ID

21438

Descrição

Capecitabine and Oxaliplatin Plus Bevacizumab as Neoadjuvant Treatment for Untreated Unresectable Liver-only Metastases From Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01022541

Link

https://clinicaltrials.gov/show/NCT01022541

Palavras-chave

Versões (1)
  1. 21/04/2017 21/04/2017 -
Transferido a

21 de abril de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT01022541

Inglês

Eligibility Metastatic Colorectal Cancer NCT01022541

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven diagnosis of colorectal adenocarcinoma
Descrição

Colorectal adenocarcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1319315
metastatic disease present in the liver only.
Descrição

Liver metastases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0494165
absence of extrahepatic metastases excluded by ct chest, abdomen and pelvis. indeterminate ct findings may require verification by fdg-pet scanning.
Descrição

Chest, abdomen, pelvis CT

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0202823
UMLS CUI [2]
C0412620
UMLS CUI [3]
C0412628
liver-only metastases determined to be unresectable at presentation on a pre-treatment liver mri with an appropriate liver specific contrast (eg. tesla) by a specialist multidisciplinary team (consisting of medical oncologist, hepatic surgeon and radiologist). guidelines for determining unresectability include:
Descrição

Unresectable liver metastases

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1519810
UMLS CUI [1,2]
C0494165
presence of >4 metastases;
Descrição

Number of metastases

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0027627
size >5cm;
Descrição

Size of metastases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1300989
location and distribution of metastatic disease within the liver unsuitable for resection with clear margins (eg. involvement of both lobes of liver; invasion of intrahepatic vascular structures);
Descrição

Location and distribution of metastatic disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C1704711
UMLS CUI [2,2]
C0027627
extent of liver involvement precluding resection with adequate post-resection residual liver parenchyma volume for viable liver function in the immediate post-operative period;
Descrição

Extent of liver involvement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0439792
UMLS CUI [1,2]
C0449625
inability to retain adequate vascular in flow and out flow to maintain viable liver function.
Descrição

Liver vascular flow

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0232338
UMLS CUI [1,2]
C0023884
no previous treatment for metastatic colorectal cancer, including chemotherapy, targeted or experimental therapies (e.g. anti-vegf or anti-egfr), radiotherapy to the liver, or surgery or radiofrequency ablation to liver metastases.
Descrição

Prior therapy for metastatic colorectal cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0948380
feasibility of surgery with curative intent:
Descrição

Operable with curative intent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205188
UMLS CUI [1,2]
C1276305
if the primary colorectal tumour is in situ, the primary tumour must also be resectable with curative intent
Descrição

Resectable primary tumor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514888
UMLS CUI [1,2]
C0677930
patients presenting with liver metastases only relapse after initially curative resection of their primary colorectal cancer followed by treatment with adjuvant chemotherapy may not be entered into the study if the relapse has occurred within 12 months of completion of adjuvant treatment
Descrição

Relapse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0277556
adequate medical fitness to undergo neoadjuvant treatment and surgery with curative intent (hepatectomy +/- resection of primary tumour, if required)
Descrição

Health status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018759
absence of pre-existing liver dysfunction of childs pugh grade b or greater. patients who are suspected of having pre-existing liver dysfunction due to clinical, biochemical or radiological findings, should have significant liver disease excluded by a liver biopsy prior to study entry.
Descrição

Liver function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
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Similar models

Eligibility Metastatic Colorectal Cancer NCT01022541

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal adenocarcinoma
Item
histologically proven diagnosis of colorectal adenocarcinoma
boolean
C1319315 (UMLS CUI [1])
Liver metastases
Item
metastatic disease present in the liver only.
boolean
C0494165 (UMLS CUI [1])
Chest, abdomen, pelvis CT
Item
absence of extrahepatic metastases excluded by ct chest, abdomen and pelvis. indeterminate ct findings may require verification by fdg-pet scanning.
boolean
C0202823 (UMLS CUI [1])
C0412620 (UMLS CUI [2])
C0412628 (UMLS CUI [3])
Unresectable liver metastases
Item
liver-only metastases determined to be unresectable at presentation on a pre-treatment liver mri with an appropriate liver specific contrast (eg. tesla) by a specialist multidisciplinary team (consisting of medical oncologist, hepatic surgeon and radiologist). guidelines for determining unresectability include:
boolean
C1519810 (UMLS CUI [1,1])
C0494165 (UMLS CUI [1,2])
Number of metastases
Item
presence of >4 metastases;
boolean
C0449788 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Size of metastases
Item
size >5cm;
boolean
C1300989 (UMLS CUI [1])
Location and distribution of metastatic disease
Item
location and distribution of metastatic disease within the liver unsuitable for resection with clear margins (eg. involvement of both lobes of liver; invasion of intrahepatic vascular structures);
boolean
C1515974 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1704711 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Extent of liver involvement
Item
extent of liver involvement precluding resection with adequate post-resection residual liver parenchyma volume for viable liver function in the immediate post-operative period;
boolean
C0439792 (UMLS CUI [1,1])
C0449625 (UMLS CUI [1,2])
Liver vascular flow
Item
inability to retain adequate vascular in flow and out flow to maintain viable liver function.
boolean
C0232338 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Prior therapy for metastatic colorectal cancer
Item
no previous treatment for metastatic colorectal cancer, including chemotherapy, targeted or experimental therapies (e.g. anti-vegf or anti-egfr), radiotherapy to the liver, or surgery or radiofrequency ablation to liver metastases.
boolean
C1514463 (UMLS CUI [1,1])
C0948380 (UMLS CUI [1,2])
Operable with curative intent
Item
feasibility of surgery with curative intent:
boolean
C0205188 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
Resectable primary tumor
Item
if the primary colorectal tumour is in situ, the primary tumour must also be resectable with curative intent
boolean
C1514888 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
Relapse
Item
patients presenting with liver metastases only relapse after initially curative resection of their primary colorectal cancer followed by treatment with adjuvant chemotherapy may not be entered into the study if the relapse has occurred within 12 months of completion of adjuvant treatment
boolean
C0277556 (UMLS CUI [1])
Health status
Item
adequate medical fitness to undergo neoadjuvant treatment and surgery with curative intent (hepatectomy +/- resection of primary tumour, if required)
boolean
C0018759 (UMLS CUI [1])
Liver function
Item
absence of pre-existing liver dysfunction of childs pugh grade b or greater. patients who are suspected of having pre-existing liver dysfunction due to clinical, biochemical or radiological findings, should have significant liver disease excluded by a liver biopsy prior to study entry.
boolean
C0232741 (UMLS CUI [1])
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