [1,2]
C0205266
UMLS CUI [1,3]
C0205485
UMLS CUI [1,4]
C0332268
pre-existing uncontrolled coagulopathy
Beschrijving

Blood Coagulation Disorder Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0205318
women who are pregnant or lactating
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Beschrijving

Clinical Trial Eligibility Criteria Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Neoplasms, Unknown Primary NCT00193609

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Eligibility Criteria Fulfill
Item
to be included in this study, you must meet the following criteria:
boolean
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Carcinoma of unknown primary origin
Item
histologically confirmed carcinoma of unknown primary site
boolean
C0220647 (UMLS CUI [1])
Chemotherapy Regimen | Progressive Disease
Item
progressive disease after treatment with one previous chemotherapy regimen.
boolean
C0392920 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
Immunotherapy | Biological Response Modifier Therapy
Item
treatment with one previous immunotherapy or biotherapy regimen.
boolean
C0021083 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
oxaliplatin | capecitabine | Fluorouracil
Item
no previous treatment with oxaliplatin, capecitabine, or 5-fu.
boolean
C0069717 (UMLS CUI [1])
C0671970 (UMLS CUI [2])
C0016360 (UMLS CUI [3])
Platinum-based Drug
Item
previous treatment with other platinum agents
boolean
C2266918 (UMLS CUI [1])
Measurable Disease | Evaluable Disease
Item
patients must have measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status more than 2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and kidney function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Informed Consent
Item
understand the nature of this study and give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Clinical Trial Eligibility Criteria Fulfill
Item
you cannot participate in this study if any of the following apply to you:
boolean
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
age < 18 years
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Invasive cancer
Item
history of treatment of any invasive malignancy within the last 5 years
boolean
C0087111 (UMLS CUI [1,1])
C0677898 (UMLS CUI [1,2])
Comorbidity
Item
coexistent medical illnesses
boolean
C0009488 (UMLS CUI [1])
Heart Disease Clinical Significance
Item
clinically significant cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Peripheral Neuropathy | CTCAE Grades
Item
preexisting peripheral neuropathy > grade 1
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Upper Gastrointestinal Tract Integrity Physical Lacking
Item
lack of physical integrity of the upper gastrointestinal tract
boolean
C3203348 (UMLS CUI [1,1])
C0205266 (UMLS CUI [1,2])
C0205485 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
Blood Coagulation Disorder Uncontrolled
Item
pre-existing uncontrolled coagulopathy
boolean
C0005779 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
women who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Clinical Trial Eligibility Criteria Additional
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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