ID

20210

Description

SU011248 in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Stage IV Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00361244

Link

https://clinicaltrials.gov/show/NCT00361244

Keywords

Versions (1)
  1. 2/13/17 2/13/17 -
Uploaded on

February 13, 2017

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 Carcinoma NCT00361244

English

Eligibility Colorectal Carcinoma NCT00361244

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic proof of adenocarcinoma of the colon or rectum with evidence of metastatic disease. the site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel
Description

Adenocarcinoma of colon | Adenocarcinoma of rectum | Neoplasm Metastasis Evidence of | Site of primary lesion Large Intestine Endoscopy | Site of primary lesion Large Intestine Diagnostic radiologic examination | Site of primary lesion Large Intestine Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0338106
UMLS CUI [2]
C0149978
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332120
UMLS CUI [4,1]
C0449695
UMLS CUI [4,2]
C0021851
UMLS CUI [4,3]
C0014245
UMLS CUI [5,1]
C0449695
UMLS CUI [5,2]
C0021851
UMLS CUI [5,3]
C0043299
UMLS CUI [6,1]
C0449695
UMLS CUI [6,2]
C0021851
UMLS CUI [6,3]
C0543467
patients must have received one (and only one) prior chemotherapy regimen for metastatic disease using 5-fu/lv or xeloda in combination with oxaliplatin and avastin.
Description

Chemotherapy Regimen Quantity Neoplasm Metastasis | fluorouracil/L-leucovorin | Xeloda | oxaliplatin | Avastin

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
UMLS CUI [2]
C0280780
UMLS CUI [3]
C0724419
UMLS CUI [4]
C0069717
UMLS CUI [5]
C1135130
> 4 weeks must have elapsed from the time of major surgery
Description

Major surgery Elapsed Time

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C2826303
> 2 weeks must have elapsed from the time of minor surgery
Description

Minor Surgical Procedures Elapsed Time

Data type

boolean

Alias
UMLS CUI [1,1]
C0038904
UMLS CUI [1,2]
C2826303
> 4 weeks must have elapsed from the time of major radiotherapy
Description

Therapeutic radiology procedure Major Elapsed Time

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C2826303
normal organ and marrow function
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
measurable disease be recist criteria
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
older than 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with irinotecan, cetuximab or su011248
Description

irinotecan | cetuximab | SU 11248

Data type

boolean

Alias
UMLS CUI [1]
C0123931
UMLS CUI [2]
C0995188
UMLS CUI [3]
C1176021
any of the following within the 12 months prior to study drug administration: severe/unstable angina; myocardial infarction; symptomatic congestive heart failure; cerebrovascular accident; or transient ischemic attack.
Description

Angina, Unstable | Angina Pectoris Severe | Myocardial Infarction | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0742758
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
known brain metastases or carcinomatous meningitis
Description

Metastatic malignant neoplasm to brain | Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0220654
uncontrolled serious medical or psychiatric illness
Description

Illness Serious Uncontrolled | Mental disorder Serious Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
nci ctcae grade 3 or greater hemorrhage within 4 weeks of starting study treatment
Description

Hemorrhage CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1516728
uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
diagnosis of any secondary malignancies with the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, localized prostate cancer with a normal psa within the past 3 months, in situ bladder cancer, or in situ cervical cancer
Description

Secondary Malignant Neoplasm | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Prostate carcinoma Localized Prostate specific antigen normal | Carcinoma in situ of bladder Treated | Carcinoma in situ of uterine cervix Treated

Data type

boolean

Alias
UMLS CUI [1]
C3266877
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0600139
UMLS CUI [4,2]
C0392752
UMLS CUI [4,3]
C0580554
UMLS CUI [5,1]
C0154091
UMLS CUI [5,2]
C1522326
UMLS CUI [6,1]
C0851140
UMLS CUI [6,2]
C1522326
pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
concurrent treatment on another clinical trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Back to the top of the page

