ID

20452

Descripción

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

Palabras clave

Versiones (1)
  1. 22/2/17 22/2/17 -
Subido en

22 de febrero de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00537823

Inglés

Eligibility Colorectal Cancer NCT00537823

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
synchronous or metachronous colorectal metastases
Descripción

synchronous or metachronous colorectal metastases

Tipo de datos

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
Descripción

resectable liver metastases

Tipo de datos

boolean

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

metastasis

Tipo de datos

boolean

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

no tumors in porta hepatis

Tipo de datos

boolean

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

Partial hepatectomy

Tipo de datos

boolean

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

medically suitable candidate for major liver resection

Tipo de datos

boolean

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

FDG-Positron Emission Tomography | Metastatic Neoplasm | Liver

Tipo de datos

boolean

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

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)
Descripción

near-obstructing or obstructing colon lesions

Tipo de datos

boolean

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

prior therapy, folfox, cetuximab

Tipo de datos

boolean

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

prior therapy irinotecan

Tipo de datos

boolean

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

alt, ast, bilirubin

Tipo de datos

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)
Descripción

bmi

Tipo de datos

boolean

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

creatinine

Tipo de datos

boolean

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

interstitial lung disease

Tipo de datos

boolean

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

ecog

Tipo de datos

boolean

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

informed consent

Tipo de datos

boolean

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

pregnancy

Tipo de datos

boolean

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

peripheral neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031117
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Similar models

Eligibility Colorectal Cancer NCT00537823

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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