ID

20200

Beskrivning

A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00388700

Länk

https://clinicaltrials.gov/show/NCT00388700

Nyckelord

Versioner (1)
  1. 2017-02-12 2017-02-12 -
Uppladdad den

12 februari 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00388700

Engelsk

Eligibility Colorectal Cancer NCT00388700

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed, unresectable, locally advanced or metastatic colorectal adenocarcinoma (stage iii and iv), not amenable to curative surgery or radiotherapy.
Beskrivning

Adenocarcinoma of large intestine unresectable TNM clinical staging | Adenocarcinoma of large intestine Advanced Local TNM clinical staging | Adenocarcinoma of large intestine metastatic TNM clinical staging | Adenocarcinoma of large intestine Amenable Curative Surgery | Adenocarcinoma of large intestine Amenable Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1319315
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C1319315
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C0205276
UMLS CUI [2,4]
C3258246
UMLS CUI [3,1]
C1319315
UMLS CUI [3,2]
C1522484
UMLS CUI [3,3]
C3258246
UMLS CUI [4,1]
C1319315
UMLS CUI [4,2]
C3900053
UMLS CUI [4,3]
C1511562
UMLS CUI [5,1]
C1319315
UMLS CUI [5,2]
C3900053
UMLS CUI [5,3]
C1522449
intolerant of oxaliplatin and/or irinotecan, as demonstrated by unacceptable toxicity after a trial of these agents as first-line therapy, or in the opinion of the investigator, be judged at high risk for unacceptable toxicity to oxaliplatin and/or irinotecan,
Beskrivning

intolerance to oxaliplatin | intolerance to irinotecan | Toxic effect Post First line treatment | Oxaliplatin Toxic effect High risk of | Irinotecan Toxic effect High risk of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0069717
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0123931
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1708063
UMLS CUI [4,1]
C0069717
UMLS CUI [4,2]
C0600688
UMLS CUI [4,3]
C0332167
UMLS CUI [5,1]
C0123931
UMLS CUI [5,2]
C0600688
UMLS CUI [5,3]
C0332167
presence of at least 1 measurable lesion,
Beskrivning

Measurable Disease Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
have a life expectancy of at least 4 months.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
women of childbearing potential, have a negative serum pregnancy test at screening and day 1 treatment and agree to practice abstinence or use an effective method of contraception.
Beskrivning

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036899
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
central nervous system metastasis.
Beskrivning

CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
bony metastasis as the sole metastasis.
Beskrivning

Secondary malignant neoplasm of bone alone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0205171
received any prior first-line chemotherapy for colorectal cancer.
Beskrivning

First line Chemotherapy Colorectal Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0009402
previously exposed to davanat® or avastin®.
Beskrivning

Exposure to Davanat | Exposure to Avastin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1328211
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C1135130
known or clinically suspected infection with hiv.
Beskrivning

HIV Infection | HIV Infection Suspected clinical

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0019693
UMLS CUI [2,2]
C2732483
participated within 30 days or will participate concurrently in another investigational drug or vaccine study.
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Vaccines

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0042210
history of drug or alcohol dependence in the past 3 years.
Beskrivning

Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that in the judgment of the investigator could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
Beskrivning

Disease Serious Affecting patient safety | Disease Serious Protocol Compliance Limited | Disease Serious Interferes with research results | Mental disorders Serious Affecting patient safety | Mental disorders Serious Protocol Compliance Limited | Mental disorder Serious Interferes with research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0525058
UMLS CUI [2,4]
C0439801
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0392760
UMLS CUI [4,4]
C1113679
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C0525058
UMLS CUI [5,4]
C0439801
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0205404
UMLS CUI [6,3]
C0521102
UMLS CUI [6,4]
C0683954
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Similar models

Eligibility Colorectal Cancer NCT00388700

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years or older.
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of large intestine unresectable TNM clinical staging | Adenocarcinoma of large intestine Advanced Local TNM clinical staging | Adenocarcinoma of large intestine metastatic TNM clinical staging | Adenocarcinoma of large intestine Amenable Curative Surgery | Adenocarcinoma of large intestine Amenable Therapeutic radiology procedure
Item
histologically confirmed, unresectable, locally advanced or metastatic colorectal adenocarcinoma (stage iii and iv), not amenable to curative surgery or radiotherapy.
boolean
C1319315 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1319315 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C1319315 (UMLS CUI [3,1])
C1522484 (UMLS CUI [3,2])
C3258246 (UMLS CUI [3,3])
C1319315 (UMLS CUI [4,1])
C3900053 (UMLS CUI [4,2])
C1511562 (UMLS CUI [4,3])
C1319315 (UMLS CUI [5,1])
C3900053 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
intolerance to oxaliplatin | intolerance to irinotecan | Toxic effect Post First line treatment | Oxaliplatin Toxic effect High risk of | Irinotecan Toxic effect High risk of
Item
intolerant of oxaliplatin and/or irinotecan, as demonstrated by unacceptable toxicity after a trial of these agents as first-line therapy, or in the opinion of the investigator, be judged at high risk for unacceptable toxicity to oxaliplatin and/or irinotecan,
boolean
C1744706 (UMLS CUI [1,1])
C0069717 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0123931 (UMLS CUI [2,2])
C0600688 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1708063 (UMLS CUI [3,3])
C0069717 (UMLS CUI [4,1])
C0600688 (UMLS CUI [4,2])
C0332167 (UMLS CUI [4,3])
C0123931 (UMLS CUI [5,1])
C0600688 (UMLS CUI [5,2])
C0332167 (UMLS CUI [5,3])
Measurable Disease Quantity
Item
presence of at least 1 measurable lesion,
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Life Expectancy
Item
have a life expectancy of at least 4 months.
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods
Item
women of childbearing potential, have a negative serum pregnancy test at screening and day 1 treatment and agree to practice abstinence or use an effective method of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
CNS metastases
Item
central nervous system metastasis.
boolean
C0686377 (UMLS CUI [1])
Secondary malignant neoplasm of bone alone
Item
bony metastasis as the sole metastasis.
boolean
C0153690 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
First line Chemotherapy Colorectal Carcinoma
Item
received any prior first-line chemotherapy for colorectal cancer.
boolean
C1708063 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
Exposure to Davanat | Exposure to Avastin
Item
previously exposed to davanat® or avastin®.
boolean
C0332157 (UMLS CUI [1,1])
C1328211 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C1135130 (UMLS CUI [2,2])
HIV Infection | HIV Infection Suspected clinical
Item
known or clinically suspected infection with hiv.
boolean
C0019693 (UMLS CUI [1])
C0019693 (UMLS CUI [2,1])
C2732483 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs | Vaccines
Item
participated within 30 days or will participate concurrently in another investigational drug or vaccine study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
Substance Dependence
Item
history of drug or alcohol dependence in the past 3 years.
boolean
C0038580 (UMLS CUI [1])
Disease Serious Affecting patient safety | Disease Serious Protocol Compliance Limited | Disease Serious Interferes with research results | Mental disorders Serious Affecting patient safety | Mental disorders Serious Protocol Compliance Limited | Mental disorder Serious Interferes with research results
Item
other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that in the judgment of the investigator could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C1113679 (UMLS CUI [4,4])
C0004936 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0439801 (UMLS CUI [5,4])
C0004936 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
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