ID

28151

Beskrivning

Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT00594529

Länk

https://clinicaltrials.gov/show/NCT00594529

Nyckelord

Versioner (1)
  1. 2017-12-22 2017-12-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 december 2017

DOI

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Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00594529

Engelsk

Eligibility Colorectal Cancer NCT00594529

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal, and anal canal cancers.
Beskrivning

Colorectal adenocarcinoma | Cecum Carcinoma | Malignant neoplasm of appendix | Malignant neoplasm of anal canal

Datatyp

boolean

Alias
UMLS CUI [1]
C1319315
UMLS CUI [2]
C0149640
UMLS CUI [3]
C0496779
UMLS CUI [4]
C0153445
2. liver lesions are measurable by spiral ct or spio-mri scans.
Beskrivning

Lesion of liver Spiral CT | Lesion of liver SPIO-MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0860888
UMLS CUI [2,1]
C0577053
UMLS CUI [2,2]
C3896586
3. extrahepatic lesions include lung metastases which can be resected curatively.
Beskrivning

Lesion Extrahepatic | Secondary malignant neoplasm of lung Resectable Curative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1517058
UMLS CUI [2,1]
C0153676
UMLS CUI [2,2]
C1514888
UMLS CUI [2,3]
C1276305
4. curative resection for metastatic lesions can be performed with residual hepatic functions preserved.
Beskrivning

Excision Curative Metastatic Lesion | Liver function Residual

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C1276305
UMLS CUI [1,3]
C1513183
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C1609982
5. no prior treatment histories for liver lesions, including l-ohp regimens, hepatectomy, hepatic arterial infusion, mct, or rfa
Beskrivning

Absence Prior Therapy Lesion of liver | Oxaliplatin Absent | Hepatectomy Absent | Hepatic arterial infusion Absent | Medium chain triglycerides Absent | Radiofrequency ablation Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0577053
UMLS CUI [2,1]
C0069717
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0019144
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1134564
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0724624
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0850292
UMLS CUI [6,2]
C0332197
6. no evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection
Beskrivning

Absence Chronic liver disease Affecting Systemic Chemotherapy | Absence Chronic liver disease Affecting Excision

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0341439
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C1883256
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0341439
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0728940
7. performance status (ecog): 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
8. vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved.
Beskrivning

Organ function | Function Hematopoietic | Cardiac function | Respiratory function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0031843
UMLS CUI [2,2]
C0229601
UMLS CUI [3]
C0232164
UMLS CUI [4]
C0035203
UMLS CUI [5]
C0232804
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
excluded are cases with conditions as below:
Beskrivning

Condition Specified

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205369
1. peritoneal or pleural fluid retention to be drained.
Beskrivning

Fluid retention peritoneal Requirement Drainage | Fluid retention Pleural Requirement Drainage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0268000
UMLS CUI [1,2]
C0442034
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0013103
UMLS CUI [2,1]
C0268000
UMLS CUI [2,2]
C1522720
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0013103
2. multiple malignancies to be treated.
Beskrivning

Multiple malignancy Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0346429
UMLS CUI [1,2]
C0332121
3. peripheral neural disturbances.
Beskrivning

Peripheral Neuropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0031117
4. active infectious diseases.
Beskrivning

Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
5. severe watery diarrhea.
Beskrivning

Watery diarrhoea Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0239182
UMLS CUI [1,2]
C0205082
6. mental disturbances.
Beskrivning

Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
7. treatment history of continuous, oral or intravenous steroid therapy.
Beskrivning

Oral steroid therapy | Steroid therapy Intravenous

Datatyp

boolean

Alias
UMLS CUI [1]
C0574135
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0348016
8. previous history of ischemic heart diseases.
Beskrivning

Myocardial Ischemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0151744
9. coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure.
Beskrivning

Comorbidity Severe | Pulmonary Fibrosis | Pneumonia, Interstitial | Ileus | Diabetic - poor control | Cardiac dysfunction | Liver Failure | Kidney Failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0034069
UMLS CUI [3]
C0206061
UMLS CUI [4]
C1258215
UMLS CUI [5]
C0421258
UMLS CUI [6]
C3277906
UMLS CUI [7]
C0085605
UMLS CUI [8]
C0035078
10. pregnant.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
11. previous history of severe drug-induced allergy.
Beskrivning

Severe allergy Drug-induced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0458082
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Similar models

