ID

31193

Beskrivning

Gefitinib 500mg Versus 250mg in Patients With NSCLC With Stable Disease After a Month Treatment of Gefitinib 250mg; ODM derived from: https://clinicaltrials.gov/show/NCT01017679

Länk

https://clinicaltrials.gov/show/NCT01017679

Nyckelord

Versioner (1)
  1. 2018-07-26 2018-07-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 juli 2018

DOI

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Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT01017679

Engelsk

Eligibility Non-small Cell Lung Cancer NCT01017679

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed stage iiib/iv lung cancer(exclude patients confirmed by sputum cytology)
Beskrivning

Malignant neoplasm of lung TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242379
UMLS CUI [1,2]
C3258246
2. received at least one chemotherapy regimen
Beskrivning

Chemotherapy Regimen Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
3. with stable disease after a month treatment of gefitinib(ct scan)
Beskrivning

Stable Disease CT scan | Gefitinib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677946
UMLS CUI [1,2]
C0040405
UMLS CUI [2]
C1122962
4. the radiotherapy focus is not the measurable disease within 4 weeks.the patients received palliative therapy can be included.
Beskrivning

Therapeutic radiology procedure | Measurable Disease | Palliative therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C1513041
UMLS CUI [3]
C0030231
5. age >18 years, either sex
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
6. with a measurable disease(longest diameters >=10mm with spiral computed tomography (ct)and >=20mm with conventional ct) at least according to recist criteria
Beskrivning

Measurable Disease | Longest Diameter Spiral CT | Longest Diameter CT

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0552406
UMLS CUI [2,2]
C0860888
UMLS CUI [3,1]
C0552406
UMLS CUI [3,2]
C0040405
7. who performance status(ps)<= 2 ( patients whit ps=2 should not get worsen within 2 weeks before included)
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
8. n>=1.5×109/l, plt>=1.5×109/l,hb>=10g/dl
Beskrivning

Neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
9. alp<2.5×uln.if alp>=2.5uln, ast&alt should <1.5uln(without liver metastasis) or <5uln(with liver metastasis).tbil<=1.5uln，ast&alt<2.5uln(without liver metastasis) or <5uln (with liver metastasis).
Beskrivning

Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4,1]
C0494165
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0494165
UMLS CUI [5,2]
C0150312
UMLS CUI [6]
C1278039
10. signed and dated informed consent before the start of specific protocol procedures.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
11. recruiting and receiving treatment in 5 days after last ct scan
Beskrivning

Recruitment | Therapeutic procedure | CT scan

Datatyp

boolean

Alias
UMLS CUI [1]
C0242800
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0040405
12. patients able to taken oral drug
Beskrivning

Able to swallow Oral medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. life expectancy <= 12 weeks.patients with metastatic brain tumors without symptoms or had been treated can be included.
Beskrivning

Life Expectancy | Metastatic malignant neoplasm to brain Asymptomatic allowed | Metastatic malignant neoplasm to brain Treated allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231221
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0683607
2. experience of anti-egfr(the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as erlotinib or cetuximab.
Beskrivning

Anti-egfr monoclonal antibody therapy | Other Coding | erlotinib | cetuximab

Datatyp

boolean

Alias
UMLS CUI [1]
C4316122
UMLS CUI [2]
C3846158
UMLS CUI [3]
C1135135
UMLS CUI [4]
C0995188
3. can not take drug orally, have active peptic ulcer,half upper gastrointestinal or have dyspepsia.
Beskrivning

Lacking Able to swallow Oral medication | Peptic Ulcer Upper gastrointestinal tract Half | Dyspepsia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
UMLS CUI [2,1]
C0030920
UMLS CUI [2,2]
C1268997
UMLS CUI [2,3]
C2825407
UMLS CUI [3]
C0013395
4. allergic to gefitinib
Beskrivning

Hypersensitivity Gefitinib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1122962
5. prior exposure to drugs without approval from this research or other study drugs within 21days before the 1st day taken gefitinib 500mg or 250mg.
Beskrivning

Exposure to Pharmaceutical Preparations Other | Investigational New Drugs Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0205394
6. pregnant or breast-feeding women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Beskrivning

Systemic disease Severe Uncontrolled | Respiration Disorders Unstable | Heart Diseases Unstable | Liver diseases Unstable | Kidney Diseases Unstable | Respiration Disorders Uncompensated | Heart Diseases Uncompensated | Liver diseases Uncompensated | Kidney Diseases Uncompensated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0035204
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0035204
UMLS CUI [6,2]
C0205433
UMLS CUI [7,1]
C0018799
UMLS CUI [7,2]
C0205433
UMLS CUI [8,1]
C0023895
UMLS CUI [8,2]
C0205433
UMLS CUI [9,1]
C0022658
UMLS CUI [9,2]
C0205433
8. previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except of cervical carcinoma in situ,basal cell carcinoma within 5 years prior to study entry.
Beskrivning

Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
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Similar models

Eligibility Non-small Cell Lung Cancer NCT01017679

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Malignant neoplasm of lung TNM clinical staging
Item
1. histologically or cytologically confirmed stage iiib/iv lung cancer(exclude patients confirmed by sputum cytology)
boolean
C0242379 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Chemotherapy Regimen Quantity
Item
2. received at least one chemotherapy regimen
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Stable Disease CT scan | Gefitinib
Item
3. with stable disease after a month treatment of gefitinib(ct scan)
boolean
C0677946 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1122962 (UMLS CUI [2])
Therapeutic radiology procedure | Measurable Disease | Palliative therapy
Item
4. the radiotherapy focus is not the measurable disease within 4 weeks.the patients received palliative therapy can be included.
boolean
C1522449 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C0030231 (UMLS CUI [3])
Age
Item
5. age >18 years, either sex
boolean
C0001779 (UMLS CUI [1])
Measurable Disease | Longest Diameter Spiral CT | Longest Diameter CT
Item
6. with a measurable disease(longest diameters >=10mm with spiral computed tomography (ct)and >=20mm with conventional ct) at least according to recist criteria
boolean
C1513041 (UMLS CUI [1])
C0552406 (UMLS CUI [2,1])
C0860888 (UMLS CUI [2,2])
C0552406 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
WHO performance status scale
Item
7. who performance status(ps)<= 2 ( patients whit ps=2 should not get worsen within 2 weeks before included)
boolean
C1298650 (UMLS CUI [1])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
8. n>=1.5×109/l, plt>=1.5×109/l,hb>=10g/dl
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Serum total bilirubin measurement
Item
9. alp<2.5×uln.if alp>=2.5uln, ast&alt should <1.5uln(without liver metastasis) or <5uln(with liver metastasis).tbil<=1.5uln，ast&alt<2.5uln(without liver metastasis) or <5uln (with liver metastasis).
boolean
C0201850 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0494165 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0494165 (UMLS CUI [5,1])
C0150312 (UMLS CUI [5,2])
C1278039 (UMLS CUI [6])
Informed Consent
Item
10. signed and dated informed consent before the start of specific protocol procedures.
boolean
C0021430 (UMLS CUI [1])
Recruitment | Therapeutic procedure | CT scan
Item
11. recruiting and receiving treatment in 5 days after last ct scan
boolean
C0242800 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
Able to swallow Oral medication
Item
12. patients able to taken oral drug
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Life Expectancy | Metastatic malignant neoplasm to brain Asymptomatic allowed | Metastatic malignant neoplasm to brain Treated allowed
Item
1. life expectancy <= 12 weeks.patients with metastatic brain tumors without symptoms or had been treated can be included.
boolean
C0023671 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0220650 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Anti-egfr monoclonal antibody therapy | Other Coding | erlotinib | cetuximab
Item
2. experience of anti-egfr(the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as erlotinib or cetuximab.
boolean
C4316122 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C1135135 (UMLS CUI [3])
C0995188 (UMLS CUI [4])
Lacking Able to swallow Oral medication | Peptic Ulcer Upper gastrointestinal tract Half | Dyspepsia
Item
3. can not take drug orally, have active peptic ulcer,half upper gastrointestinal or have dyspepsia.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
C0030920 (UMLS CUI [2,1])
C1268997 (UMLS CUI [2,2])
C2825407 (UMLS CUI [2,3])
C0013395 (UMLS CUI [3])
Hypersensitivity Gefitinib
Item
4. allergic to gefitinib
boolean
C0020517 (UMLS CUI [1,1])
C1122962 (UMLS CUI [1,2])
Exposure to Pharmaceutical Preparations Other | Investigational New Drugs Other
Item
5. prior exposure to drugs without approval from this research or other study drugs within 21days before the 1st day taken gefitinib 500mg or 250mg.
boolean
C0332157 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
6. pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic disease Severe Uncontrolled | Respiration Disorders Unstable | Heart Diseases Unstable | Liver diseases Unstable | Kidney Diseases Unstable | Respiration Disorders Uncompensated | Heart Diseases Uncompensated | Liver diseases Uncompensated | Kidney Diseases Uncompensated
Item
7. severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0035204 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0035204 (UMLS CUI [6,1])
C0205433 (UMLS CUI [6,2])
C0018799 (UMLS CUI [7,1])
C0205433 (UMLS CUI [7,2])
C0023895 (UMLS CUI [8,1])
C0205433 (UMLS CUI [8,2])
C0022658 (UMLS CUI [9,1])
C0205433 (UMLS CUI [9,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma
Item
8. previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except of cervical carcinoma in situ,basal cell carcinoma within 5 years prior to study entry.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
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