ID

21438

Description

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

Keywords

Versions (1)
  1. 4/21/17 4/21/17 -
Uploaded on

April 21, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT01022541

English

Eligibility Metastatic Colorectal Cancer NCT01022541

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven diagnosis of colorectal adenocarcinoma
Description

Colorectal adenocarcinoma

Data type

boolean

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

Liver metastases

Data type

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.
Description

Chest, abdomen, pelvis CT

Data type

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:
Description

Unresectable liver metastases

Data type

boolean

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

Number of metastases

Data type

boolean

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

Size of metastases

Data type

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);
Description

Location and distribution of metastatic disease

Data type

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;
Description

Extent of liver involvement

Data type

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.
Description

Liver vascular flow

Data type

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.
Description

Prior therapy for metastatic colorectal cancer

Data type

boolean

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

Operable with curative intent

Data type

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
Description

Resectable primary tumor

Data type

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
Description

Relapse

Data type

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)
Description

Health status

Data type

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.
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
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Similar models

Eligibility Metastatic Colorectal Cancer NCT01022541

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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