ID

16743

Beschrijving

Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00059930

Link

https://clinicaltrials.gov/show/NCT00059930

Trefwoorden

Versies (1)
  1. 03-08-16 03-08-16 -
Geüploaded op

3 augustus 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00059930

Engels

Eligibility Colorectal Cancer NCT00059930

1 Formulieren  
Criteria
Beschrijving

Criteria

history of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. confirmation of diagnosis must be performed at mskcc.
Beschrijving

Adenocarcinoma of large intestine | Secondary malignant neoplasm of liver | Disease Extrahepatic Evidence

Datatype

boolean

Alias
UMLS CUI [1]
C1319315
UMLS CUI [2]
C0494165
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1517058
UMLS CUI [3,3]
C3887511
potentially completely resectable hepatic metastases without current evidence of other metastatic disease.
Beschrijving

Secondary malignant neoplasm of liver Resectable Completely | Neoplasm Metastasis Evidence

Datatype

boolean

Alias
UMLS CUI [1,1]
C0494165
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C3887511
abdominal and pelvic ct scans and chest ct or x-ray within 6 weeks prior to registration. (mri of abdomen may be substituted for ct of abdomen.)
Beschrijving

CT of abdomen | Computed Tomography (CT) of Pelvis | Chest CT | Plain chest X-ray | Magnetic resonance imaging of abdomen

Datatype

boolean

Alias
UMLS CUI [1]
C0412620
UMLS CUI [2]
C0412628
UMLS CUI [3]
C0202823
UMLS CUI [4]
C0039985
UMLS CUI [5]
C0412693
lab values within 14 days prior to registration:
Beschrijving

Laboratory Results

Datatype

boolean

Alias
UMLS CUI [1]
C1254595
wbc ≥ 3.0 k/ul
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
anc >1.5 k/ul
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelets ≥ 100 k/ul
Beschrijving

Blood Platelets

Datatype

boolean

Alias
UMLS CUI [1]
C0005821
total bilirubin ≤ 1.5 mg/dl.
Beschrijving

Bilirubin, total measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201913
prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration to this study.
Beschrijving

Prior Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
kps ≥ 60%
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
signed informed consent.
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
subject exclusion criteria:
Beschrijving

ID.12

Datatype

boolean

prior radiation to the liver. (prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration.)
Beschrijving

radiation of the liver | Therapeutic radiology procedure Pelvis

Datatype

boolean

Alias
UMLS CUI [1]
C3162254
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0030797
active infection, ascites, hepatic encephalopathy
Beschrijving

Communicable Diseases | Ascites | Hepatic Encephalopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0019151
prior oxaliplatin or cisplatin or hai fudr
Beschrijving

oxaliplatin | Cisplatin | hepatic arterial infusion Floxuridine

Datatype

boolean

Alias
UMLS CUI [1]
C0069717
UMLS CUI [2]
C0008838
UMLS CUI [3,1]
C1134564
UMLS CUI [3,2]
C0016343
female patients who are pregnant or lactating
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Colorectal Cancer NCT00059930

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Adenocarcinoma of large intestine | Secondary malignant neoplasm of liver | Disease Extrahepatic Evidence
Item
history of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. confirmation of diagnosis must be performed at mskcc.
boolean
C1319315 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C1517058 (UMLS CUI [3,2])
C3887511 (UMLS CUI [3,3])
Secondary malignant neoplasm of liver Resectable Completely | Neoplasm Metastasis Evidence
Item
potentially completely resectable hepatic metastases without current evidence of other metastatic disease.
boolean
C0494165 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
CT of abdomen | Computed Tomography (CT) of Pelvis | Chest CT | Plain chest X-ray | Magnetic resonance imaging of abdomen
Item
abdominal and pelvic ct scans and chest ct or x-ray within 6 weeks prior to registration. (mri of abdomen may be substituted for ct of abdomen.)
boolean
C0412620 (UMLS CUI [1])
C0412628 (UMLS CUI [2])
C0202823 (UMLS CUI [3])
C0039985 (UMLS CUI [4])
C0412693 (UMLS CUI [5])
Laboratory Results
Item
lab values within 14 days prior to registration:
boolean
C1254595 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc ≥ 3.0 k/ul
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
anc >1.5 k/ul
boolean
C0948762 (UMLS CUI [1])
Blood Platelets
Item
platelets ≥ 100 k/ul
boolean
C0005821 (UMLS CUI [1])
Bilirubin, total measurement
Item
total bilirubin ≤ 1.5 mg/dl.
boolean
C0201913 (UMLS CUI [1])
Prior Chemotherapy
Item
prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration to this study.
boolean
C1514457 (UMLS CUI [1])
Karnofsky Performance Status
Item
kps ≥ 60%
boolean
C0206065 (UMLS CUI [1])
Informed consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
ID.12
Item
subject exclusion criteria:
boolean
radiation of the liver | Therapeutic radiology procedure Pelvis
Item
prior radiation to the liver. (prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration.)
boolean
C3162254 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0030797 (UMLS CUI [2,2])
Communicable Diseases | Ascites | Hepatic Encephalopathy
Item
active infection, ascites, hepatic encephalopathy
boolean
C0009450 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
oxaliplatin | Cisplatin | hepatic arterial infusion Floxuridine
Item
prior oxaliplatin or cisplatin or hai fudr
boolean
C0069717 (UMLS CUI [1])
C0008838 (UMLS CUI [2])
C1134564 (UMLS CUI [3,1])
C0016343 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
female patients who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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