ID

35467

Description

Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02376452

Link

https://clinicaltrials.gov/show/NCT02376452

Keywords

Versions (1)
  1. 3/5/19 3/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Carcinoma NCT02376452

English

Eligibility Colorectal Carcinoma NCT02376452

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
Description

Age | Adenocarcinoma of large intestine Advanced

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1319315
UMLS CUI [2,2]
C0205179
eastern cooperative oncology group performance status of 0 to 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of ≥ 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients who had failed first-line treatment with either xelox (capecitabine combined with oxaliplatin) or folfox (5-fluorouracil/leucovorin with oxaliplatin)
Description

First line treatment failed | Xeloda-Oxaliplatin Regimen | FOLFOX Regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C1956962
UMLS CUI [3]
C0392943
at least one measurable disease lesion according to the response evaluation criteria in solid tumors (recist 1.1) criteria
Description

Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
have adequate bone marrow, hepatic, and renal function
Description

Bone Marrow function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
Description

Chronic inflammatory bowel disease | Chronic diarrhea | Intestinal Obstruction Recurrent

Data type

boolean

Alias
UMLS CUI [1]
C1856359
UMLS CUI [2]
C0401151
UMLS CUI [3,1]
C0021843
UMLS CUI [3,2]
C2945760
patients with symptomatic brain metastases
Description

Metastatic malignant neoplasm to brain Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
active clinical severe infection
Description

Communicable Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
previously received irinotecan or raltitrexed
Description

irinotecan | raltitrexed

Data type

boolean

Alias
UMLS CUI [1]
C0123931
UMLS CUI [2]
C0677667
dihydropyrimidine dehydrogenase (dpd) enzyme adequate
Description

Dihydropyrimidine dehydrogenase Adequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0058126
UMLS CUI [1,2]
C0205411
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Similar models

Eligibility Colorectal Carcinoma NCT02376452

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Adenocarcinoma of large intestine Advanced
Item
aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
boolean
C0001779 (UMLS CUI [1])
C1319315 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
First line treatment failed | Xeloda-Oxaliplatin Regimen | FOLFOX Regimen
Item
patients who had failed first-line treatment with either xelox (capecitabine combined with oxaliplatin) or folfox (5-fluorouracil/leucovorin with oxaliplatin)
boolean
C1708063 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1956962 (UMLS CUI [2])
C0392943 (UMLS CUI [3])
Measurable lesion Quantity
Item
at least one measurable disease lesion according to the response evaluation criteria in solid tumors (recist 1.1) criteria
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Bone Marrow function | Liver function | Renal function
Item
have adequate bone marrow, hepatic, and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Chronic inflammatory bowel disease | Chronic diarrhea | Intestinal Obstruction Recurrent
Item
patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
boolean
C1856359 (UMLS CUI [1])
C0401151 (UMLS CUI [2])
C0021843 (UMLS CUI [3,1])
C2945760 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain Symptomatic
Item
patients with symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Communicable Disease Severe
Item
active clinical severe infection
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
irinotecan | raltitrexed
Item
previously received irinotecan or raltitrexed
boolean
C0123931 (UMLS CUI [1])
C0677667 (UMLS CUI [2])
Dihydropyrimidine dehydrogenase Adequate
Item
dihydropyrimidine dehydrogenase (dpd) enzyme adequate
boolean
C0058126 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
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