ID

31513

Beskrivning

Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC); ODM derived from: https://clinicaltrials.gov/show/NCT00997685

Länk

https://clinicaltrials.gov/show/NCT00997685

Nyckelord

Versioner (1)
  1. 2018-08-30 2018-08-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 augusti 2018

DOI

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Creative Commons BY 4.0
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Eligibility Potentially Resectable Liver Metastasis From CRC NCT00997685

Engelsk

Eligibility Potentially Resectable Liver Metastasis From CRC NCT00997685

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age of 18 and 65
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis
Beskrivning

Colorectal Carcinoma | Secondary malignant neoplasm of liver Imaging Techniques Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2,1]
C0494165
UMLS CUI [2,2]
C0079595
UMLS CUI [2,3]
C1265611
potentially curable by resection, as determined by a surgeon with hepatic surgery expertise
Beskrivning

Cure of disease Possible | Excision

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679252
UMLS CUI [1,2]
C0332149
UMLS CUI [2]
C0728940
no evidence of extrahepatic disease by chest x-ray or ct scan of the chest, abdomen, and pelvis
Beskrivning

Absence Disease Extrahepatic Chest X-ray | Absence Disease Extrahepatic Chest CT | Absence Disease Extrahepatic X-ray abdomen | Absence Disease Extrahepatic CT of abdomen | Absence Disease Extrahepatic Pelvis X-ray | Absence Disease Extrahepatic CT of Pelvis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1517058
UMLS CUI [1,4]
C0039985
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C1517058
UMLS CUI [2,4]
C0202823
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C1517058
UMLS CUI [3,4]
C0581165
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C1517058
UMLS CUI [4,4]
C0412620
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C1517058
UMLS CUI [5,4]
C0554740
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C1517058
UMLS CUI [6,4]
C0412628
patients with adequate hepative, renal and bone marrow function
Beskrivning

Liver function | Renal function | Bone Marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
signed written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing patients (fertile patients must use effective contraception)
Beskrivning

Pregnancy | Breast Feeding | Fertility Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0015895
UMLS CUI [3,2]
C0700589
other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix
Beskrivning

Cancer Other | Exception Complete excision Skin carcinoma | Exception Complete excision Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015250
UMLS CUI [2,3]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0015250
UMLS CUI [3,3]
C0851140
preexisting grade 2 or greater peripheral neuropathy
Beskrivning

Peripheral Neuropathy Pre-existing CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
concurrent uncontrolled illness
Beskrivning

Comorbidity Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
ongoing or active infection
Beskrivning

Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
psychiatric illness or social situation that would preclude study compliance
Beskrivning

Mental disorders Exclude Protocol Compliance | Social situation Excludes Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
less than 6 months since prior adjuvant fluorouracil-based chemotherapy
Beskrivning

Chemotherapy, Adjuvant | Fluorouracil

Datatyp

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2]
C0016360
prior chemotherapy for liver metastasis
Beskrivning

Prior Chemotherapy Secondary malignant neoplasm of liver

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0494165
prior oxaliplatin for colorectal cancer
Beskrivning

Oxaliplatin | Colorectal Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0069717
UMLS CUI [2]
C0009402
prior or concurrent hepatic artery infusion chemotherapy for metastatic disease
Beskrivning

Hepatic Artery Infusion Chemotherapy Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1134564
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0027627
prior or concurrent radiotherapy for metastatic disease
Beskrivning

Therapeutic radiology procedure Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0027627
prior or concurrent radiofrequency ablation for metastatic disease
Beskrivning

Radiofrequency ablation Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0850292
UMLS CUI [1,2]
C0027627
concurrent treatment with any other anti-cancer therapy.
Beskrivning

Cancer treatment Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility Potentially Resectable Liver Metastasis From CRC NCT00997685

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age of 18 and 65
boolean
C0001779 (UMLS CUI [1])
Colorectal Carcinoma | Secondary malignant neoplasm of liver Imaging Techniques Quantity
Item
histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis
boolean
C0009402 (UMLS CUI [1])
C0494165 (UMLS CUI [2,1])
C0079595 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Cure of disease Possible | Excision
Item
potentially curable by resection, as determined by a surgeon with hepatic surgery expertise
boolean
C0679252 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2])
Absence Disease Extrahepatic Chest X-ray | Absence Disease Extrahepatic Chest CT | Absence Disease Extrahepatic X-ray abdomen | Absence Disease Extrahepatic CT of abdomen | Absence Disease Extrahepatic Pelvis X-ray | Absence Disease Extrahepatic CT of Pelvis
Item
no evidence of extrahepatic disease by chest x-ray or ct scan of the chest, abdomen, and pelvis
boolean
C0332197 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,3])
C0039985 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C1517058 (UMLS CUI [2,3])
C0202823 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C1517058 (UMLS CUI [3,3])
C0581165 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C1517058 (UMLS CUI [4,3])
C0412620 (UMLS CUI [4,4])
C0332197 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C1517058 (UMLS CUI [5,3])
C0554740 (UMLS CUI [5,4])
C0332197 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C1517058 (UMLS CUI [6,3])
C0412628 (UMLS CUI [6,4])
Liver function | Renal function | Bone Marrow function
Item
patients with adequate hepative, renal and bone marrow function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Fertility Contraceptive methods
Item
pregnant or nursing patients (fertile patients must use effective contraception)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0015895 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Cancer Other | Exception Complete excision Skin carcinoma | Exception Complete excision Carcinoma in situ of uterine cervix
Item
other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015250 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0015250 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
preexisting grade 2 or greater peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Comorbidity Uncontrolled
Item
concurrent uncontrolled illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Communicable Disease
Item
ongoing or active infection
boolean
C0009450 (UMLS CUI [1])
Mental disorders Exclude Protocol Compliance | Social situation Excludes Protocol Compliance
Item
psychiatric illness or social situation that would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Chemotherapy, Adjuvant | Fluorouracil
Item
less than 6 months since prior adjuvant fluorouracil-based chemotherapy
boolean
C0085533 (UMLS CUI [1])
C0016360 (UMLS CUI [2])
Prior Chemotherapy Secondary malignant neoplasm of liver
Item
prior chemotherapy for liver metastasis
boolean
C1514457 (UMLS CUI [1,1])
C0494165 (UMLS CUI [1,2])
Oxaliplatin | Colorectal Carcinoma
Item
prior oxaliplatin for colorectal cancer
boolean
C0069717 (UMLS CUI [1])
C0009402 (UMLS CUI [2])
Hepatic Artery Infusion Chemotherapy Neoplasm Metastasis
Item
prior or concurrent hepatic artery infusion chemotherapy for metastatic disease
boolean
C1134564 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Therapeutic radiology procedure Neoplasm Metastasis
Item
prior or concurrent radiotherapy for metastatic disease
boolean
C1522449 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Radiofrequency ablation Neoplasm Metastasis
Item
prior or concurrent radiofrequency ablation for metastatic disease
boolean
C0850292 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Cancer treatment Other
Item
concurrent treatment with any other anti-cancer therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Tillbaka till toppen 

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