ID

13100

Description

Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00003225

Link

https://clinicaltrials.gov/show/NCT00003225

Keywords

Versions (1)
  1. 1/17/16 1/17/16 -
Uploaded on

January 17, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Colorectal Cancer NCT00003225

English

Eligibility Colorectal Cancer NCT00003225

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog 0-2
Description

Ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 12 weeks
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
pathologically confirmed diagnosis of metastatic colorectal cancer
Description

metastatic colorectal cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0027627
measureable disease
Description

measureable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
have not received therapy for cancer within 4 weeks of enrollment on study
Description

prior therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0011008
prior radiation therapy to the pelvis for treatment of colorectal cancer is allowed. radiation therapy delivered elsewhere is allowed as long as the patient has been off treatment for at least six weeks and measurable lesions are present outside the radiation field
Description

prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1513040
pretreatment granulocyte count of > 1500/mm3, hemoglobin > 9.0 g/dl (without transfusion), and platelet count of > 100,000/um
Description

granulocyte count, hemoglobin, platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0019046
UMLS CUI [3]
C0005821
serum creatinine < 2.0 mg/dl
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
adequate hepatic function as documented by a serum bilirubin < 2.0 mg/dl regardless of whether patients have liver involvement secondary to tumor. ast must be < 3x the upper limit of normal unless the liver is involved with tumor, in which case the ast must be < 5x institutional upper limit of normal
Description

liver function, serum bilirubin, ast

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205411
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior therapy with irinotecan
Description

irinotecan

Data type

boolean

Alias
UMLS CUI [1]
C0123931
patients with any active or uncontrolled infection
Description

active or uncontrolled infection

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with psychiatric disorders that would interfere with consent or follow-up
Description

psychiatric disorders that would interfere with consent or follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0004936
patients with a history of myocardial infarction within the previous six months, congestive heart failure, or cerebrovascular disease
Description

myocardial infarction, congestive heart failure or cerebrovascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0007820
UMLS CUI [3]
C0018802
history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years
Description

malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0553723
UMLS CUI [3]
C0007117
UMLS CUI [4,1]
C0302592
UMLS CUI [4,2]
C0007099
presence of clinically apparent central nervous system metastases or carcinomatous meningitis
Description

cns metastases, carcinomatous meningitis

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220654
patients with uncontrolled diabetes mellitus
Description

uncontrolled diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205318
any other sever concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Description

concurrent disease which would make the patient inappropriate for entry into this study

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients unable to stop taking antihypertensive medication 24 hour prior to administration of ethyol (off x 1 day)
Description

antihypertensive medication,

Data type

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2]
C0015020
Back to the top of the page

Similar models

Eligibility Colorectal Cancer NCT00003225

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Ecog
Item
ecog 0-2
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
metastatic colorectal cancer
Item
pathologically confirmed diagnosis of metastatic colorectal cancer
boolean
C0009402 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
measureable disease
Item
measureable disease
boolean
C1513041 (UMLS CUI [1])
prior therapy
Item
have not received therapy for cancer within 4 weeks of enrollment on study
boolean
C1514463 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
prior radiation therapy
Item
prior radiation therapy to the pelvis for treatment of colorectal cancer is allowed. radiation therapy delivered elsewhere is allowed as long as the patient has been off treatment for at least six weeks and measurable lesions are present outside the radiation field
boolean
C1522449 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
granulocyte count, hemoglobin, platelet count
Item
pretreatment granulocyte count of > 1500/mm3, hemoglobin > 9.0 g/dl (without transfusion), and platelet count of > 100,000/um
boolean
C0857490 (UMLS CUI [1])
C0019046 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
serum creatinine
Item
serum creatinine < 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
liver function, serum bilirubin, ast
Item
adequate hepatic function as documented by a serum bilirubin < 2.0 mg/dl regardless of whether patients have liver involvement secondary to tumor. ast must be < 3x the upper limit of normal unless the liver is involved with tumor, in which case the ast must be < 5x institutional upper limit of normal
boolean
C0232741 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
irinotecan
Item
prior therapy with irinotecan
boolean
C0123931 (UMLS CUI [1])
active or uncontrolled infection
Item
patients with any active or uncontrolled infection
boolean
C0009488 (UMLS CUI [1])
psychiatric disorders that would interfere with consent or follow-up
Item
patients with psychiatric disorders that would interfere with consent or follow-up
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
myocardial infarction, congestive heart failure or cerebrovascular disease
Item
patients with a history of myocardial infarction within the previous six months, congestive heart failure, or cerebrovascular disease
boolean
C0027051 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
malignancies
Item
history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years
boolean
C0006826 (UMLS CUI [1])
C0553723 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0302592 (UMLS CUI [4,1])
C0007099 (UMLS CUI [4,2])
cns metastases, carcinomatous meningitis
Item
presence of clinically apparent central nervous system metastases or carcinomatous meningitis
boolean
C0686377 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
uncontrolled diabetes mellitus
Item
patients with uncontrolled diabetes mellitus
boolean
C0011849 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
concurrent disease which would make the patient inappropriate for entry into this study
Item
any other sever concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
boolean
C0009488 (UMLS CUI [1])
antihypertensive medication,
Item
patients unable to stop taking antihypertensive medication 24 hour prior to administration of ethyol (off x 1 day)
boolean
C0003364 (UMLS CUI [1])
C0015020 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial