ID

18379

Description

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

Keywords

Versions (1)
  1. 11/2/16 11/2/16 -
Uploaded on

November 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Neoplasms, Unknown Primary NCT00193609

English

Eligibility Neoplasms, Unknown Primary NCT00193609

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Clinical Trial Eligibility Criteria Fulfill

Data type

boolean

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

Carcinoma of unknown primary origin

Data type

boolean

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

Chemotherapy Regimen | Progressive Disease

Data type

boolean

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

Immunotherapy | Biological Response Modifier Therapy

Data type

boolean

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

oxaliplatin | capecitabine | Fluorouracil

Data type

boolean

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

Platinum-based Drug

Data type

boolean

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

Measurable Disease | Evaluable Disease

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Bone Marrow function | Liver function | Renal function

Data type

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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Clinical Trial Eligibility Criteria Fulfill

Data type

boolean

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

Age

Data type

boolean

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

Therapeutic procedure Invasive cancer

Data type

boolean

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

Comorbidity

Data type

boolean

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

Heart Disease Clinical Significance

Data type

boolean

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

Peripheral Neuropathy | CTCAE Grades

Data type

boolean

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

Upper Gastrointestinal Tract Integrity Physical Lacking

Data type

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
Description

Blood Coagulation Disorder Uncontrolled

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

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.
Description

Clinical Trial Eligibility Criteria Additional

Data type

boolean

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

Eligibility Neoplasms, Unknown Primary NCT00193609

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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