ID

16186

Description

Trial of Gemcitabine and Cisplatin in Patients With Inoperable Biliary Tract Carcinomas; ODM derived from: https://clinicaltrials.gov/show/NCT00490399

Link

https://clinicaltrials.gov/show/NCT00490399

Keywords

Versions (1)
  1. 7/4/16 7/4/16 -
Uploaded on

July 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Biliary Tract Carcinoma NCT00490399

English

Eligibility Biliary Tract Carcinoma NCT00490399

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic diagnosis of adenocarcinoma of the gallbladder, intra/extrahepatic bile ducts or papilla of vater with locally advanced or metastatic disease (at study entry) that is not amenable to curative surgical resection or with recurrent disease after prior surgical resection or radiotherapy.
Description

Gallbladder adenocarcinoma | Intrahepatic bile duct advanced disease Locally | Extrahepatic Bile Ducts advanced disease Locally | Intrahepatic bile duct Metastatic Neoplasm | Extrahepatic Bile Ducts Metastatic Neoplasm | greater duodenal papilla advanced disease Locally | greater duodenal papilla Metastatic Neoplasm | Amenable Excision Curative | Recurrent disease Post Excision | Recurrent disease Post Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0279651
UMLS CUI [2,1]
C0005401
UMLS CUI [2,2]
C0679246
UMLS CUI [2,3]
C1517927
UMLS CUI [3,1]
C0206187
UMLS CUI [3,2]
C0679246
UMLS CUI [3,3]
C1517927
UMLS CUI [4,1]
C0005401
UMLS CUI [4,2]
C2939420
UMLS CUI [5,1]
C0206187
UMLS CUI [5,2]
C2939420
UMLS CUI [6,1]
C1269002
UMLS CUI [6,2]
C0679246
UMLS CUI [6,3]
C1517927
UMLS CUI [7,1]
C1269002
UMLS CUI [7,2]
C2939420
UMLS CUI [8,1]
C3900053
UMLS CUI [8,2]
C0728940
UMLS CUI [8,3]
C1276305
UMLS CUI [9,1]
C0277556
UMLS CUI [9,2]
C0687676
UMLS CUI [9,3]
C0728940
UMLS CUI [10,1]
C0277556
UMLS CUI [10,2]
C0687676
UMLS CUI [10,3]
C1522449
disease status must be measurable disease defined as: bi-dimensionally measurable lesions with clearly defined margins and two perpendicular diameters that are clearly measurable by following:
Description

Measurable lesion 2-Dimensional | Margin Well defined | Diameter Perpendicular

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [2,1]
C0205284
UMLS CUI [2,2]
C0442825
UMLS CUI [3,1]
C1301886
UMLS CUI [3,2]
C3272860
computerized tomography (ct) or magnetic resonance imaging (mri), with one diameter 2.0 cm or greater and the other diameter 1.0 cm or greater.
Description

X-Ray Computed Tomography | Magnetic Resonance Imaging | Diameter

Data type

boolean

Alias
UMLS CUI [1]
C0040405
UMLS CUI [2]
C0024485
UMLS CUI [3]
C1301886
palpable lesion, with both diameters 2 cm or greater. disease progressing in areas of prior radiation therapy may be included.
Description

Lesion Palpable | Diameter | Disease Progression Area Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0522499
UMLS CUI [2]
C1301886
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0205146
UMLS CUI [3,3]
C1522449
patients must have received no prior chemotherapy for advanced disease.
Description

Prior Chemotherapy advanced disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0679246
prior radiotherapy must be completed at least 4 weeks before study enrollment. patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
Description

prior radiation therapy | Toxic effect acute Recovered

Data type

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0205178
UMLS CUI [2,3]
C0521108
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Description

Drugs, Non-Prescription | Drug Approval regulatory | Indication

Data type

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2,1]
C0162696
UMLS CUI [2,2]
C0220905
UMLS CUI [3]
C3146298
heart failure, angina pectoris or arrhythmia that are poorly controlled in spite of medication or acute myocardial infarction within 6 months preceding study enrollment
Description

Heart failure Poorly controlled | Angina Pectoris Poorly controlled | Cardiac Arrhythmia Poorly controlled | Pharmaceutical Preparations | Acute myocardial infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C3853134
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C3853134
UMLS CUI [4]
C0013227
UMLS CUI [5]
C0155626
severe neurological or mental disorder.
Description

nervous system disorder Severe | Mental disorders Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205082
active infection that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy.
Description

