ID

23729

Description

Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00689624

Link

https://clinicaltrials.gov/show/NCT00689624

Keywords

Versions (1)
  1. 7/12/17 7/12/17 - Julian Varghese
Uploaded on

July 12, 2017

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility Metastatic Colorectal Cancer NCT00689624

English

Eligibility Metastatic Colorectal Cancer NCT00689624

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically proven metastatic adenocarcinoma of the colon or rectum
Description

metastatic adenocarcinoma of the colon or rectum

Data type

boolean

Alias
UMLS CUI [1,1]
C0338106
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C0027627
previous chemotherapy for metastatic disease not allowed. patients who received prior adjuvant 5-fu-based chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy
Description

fu-based chemotherapy and free of disease for at least 6 months

Data type

boolean

Alias
UMLS CUI [1,1]
C0016360
UMLS CUI [1,2]
C2919733
patients with operable metastatic disease are excluded from the study
Description

operable metastatic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205188
age 18-70 years
Description

age

Data type

boolean

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

eco performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
at least one bidimensionally measurable lesion of >= 2cm
Description

bidimensionally measurable lesion

Data type

boolean

Alias
UMLS CUI [1]
C0221198
life expectancy of at least 6 months
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate hematologic parameters (absolute neutrophil count >= 1.5x109/l and platelets >=100x109/l)
Description

Absolute neutrophil count Blood Platelets

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
creatinine and total bilirubin < 1.25 times the upper limit of normal
Description

creatinine and total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201913
aspartate and alanine aminotransferase < 3.0 times the upper limit of normal (<5 times in case of liver mets)
Description

aspartate and alanine aminotransferase

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
absence of active infection or malnutrition (loss of more than 20% of the body weight)
Description

active infection or malnutrition

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0162429
no history of a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma. curatively treated
Description

no history of a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma. curatively treated

Data type

boolean

Alias
UMLS CUI [1,1]
C0085183
UMLS CUI [1,2]
C0007114
UMLS CUI [1,3]
C0184780
UMLS CUI [2,1]
C0851140
UMLS CUI [2,2]
C0184780
patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields.
Description

palliative radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C3898008
patients with severe cardiac dysfunction, liver metastases involving more than 50% of the liver parenchyma, chronic diarrhea, or prior irradiation affecting more than 30% of the active bone marrow are excluded.
Description

cardiac dysfunction, liver metastases involving more than 50%, chronic diarrhea, or irradiation of 30% of bone marrow

Data type

boolean

Alias
UMLS CUI [1]
C3277906
UMLS CUI [2]
C3494607
UMLS CUI [3]
C0401151
UMLS CUI [4]
C0436251
all patients will have to sign written informed consent in order to participate in the study
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Metastatic Colorectal Cancer NCT00689624

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
metastatic adenocarcinoma of the colon or rectum
Item
patients with histologically proven metastatic adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0149978 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
fu-based chemotherapy and free of disease for at least 6 months
Item
previous chemotherapy for metastatic disease not allowed. patients who received prior adjuvant 5-fu-based chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy
boolean
C0016360 (UMLS CUI [1,1])
C2919733 (UMLS CUI [1,2])
operable metastatic disease
Item
patients with operable metastatic disease are excluded from the study
boolean
C0027627 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
age
Item
age 18-70 years
boolean
C0001779 (UMLS CUI [1])
eco performance status
Item
performance status (ecog) 0-1
boolean
C1520224 (UMLS CUI [1])
bidimensionally measurable lesion
Item
at least one bidimensionally measurable lesion of >= 2cm
boolean
C0221198 (UMLS CUI [1])
life expectancy
Item
life expectancy of at least 6 months
boolean
C0023671 (UMLS CUI [1])
Absolute neutrophil count Blood Platelets
Item
adequate hematologic parameters (absolute neutrophil count >= 1.5x109/l and platelets >=100x109/l)
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
creatinine and total bilirubin
Item
creatinine and total bilirubin < 1.25 times the upper limit of normal
boolean
C0201976 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
aspartate and alanine aminotransferase
Item
aspartate and alanine aminotransferase < 3.0 times the upper limit of normal (<5 times in case of liver mets)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
active infection or malnutrition
Item
absence of active infection or malnutrition (loss of more than 20% of the body weight)
boolean
C0009450 (UMLS CUI [1])
C0162429 (UMLS CUI [2])
no history of a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma. curatively treated
Item
no history of a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma. curatively treated
boolean
C0085183 (UMLS CUI [1,1])
C0007114 (UMLS CUI [1,2])
C0184780 (UMLS CUI [1,3])
C0851140 (UMLS CUI [2,1])
C0184780 (UMLS CUI [2,2])
palliative radiotherapy
Item
patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields.
boolean
C3898008 (UMLS CUI [1])
cardiac dysfunction, liver metastases involving more than 50%, chronic diarrhea, or irradiation of 30% of bone marrow
Item
patients with severe cardiac dysfunction, liver metastases involving more than 50% of the liver parenchyma, chronic diarrhea, or prior irradiation affecting more than 30% of the active bone marrow are excluded.
boolean
C3277906 (UMLS CUI [1])
C3494607 (UMLS CUI [2])
C0401151 (UMLS CUI [3])
C0436251 (UMLS CUI [4])
informed consent
Item
all patients will have to sign written informed consent in order to participate in the study
boolean
C0021430 (UMLS CUI [1])
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