Similar models

Eligibility Colorectal Carcinoma NCT00361244

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon | Adenocarcinoma of rectum | Neoplasm Metastasis Evidence of | Site of primary lesion Large Intestine Endoscopy | Site of primary lesion Large Intestine Diagnostic radiologic examination | Site of primary lesion Large Intestine Operative Surgical Procedures
Item
histologic proof of adenocarcinoma of the colon or rectum with evidence of metastatic disease. the site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
C0027627 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C0449695 (UMLS CUI [4,1])
C0021851 (UMLS CUI [4,2])
C0014245 (UMLS CUI [4,3])
C0449695 (UMLS CUI [5,1])
C0021851 (UMLS CUI [5,2])
C0043299 (UMLS CUI [5,3])
C0449695 (UMLS CUI [6,1])
C0021851 (UMLS CUI [6,2])
C0543467 (UMLS CUI [6,3])
Chemotherapy Regimen Quantity Neoplasm Metastasis | fluorouracil/L-leucovorin | Xeloda | oxaliplatin | Avastin
Item
patients must have received one (and only one) prior chemotherapy regimen for metastatic disease using 5-fu/lv or xeloda in combination with oxaliplatin and avastin.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0280780 (UMLS CUI [2])
C0724419 (UMLS CUI [3])
C0069717 (UMLS CUI [4])
C1135130 (UMLS CUI [5])
Major surgery Elapsed Time
Item
> 4 weeks must have elapsed from the time of major surgery
boolean
C0679637 (UMLS CUI [1,1])
C2826303 (UMLS CUI [1,2])
Minor Surgical Procedures Elapsed Time
Item
> 2 weeks must have elapsed from the time of minor surgery
boolean
C0038904 (UMLS CUI [1,1])
C2826303 (UMLS CUI [1,2])
Therapeutic radiology procedure Major Elapsed Time
Item
> 4 weeks must have elapsed from the time of major radiotherapy
boolean
C1522449 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C2826303 (UMLS CUI [1,3])
Organ function | Bone Marrow function
Item
normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Measurable Disease
Item
measurable disease be recist criteria
boolean
C1513041 (UMLS CUI [1])
Age
Item
older than 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 12 weeks
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
irinotecan | cetuximab | SU 11248
Item
previous treatment with irinotecan, cetuximab or su011248
boolean
C0123931 (UMLS CUI [1])
C0995188 (UMLS CUI [2])
C1176021 (UMLS CUI [3])
Angina, Unstable | Angina Pectoris Severe | Myocardial Infarction | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack
Item
any of the following within the 12 months prior to study drug administration: severe/unstable angina; myocardial infarction; symptomatic congestive heart failure; cerebrovascular accident; or transient ischemic attack.
boolean
C0002965 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
Metastatic malignant neoplasm to brain | Meningeal Carcinomatosis
Item
known brain metastases or carcinomatous meningitis
boolean
C0220650 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Illness Serious Uncontrolled | Mental disorder Serious Uncontrolled
Item
uncontrolled serious medical or psychiatric illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Hemorrhage CTCAE Grades
Item
nci ctcae grade 3 or greater hemorrhage within 4 weeks of starting study treatment
boolean
C0019080 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Secondary Malignant Neoplasm | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Prostate carcinoma Localized Prostate specific antigen normal | Carcinoma in situ of bladder Treated | Carcinoma in situ of uterine cervix Treated
Item
diagnosis of any secondary malignancies with the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, localized prostate cancer with a normal psa within the past 3 months, in situ bladder cancer, or in situ cervical cancer
boolean
C3266877 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0600139 (UMLS CUI [4,1])
C0392752 (UMLS CUI [4,2])
C0580554 (UMLS CUI [4,3])
C0154091 (UMLS CUI [5,1])
C1522326 (UMLS CUI [5,2])
C0851140 (UMLS CUI [6,1])
C1522326 (UMLS CUI [6,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
concurrent treatment on another clinical trial
boolean
C2348568 (UMLS CUI [1])
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