ID

29426

Beschrijving

Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00639522

Link

https://clinicaltrials.gov/show/NCT00639522

Trefwoorden

Versies (1)
  1. 22-03-18 22-03-18 -
Houder van rechten

See clinicaltrials.gov

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22 maart 2018

DOI

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Creative Commons BY 4.0
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Eligibility Gastric Carcinoma NCT00639522

Engels

Eligibility Gastric Carcinoma NCT00639522

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically verified gastric carcinoma of advanced stages which is unsuitable for surgery;
Beschrijving

Stomach Carcinoma Stage Advanced | Stomach Carcinoma Inappropriate Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0699791
UMLS CUI [1,2]
C1306673
UMLS CUI [1,3]
C0205179
UMLS CUI [2,1]
C0699791
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0543467
no prior systemic chemotherapy with taxane at least 6 months before the recruitment;
Beschrijving

Systemic Chemotherapy Taxane Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0215136
UMLS CUI [1,3]
C0332197
at least one measurable tumor according to recist standard, with at least one diameter ≥20mm assessed by traditional imaging technique or mri, or with a diameter twice of the thickness of scan layer (or ≥10-16mm) under spiral ct; eastern cooperative oncology group (ecog) performance status (ps) 0-1;
Beschrijving

Measurable Disease Quantity | Diameter Size Quantity Imaging Techniques | Diameter Size MRI | Diameter Size Spiral CT | ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1301886
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0079595
UMLS CUI [3,1]
C1301886
UMLS CUI [3,2]
C0456389
UMLS CUI [3,3]
C0024485
UMLS CUI [4,1]
C1301886
UMLS CUI [4,2]
C0456389
UMLS CUI [4,3]
C0860888
UMLS CUI [5]
C1520224
patients who are expected to live at least 3 months;
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
obtaining informed consent;
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
receiving other chemotherapy or radiotherapy during the administration;
Beschrijving

Chemotherapy | Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
symptomatic metastatic brain tumor;
Beschrijving

Metastatic malignant neoplasm to brain Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
allergy to any study medication;
Beschrijving

Hypersensitivity Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
pregnancy or breast feeding;
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe heart diseases;
Beschrijving

Heart Diseases Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
uncontrolled mental diseases;
Beschrijving

Mental disorders Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
abnormal liver and renal functions, which are measured by ast/alt and bun/cr;
Beschrijving

Liver Dysfunction | Abnormal renal function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Blood urea nitrogen measurement | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151746
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0005845
UMLS CUI [6]
C0201976
neutrophils（anc）<2000/μl;platelets<100，000/μl;hemoglobin（hb）<9.0 g/dl;
Beschrijving

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
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Similar models

Eligibility Gastric Carcinoma NCT00639522

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Stomach Carcinoma Stage Advanced | Stomach Carcinoma Inappropriate Operative Surgical Procedures
Item
histologically verified gastric carcinoma of advanced stages which is unsuitable for surgery;
boolean
C0699791 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C0699791 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Systemic Chemotherapy Taxane Absent
Item
no prior systemic chemotherapy with taxane at least 6 months before the recruitment;
boolean
C1883256 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Measurable Disease Quantity | Diameter Size Quantity Imaging Techniques | Diameter Size MRI | Diameter Size Spiral CT | ECOG performance status
Item
at least one measurable tumor according to recist standard, with at least one diameter ≥20mm assessed by traditional imaging technique or mri, or with a diameter twice of the thickness of scan layer (or ≥10-16mm) under spiral ct; eastern cooperative oncology group (ecog) performance status (ps) 0-1;
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0079595 (UMLS CUI [2,4])
C1301886 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
C1301886 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C0860888 (UMLS CUI [4,3])
C1520224 (UMLS CUI [5])
Life Expectancy
Item
patients who are expected to live at least 3 months;
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
obtaining informed consent;
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure
Item
receiving other chemotherapy or radiotherapy during the administration;
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Metastatic malignant neoplasm to brain Symptomatic
Item
symptomatic metastatic brain tumor;
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs
Item
allergy to any study medication;
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Diseases Severe
Item
severe heart diseases;
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Mental disorders Uncontrolled
Item
uncontrolled mental diseases;
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Liver Dysfunction | Abnormal renal function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Blood urea nitrogen measurement | Creatinine measurement, serum
Item
abnormal liver and renal functions, which are measured by ast/alt and bun/cr;
boolean
C0086565 (UMLS CUI [1])
C0151746 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0005845 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
neutrophils（anc）<2000/μl;platelets<100，000/μl;hemoglobin（hb）<9.0 g/dl;
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
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