ID

36556

Beschrijving

Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02460419

Link

https://clinicaltrials.gov/show/NCT02460419

Trefwoorden

Versies (1)
  1. 21-05-19 21-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

21 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Nasopharyngeal Carcinoma NCT02460419

Engels

Eligibility Nasopharyngeal Carcinoma NCT02460419

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
firstly diagnosed metastatic nasopharyngeal carcinoma patients
Beschrijving

Nasopharyngeal carcinoma metastatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C1522484
disease controlled after 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine
Beschrijving

Disease Controlled | Status post Chemotherapy cycle Palliative Quantity | Taxol | Cisplatin | capecitabine

Datatype

boolean

Alias
UMLS CUI [1]
C2911690
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1302181
UMLS CUI [2,3]
C1285530
UMLS CUI [2,4]
C1265611
UMLS CUI [3]
C0678133
UMLS CUI [4]
C0008838
UMLS CUI [5]
C0671970
eastern cooperative oncology group (ecog) 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectation at least 12 weeks
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
no systemic chemotherapy within 6 months, except for induction chemotherapy or concurrent chemotherapy
Beschrijving

Systemic Chemotherapy Absent | Exception Induction Chemotherapy | Exception Chemotherapy Concurrent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3179010
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C0205420
with at least one measurable lesion
Beschrijving

Measurable lesion Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
enough blood test
Beschrijving

Hematologic Tests Sufficient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0205410
signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
sever heart disease
Beschrijving

Heart Disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
hiv infection
Beschrijving

HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
sever infection
Beschrijving

Communicable Disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
brain metastasis, except received radical therapy 6 months ago and stable in 4 weeks
Beschrijving

Metastatic malignant neoplasm to brain | Exception Treatment Radical | Exception Stable status

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0439807
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0205360
allogeneic organ transplantation
Beschrijving

Organ Transplantation Allogeneic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C1515895
malignancy other than nasopharyngeal carcinoma, except:cervical carcinoma in situ, cured basal cell carcinoma,bladder cancer of ta,tis or t1, or any cured cancer for at least 3 years
Beschrijving

Malignant Neoplasms | Exception Nasopharyngeal carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Cured | Exception Carcinoma of bladder TNM clinical staging | Exception Malignant Neoplasms Cured

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2931822
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1880198
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0699885
UMLS CUI [5,3]
C3258246
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C1880198
pregnancy or breast feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
difficulty in swallowing
Beschrijving

Deglutition Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0011168
received other test drugs
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Nasopharyngeal Carcinoma NCT02460419

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal carcinoma metastatic
Item
firstly diagnosed metastatic nasopharyngeal carcinoma patients
boolean
C2931822 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
Disease Controlled | Status post Chemotherapy cycle Palliative Quantity | Taxol | Cisplatin | capecitabine
Item
disease controlled after 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine
boolean
C2911690 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1302181 (UMLS CUI [2,2])
C1285530 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0678133 (UMLS CUI [3])
C0008838 (UMLS CUI [4])
C0671970 (UMLS CUI [5])
ECOG performance status
Item
eastern cooperative oncology group (ecog) 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectation at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Systemic Chemotherapy Absent | Exception Induction Chemotherapy | Exception Chemotherapy Concurrent
Item
no systemic chemotherapy within 6 months, except for induction chemotherapy or concurrent chemotherapy
boolean
C1883256 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C3179010 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0205420 (UMLS CUI [3,3])
Measurable lesion Quantity
Item
with at least one measurable lesion
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Hematologic Tests Sufficient
Item
enough blood test
boolean
C0018941 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Disease Severe
Item
sever heart disease
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
HIV Infection
Item
hiv infection
boolean
C0019693 (UMLS CUI [1])
Communicable Disease Severe
Item
sever infection
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Exception Treatment Radical | Exception Stable status
Item
brain metastasis, except received radical therapy 6 months ago and stable in 4 weeks
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0439807 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Organ Transplantation Allogeneic
Item
allogeneic organ transplantation
boolean
C0029216 (UMLS CUI [1,1])
C1515895 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Nasopharyngeal carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Cured | Exception Carcinoma of bladder TNM clinical staging | Exception Malignant Neoplasms Cured
Item
malignancy other than nasopharyngeal carcinoma, except:cervical carcinoma in situ, cured basal cell carcinoma,bladder cancer of ta,tis or t1, or any cured cancer for at least 3 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2931822 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1880198 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0699885 (UMLS CUI [5,2])
C3258246 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C1880198 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Deglutition Disorders
Item
difficulty in swallowing
boolean
C0011168 (UMLS CUI [1])
Investigational New Drugs
Item
received other test drugs
boolean
C0013230 (UMLS CUI [1])
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