Communicable Disease Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
poorly controlled diabetes mellitus.
Description

poorly controlled diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0554876
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Similar models

Eligibility Biliary Tract Carcinoma NCT00490399

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gallbladder adenocarcinoma | Intrahepatic bile duct advanced disease Locally | Extrahepatic Bile Ducts advanced disease Locally | Intrahepatic bile duct Metastatic Neoplasm | Extrahepatic Bile Ducts Metastatic Neoplasm | greater duodenal papilla advanced disease Locally | greater duodenal papilla Metastatic Neoplasm | Amenable Excision Curative | Recurrent disease Post Excision | Recurrent disease Post Therapeutic radiology procedure
Item
histologic or cytologic diagnosis of adenocarcinoma of the gallbladder, intra/extrahepatic bile ducts or papilla of vater with locally advanced or metastatic disease (at study entry) that is not amenable to curative surgical resection or with recurrent disease after prior surgical resection or radiotherapy.
boolean
C0279651 (UMLS CUI [1])
C0005401 (UMLS CUI [2,1])
C0679246 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C0206187 (UMLS CUI [3,1])
C0679246 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C0005401 (UMLS CUI [4,1])
C2939420 (UMLS CUI [4,2])
C0206187 (UMLS CUI [5,1])
C2939420 (UMLS CUI [5,2])
C1269002 (UMLS CUI [6,1])
C0679246 (UMLS CUI [6,2])
C1517927 (UMLS CUI [6,3])
C1269002 (UMLS CUI [7,1])
C2939420 (UMLS CUI [7,2])
C3900053 (UMLS CUI [8,1])
C0728940 (UMLS CUI [8,2])
C1276305 (UMLS CUI [8,3])
C0277556 (UMLS CUI [9,1])
C0687676 (UMLS CUI [9,2])
C0728940 (UMLS CUI [9,3])
C0277556 (UMLS CUI [10,1])
C0687676 (UMLS CUI [10,2])
C1522449 (UMLS CUI [10,3])
Measurable lesion 2-Dimensional | Margin Well defined | Diameter Perpendicular
Item
disease status must be measurable disease defined as: bi-dimensionally measurable lesions with clearly defined margins and two perpendicular diameters that are clearly measurable by following:
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0205284 (UMLS CUI [2,1])
C0442825 (UMLS CUI [2,2])
C1301886 (UMLS CUI [3,1])
C3272860 (UMLS CUI [3,2])
X-Ray Computed Tomography | Magnetic Resonance Imaging | Diameter
Item
computerized tomography (ct) or magnetic resonance imaging (mri), with one diameter 2.0 cm or greater and the other diameter 1.0 cm or greater.
boolean
C0040405 (UMLS CUI [1])
C0024485 (UMLS CUI [2])
C1301886 (UMLS CUI [3])
Lesion Palpable | Diameter | Disease Progression Area Therapeutic radiology procedure
Item
palpable lesion, with both diameters 2 cm or greater. disease progressing in areas of prior radiation therapy may be included.
boolean
C0221198 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2])
C0242656 (UMLS CUI [3,1])
C0205146 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
Prior Chemotherapy advanced disease
Item
patients must have received no prior chemotherapy for advanced disease.
boolean
C1514457 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
prior radiation therapy | Toxic effect acute Recovered
Item
prior radiotherapy must be completed at least 4 weeks before study enrollment. patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
boolean
C0279134 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0205178 (UMLS CUI [2,2])
C0521108 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Drugs, Non-Prescription | Drug Approval regulatory | Indication
Item
treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
boolean
C0013231 (UMLS CUI [1])
C0162696 (UMLS CUI [2,1])
C0220905 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3])
Heart failure Poorly controlled | Angina Pectoris Poorly controlled | Cardiac Arrhythmia Poorly controlled | Pharmaceutical Preparations | Acute myocardial infarction
Item
heart failure, angina pectoris or arrhythmia that are poorly controlled in spite of medication or acute myocardial infarction within 6 months preceding study enrollment
boolean
C0018801 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4])
C0155626 (UMLS CUI [5])
nervous system disorder Severe | Mental disorders Severe
Item
severe neurological or mental disorder.
boolean
C0027765 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Communicable Disease Compliance behavior Limited
Item
active infection that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy.
boolean
C0009450 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
poorly controlled diabetes mellitus
Item
poorly controlled diabetes mellitus.
boolean
C0554876 (UMLS CUI [1])
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