ID

29426

Beschreibung

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

Stichworte

Versionen (1)
  1. 22.03.18 22.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

22. März 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Gastric Carcinoma NCT00639522

Englisch

Eligibility Gastric Carcinoma NCT00639522

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Stomach Carcinoma Stage Advanced | Stomach Carcinoma Inappropriate Operative Surgical Procedures

Datentyp

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;
Beschreibung

Systemic Chemotherapy Taxane Absent

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

Life Expectancy

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Chemotherapy | Therapeutic radiology procedure

Datentyp

boolean

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

Metastatic malignant neoplasm to brain Symptomatic

Datentyp

boolean

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

Hypersensitivity Investigational New Drugs

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

boolean

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

Heart Diseases Severe

Datentyp

boolean

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

Mental disorders Uncontrolled

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Gastric Carcinoma NCT00639522

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video