ID

23729

Beschrijving

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

Trefwoorden

Versies (1)
  1. 12-07-17 12-07-17 - Julian Varghese
Geüploaded op

12 juli 2017

DOI

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Licentie

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

Engels

Eligibility Metastatic Colorectal Cancer NCT00689624

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

metastatic adenocarcinoma of the colon or rectum

Datatype

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
Beschrijving

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

Datatype

boolean

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

operable metastatic disease

Datatype

boolean

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

age

Datatype

boolean

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

eco performance status

Datatype

boolean

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

bidimensionally measurable lesion

Datatype

boolean

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

life expectancy

Datatype

boolean

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

Absolute neutrophil count Blood Platelets

Datatype

boolean

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

creatinine and total bilirubin

Datatype

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)
Beschrijving

aspartate and alanine aminotransferase

Datatype

boolean

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

Exclusion Criteria

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

active infection or malnutrition

Datatype

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
Beschrijving

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

Datatype

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.
Beschrijving

palliative radiotherapy

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Metastatic Colorectal Cancer NCT00689624

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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