Eligibility Colorectal Cancer NCT00594529

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal adenocarcinoma | Cecum Carcinoma | Malignant neoplasm of appendix | Malignant neoplasm of anal canal
Item
1. histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal, and anal canal cancers.
boolean
C1319315 (UMLS CUI [1])
C0149640 (UMLS CUI [2])
C0496779 (UMLS CUI [3])
C0153445 (UMLS CUI [4])
Lesion of liver Spiral CT | Lesion of liver SPIO-MRI
Item
2. liver lesions are measurable by spiral ct or spio-mri scans.
boolean
C0577053 (UMLS CUI [1,1])
C0860888 (UMLS CUI [1,2])
C0577053 (UMLS CUI [2,1])
C3896586 (UMLS CUI [2,2])
Lesion Extrahepatic | Secondary malignant neoplasm of lung Resectable Curative
Item
3. extrahepatic lesions include lung metastases which can be resected curatively.
boolean
C0221198 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0153676 (UMLS CUI [2,1])
C1514888 (UMLS CUI [2,2])
C1276305 (UMLS CUI [2,3])
Excision Curative Metastatic Lesion | Liver function Residual
Item
4. curative resection for metastatic lesions can be performed with residual hepatic functions preserved.
boolean
C0728940 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
C1513183 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C1609982 (UMLS CUI [2,2])
Absence Prior Therapy Lesion of liver | Oxaliplatin Absent | Hepatectomy Absent | Hepatic arterial infusion Absent | Medium chain triglycerides Absent | Radiofrequency ablation Absent
Item
5. no prior treatment histories for liver lesions, including l-ohp regimens, hepatectomy, hepatic arterial infusion, mct, or rfa
boolean
C0332197 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0577053 (UMLS CUI [1,3])
C0069717 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019144 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1134564 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0724624 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0850292 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Absence Chronic liver disease Affecting Systemic Chemotherapy | Absence Chronic liver disease Affecting Excision
Item
6. no evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection
boolean
C0332197 (UMLS CUI [1,1])
C0341439 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C1883256 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0341439 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0728940 (UMLS CUI [2,4])
ECOG performance status
Item
7. performance status (ecog): 0-1
boolean
C1520224 (UMLS CUI [1])
Organ function | Function Hematopoietic | Cardiac function | Respiratory function | Renal function
Item
8. vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved.
boolean
C0678852 (UMLS CUI [1])
C0031843 (UMLS CUI [2,1])
C0229601 (UMLS CUI [2,2])
C0232164 (UMLS CUI [3])
C0035203 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Condition Specified
Item
excluded are cases with conditions as below:
boolean
C0348080 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Fluid retention peritoneal Requirement Drainage | Fluid retention Pleural Requirement Drainage
Item
1. peritoneal or pleural fluid retention to be drained.
boolean
C0268000 (UMLS CUI [1,1])
C0442034 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0013103 (UMLS CUI [1,4])
C0268000 (UMLS CUI [2,1])
C1522720 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0013103 (UMLS CUI [2,4])
Multiple malignancy Treatment required for
Item
2. multiple malignancies to be treated.
boolean
C0346429 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Peripheral Neuropathy
Item
3. peripheral neural disturbances.
boolean
C0031117 (UMLS CUI [1])
Communicable Disease
Item
4. active infectious diseases.
boolean
C0009450 (UMLS CUI [1])
Watery diarrhoea Severe
Item
5. severe watery diarrhea.
boolean
C0239182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Mental disorders
Item
6. mental disturbances.
boolean
C0004936 (UMLS CUI [1])
Oral steroid therapy | Steroid therapy Intravenous
Item
7. treatment history of continuous, oral or intravenous steroid therapy.
boolean
C0574135 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0348016 (UMLS CUI [2,2])
Myocardial Ischemia
Item
8. previous history of ischemic heart diseases.
boolean
C0151744 (UMLS CUI [1])
Comorbidity Severe | Pulmonary Fibrosis | Pneumonia, Interstitial | Ileus | Diabetic - poor control | Cardiac dysfunction | Liver Failure | Kidney Failure
Item
9. coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0034069 (UMLS CUI [2])
C0206061 (UMLS CUI [3])
C1258215 (UMLS CUI [4])
C0421258 (UMLS CUI [5])
C3277906 (UMLS CUI [6])
C0085605 (UMLS CUI [7])
C0035078 (UMLS CUI [8])
Pregnancy
Item
10. pregnant.
boolean
C0032961 (UMLS CUI [1])
Severe allergy Drug-induced
Item
11. previous history of severe drug-induced allergy.
boolean
C2945656 (UMLS CUI [1,1])
C0458082 (UMLS CUI [1,2])
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