ID

36556

Description

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

Keywords

  1. 5/21/19 5/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 21, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Nasopharyngeal Carcinoma NCT02460419

Eligibility Nasopharyngeal Carcinoma NCT02460419

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
firstly diagnosed metastatic nasopharyngeal carcinoma patients
Description

Nasopharyngeal carcinoma metastatic

Data type

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
Description

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

Data type

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
Description

ECOG performance status

Data type

boolean

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

Life Expectancy

Data type

boolean

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

Systemic Chemotherapy Absent | Exception Induction Chemotherapy | Exception Chemotherapy Concurrent

Data type

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
Description

Measurable lesion Quantity

Data type

boolean

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

Hematologic Tests Sufficient

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
sever heart disease
Description

Heart Disease Severe

Data type

boolean

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

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
sever infection
Description

Communicable Disease Severe

Data type

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
Description

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

Data type

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
Description

Organ Transplantation Allogeneic

Data type

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
Description

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

Data type

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
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Deglutition Disorders

Data type

boolean

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

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230

Similar models

Eligibility Nasopharyngeal Carcinoma NCT02460419

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