ID

20452

Beschrijving

Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement; ODM derived from: https://clinicaltrials.gov/show/NCT00537823

Link

https://clinicaltrials.gov/show/NCT00537823

Trefwoorden

  1. 22-02-17 22-02-17 -
Geüploaded op

22 februari 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Colorectal Cancer NCT00537823

Eligibility Colorectal Cancer NCT00537823

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
synchronous or metachronous colorectal metastases
Beschrijving

synchronous or metachronous colorectal metastases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009404
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0439580
UMLS CUI [1,4]
C1334703
technically resectable liver metastases
Beschrijving

resectable liver metastases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0494165
UMLS CUI [1,2]
C1514888
four or fewer metastases
Beschrijving

metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
no tumors in porta hepatis
Beschrijving

no tumors in porta hepatis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0227498
UMLS CUI [1,2]
C1269955
resection of no more than 70% of liver needed
Beschrijving

Partial hepatectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0193398
medically suitable candidate for major liver resection
Beschrijving

medically suitable candidate for major liver resection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0193398
UMLS CUI [1,2]
C0332149
fdg-pet scan without metastatic disease outside the liver
Beschrijving

FDG-Positron Emission Tomography | Metastatic Neoplasm | Liver

Datatype

boolean

Alias
UMLS CUI [1]
C3641247
UMLS CUI [2]
C2939420
UMLS CUI [3]
C0023884
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
near-obstructing or obstructing colon lesions in patients in whom combined resection is planned (as delay for preoperative chemotherapy would be medially impossible)
Beschrijving

near-obstructing or obstructing colon lesions

Datatype

boolean

Alias
UMLS CUI [1,1]
C0235328
UMLS CUI [1,2]
C0742597
treatment with folfox or cetuximab within 12 months
Beschrijving

prior therapy, folfox, cetuximab

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0392943
UMLS CUI [3]
C0995188
treatment with irinotecan within 12 months
Beschrijving

prior therapy irinotecan

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0123931
abnormal liver function (alt or ast > 5x uln, bilirubin > 3x uln)
Beschrijving

alt, ast, bilirubin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0201899
UMLS CUI [1,3]
C1278039
body mass index >/= 35 kg/m² (as the risk for steatohepatitis is increased)
Beschrijving

bmi

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
renal insufficiency (cr > 2.5mg/dl)
Beschrijving

creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
interstitial lung disease (because cetuximab has been rarely associated with development of interstitial lung disease)
Beschrijving

interstitial lung disease

Datatype

boolean

Alias
UMLS CUI [1]
C0206062
ecog performance score >/= 3
Beschrijving

ecog

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
patients unable to give informed consent
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
pregnant patient (as cetuximab is a class c drug)
Beschrijving

pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
peripheral neuropathy >/= grade ii (as oxaliplatin causes neuropathy to worsen)
Beschrijving

peripheral neuropathy

Datatype

boolean

Alias
UMLS CUI [1]
C0031117

Similar models

Eligibility Colorectal Cancer NCT00537823

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
synchronous or metachronous colorectal metastases
Item
synchronous or metachronous colorectal metastases
boolean
C0009404 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0439580 (UMLS CUI [1,3])
C1334703 (UMLS CUI [1,4])
resectable liver metastases
Item
technically resectable liver metastases
boolean
C0494165 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
metastasis
Item
four or fewer metastases
boolean
C0027627 (UMLS CUI [1])
no tumors in porta hepatis
Item
no tumors in porta hepatis
boolean
C0227498 (UMLS CUI [1,1])
C1269955 (UMLS CUI [1,2])
Partial hepatectomy
Item
resection of no more than 70% of liver needed
boolean
C0193398 (UMLS CUI [1])
medically suitable candidate for major liver resection
Item
medically suitable candidate for major liver resection
boolean
C0193398 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
FDG-Positron Emission Tomography | Metastatic Neoplasm | Liver
Item
fdg-pet scan without metastatic disease outside the liver
boolean
C3641247 (UMLS CUI [1])
C2939420 (UMLS CUI [2])
C0023884 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
near-obstructing or obstructing colon lesions
Item
near-obstructing or obstructing colon lesions in patients in whom combined resection is planned (as delay for preoperative chemotherapy would be medially impossible)
boolean
C0235328 (UMLS CUI [1,1])
C0742597 (UMLS CUI [1,2])
prior therapy, folfox, cetuximab
Item
treatment with folfox or cetuximab within 12 months
boolean
C1514463 (UMLS CUI [1])
C0392943 (UMLS CUI [2])
C0995188 (UMLS CUI [3])
prior therapy irinotecan
Item
treatment with irinotecan within 12 months
boolean
C1514463 (UMLS CUI [1,1])
C0123931 (UMLS CUI [1,2])
alt, ast, bilirubin
Item
abnormal liver function (alt or ast > 5x uln, bilirubin > 3x uln)
boolean
C0201836 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C1278039 (UMLS CUI [1,3])
bmi
Item
body mass index >/= 35 kg/m² (as the risk for steatohepatitis is increased)
boolean
C1305855 (UMLS CUI [1])
creatinine
Item
renal insufficiency (cr > 2.5mg/dl)
boolean
C0201976 (UMLS CUI [1])
interstitial lung disease
Item
interstitial lung disease (because cetuximab has been rarely associated with development of interstitial lung disease)
boolean
C0206062 (UMLS CUI [1])
ecog
Item
ecog performance score >/= 3
boolean
C1520224 (UMLS CUI [1])
informed consent
Item
patients unable to give informed consent
boolean
C0021430 (UMLS CUI [1])
pregnancy
Item
pregnant patient (as cetuximab is a class c drug)
boolean
C0032961 (UMLS CUI [1])
peripheral neuropathy
Item
peripheral neuropathy >/= grade ii (as oxaliplatin causes neuropathy to worsen)
boolean
C0031117 (UMLS CUI [1])

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