ID

14838

Description

Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00176774

Link

https://clinicaltrials.gov/show/NCT00176774

Keywords

Versions (1)
  1. 5/1/16 5/1/16 -
Uploaded on

May 1, 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 Carcinoma NCT00176774

English

Eligibility Colorectal Carcinoma NCT00176774

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically proven adenocarcinoma primary to the colon or rectum and clinical or pathologic evidence of distant metastasis.
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1,1]
C0001418
UMLS CUI [1,2]
C0034896
UMLS CUI [1,3]
C0001418
UMLS CUI [1,4]
C0009368
UMLS CUI [1,5]
C0019638
UMLS CUI [2]
C0027627
patients may have received adjuvant chemotherapy and/or one regimen of chemotherapy for metastatic disease. patients must not have been previously treated with the combination of irinotecan/5-fu/lv.
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C0123931
UMLS CUI [2,2]
C0016360
UMLS CUI [2,3]
C0023413
patients must be past their 18th birthday at the time of enrollment.
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must have a performance status of 0-2 at the time of registration.
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must have a life expectancy of > 3 months.
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0023671
if patients have undergone recent surgery, they must have fully recovered from the effects of that surgery prior to enrollment.
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C2004454
patients must have a pretreatment leukocyte count > 3,000/l, absolute neutrophil count >1500/l, hemoglobin >8 mg/dl, and platelet count of > 150,000/l within 2 weeks of enrollment.
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
patients must have adequate renal function, as documented by a serum creatinine < 2.0 mg/dl, and have adequate hepatic function, as documented by a serum bilirubin < 1.1 mg/dl within 2 weeks of enrollment.
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have active infection.
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1]
C0009450
patients must have no serious medical or psychiatric illness, other than that treated by this study, which would limit the ability of the patient to receive protocol therapy or give informed consent.
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients must not have a history of active malignancy, other than that treated by this study, within the 12 months preceding enrollment.
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
pregnant or lactating women may not participate. women of reproductive age must undergo a serum pregnancy test within 14 days of enrollment. men and women of reproductive potential must use an effective contraceptive method during the study.
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0015895
UMLS CUI [4]
C0700589
there must be no plans for the patient to receive concomitant antineoplastic therapy while on this protocol.
Description

ID.13

Data type

boolean

Alias
UMLS CUI [1]
C1707479
all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Description

ID.14

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Back to the top of the page

Similar models

Eligibility Colorectal Carcinoma NCT00176774

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
patients must have histologically proven adenocarcinoma primary to the colon or rectum and clinical or pathologic evidence of distant metastasis.
boolean
C0001418 (UMLS CUI [1,1])
C0034896 (UMLS CUI [1,2])
C0001418 (UMLS CUI [1,3])
C0009368 (UMLS CUI [1,4])
C0019638 (UMLS CUI [1,5])
C0027627 (UMLS CUI [2])
ID.2
Item
patients may have received adjuvant chemotherapy and/or one regimen of chemotherapy for metastatic disease. patients must not have been previously treated with the combination of irinotecan/5-fu/lv.
boolean
C0392920 (UMLS CUI [1])
C0123931 (UMLS CUI [2,1])
C0016360 (UMLS CUI [2,2])
C0023413 (UMLS CUI [2,3])
ID.3
Item
patients must be past their 18th birthday at the time of enrollment.
boolean
C0001779 (UMLS CUI [1])
ID.4
Item
patients must have a performance status of 0-2 at the time of registration.
boolean
C1520224 (UMLS CUI [1])
ID.5
Item
patients must have a life expectancy of > 3 months.
boolean
C0023671 (UMLS CUI [1])
ID.6
Item
if patients have undergone recent surgery, they must have fully recovered from the effects of that surgery prior to enrollment.
boolean
C2004454 (UMLS CUI [1])
ID.7
Item
patients must have a pretreatment leukocyte count > 3,000/l, absolute neutrophil count >1500/l, hemoglobin >8 mg/dl, and platelet count of > 150,000/l within 2 weeks of enrollment.
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
ID.8
Item
patients must have adequate renal function, as documented by a serum creatinine < 2.0 mg/dl, and have adequate hepatic function, as documented by a serum bilirubin < 1.1 mg/dl within 2 weeks of enrollment.
boolean
C1278039 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
ID.9
Item
patients must not have active infection.
boolean
C0009450 (UMLS CUI [1])
ID.10
Item
patients must have no serious medical or psychiatric illness, other than that treated by this study, which would limit the ability of the patient to receive protocol therapy or give informed consent.
boolean
C0009488 (UMLS CUI [1])
ID.11
Item
patients must not have a history of active malignancy, other than that treated by this study, within the 12 months preceding enrollment.
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
ID.12
Item
pregnant or lactating women may not participate. women of reproductive age must undergo a serum pregnancy test within 14 days of enrollment. men and women of reproductive potential must use an effective contraceptive method during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0015895 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
ID.13
Item
there must be no plans for the patient to receive concomitant antineoplastic therapy while on this protocol.
boolean
C1707479 (UMLS CUI [1])
ID.14
Item
all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (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