ID

41148

Descripción

Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01763450

Link

https://clinicaltrials.gov/show/NCT01763450

Palabras clave

Versiones (1)
  1. 1/7/20 1/7/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

1 de julio de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Liver Metastases NCT01763450

Inglés

Eligibility Liver Metastases NCT01763450

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written inform consent form
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
2. histologically or cytologically confirmed colorectal adenocarcinoma
Descripción

Adenocarcinoma of large intestine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1319315
3. age≥18 and ≤80 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
4. primary colorectal cancer and liver metastases，liver lesions determined to be unresectable by multidisciplinary team (mdt) （primary lesions surgically removed）
Descripción

Colorectal Carcinoma Primary | Secondary malignant neoplasm of liver | Lesion of liver Unresectable | Primary Lesion Excision

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C0494165
UMLS CUI [3,1]
C0577053
UMLS CUI [3,2]
C1519810
UMLS CUI [4,1]
C1402294
UMLS CUI [4,2]
C0728940
5. simultaneity or heterochrony metastases
Descripción

Neoplasm Metastasis Simultaneous | Neoplasm Metastasis | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0521115
UMLS CUI [2]
C0027627
UMLS CUI [3]
C3846158
6. colorectal cancer lesions from anal edge at least 8 cm
Descripción

Colorectal Carcinoma Lesion Location

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1515974
7. within 6 months did not receive any chemotherapy, including targeted therapy
Descripción

Chemotherapy Absent | Targeted Therapy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C0332197
8. one or more measurable lesions, conventional computed tomography(ct) scanning measurement diameter at least 20 mm [response evaluation criteria in solid tumors(recist) standard]
Descripción

Measurable lesion Quantity CT scan | Lesion Diameter

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1301886
9. eastern collaborative oncology group(ecog) 0 or 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
10. expected lifetime at least for 12 weeks
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
11. screening within 7 days， the ability of bone marrow, liver and kidney function reserve enough；absolute neutrophil count（anc）≥1.5x109/l; hemoglobin≥9.0g/dl; platelet count≥80 x109/l; total bilirubin(tbil)≤1.5 x upper level of normal range(uln); alanine aminotransferase(alt) and aspartate aminotransferase(ast)≤2.5 x uln(patients with hepatic metastasis≤5x uln); alkaline phosphatase≤4 x uln; serum creatinine≤1.5 x uln;
Descripción

Bone Marrow function Total | Liver function Total | Renal function Total | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Alkaline phosphatase measurement | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0439810
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0439810
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0439810
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0518015
UMLS CUI [6]
C0032181
UMLS CUI [7]
C1278039
UMLS CUI [8]
C0201836
UMLS CUI [9]
C0201899
UMLS CUI [10]
C0494165
UMLS CUI [11]
C0201850
UMLS CUI [12]
C0201976
12. women of reproductive age should take effective contraceptive measures;
Descripción

Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. arrhythmia requiring medication（except β- receptor blocking pharmacon and digoxigenin），symptomatic coronary artery disease and myocardial ischemia [myocardial infarction (≤6months before enrollment)]，congestive heart failure [≥new york heart association(nyha)2];
Descripción

Cardiac Arrhythmia Requirement Pharmaceutical Preparations | Exception Adrenergic beta-1 Receptor Antagonists | Exception Digoxigenin | Coronary Artery Disease Symptomatic | Myocardial Ischemia | Myocardial Infarction | Congestive heart failure New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0304516
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012264
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0231220
UMLS CUI [5]
C0151744
UMLS CUI [6]
C0027051
UMLS CUI [7,1]
C0018802
UMLS CUI [7,2]
C1275491
2. history of hiv infection,chronic hepatitis b or hepatitis c of active phase(high copy virus dna);
Descripción

HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
3. other activated serious infection [>national cancer institute-common toxicity criteria(nci-ctc) 3.0];
Descripción

Communicable Disease Serious CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1516728
4. any extrahepatic metastases;
Descripción

Neoplasm Metastasis Extrahepatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
5. seizures requiring medication(such as steroids or antiepileptic therapy);
Descripción

Seizures Requirement Pharmaceutical Preparations | Steroids | Antiepileptic Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
UMLS CUI [2]
C0038317
UMLS CUI [3]
C0003299
6. other malignancies in the past 5 years (except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix);
Descripción

Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
7. chronic inflammatory bowel disease, intestinal obstruction;
Descripción

Chronic inflammatory bowel disease | Intestinal Obstruction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1856359
UMLS CUI [2]
C0021843
8. drug abuse and medicine, psychology or social conditions may interfere with patients to participate in research or the results of the evaluation have influence;
Descripción

Drug abuse Interferes with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Condition Interferes with Study Subject Participation Status | Drug abuse Influence Evaluation Research results | Medical condition Influence Evaluation Research results | Mental condition Influence Evaluation Research results | Social Conditions Influence Evaluation Research results

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013146
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0037403
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C0013146
UMLS CUI [5,2]
C4054723
UMLS CUI [5,3]
C1261322
UMLS CUI [5,4]
C0683954
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C4054723
UMLS CUI [6,3]
C1261322
UMLS CUI [6,4]
C0683954
UMLS CUI [7,1]
C3840291
UMLS CUI [7,2]
C4054723
UMLS CUI [7,3]
C1261322
UMLS CUI [7,4]
C0683954
UMLS CUI [8,1]
C0037403
UMLS CUI [8,2]
C4054723
UMLS CUI [8,3]
C1261322
UMLS CUI [8,4]
C0683954
9. known or suspected allergy to any investigational drug in this study;
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
10. any unstable condition or is likely to endanger the patient safety and compliance situation;
Descripción

Patient's condition unstable | Condition At risk Patient safety | Condition At risk Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438114
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C1321605
11. pregnant or lactating women not using or refusing to use effective non hormonal means of contraception;
Descripción

Pregnancy | Breast Feeding | Contraceptive methods Absent | Contraceptive methods Refused | Contraceptive methods Except Hormonal Contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C1705116
UMLS CUI [5,1]
C0700589
UMLS CUI [5,2]
C0332300
UMLS CUI [5,3]
C2985296
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Similar models

Eligibility Liver Metastases NCT01763450

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written inform consent form
boolean
C0021430 (UMLS CUI [1])
Adenocarcinoma of large intestine
Item
2. histologically or cytologically confirmed colorectal adenocarcinoma
boolean
C1319315 (UMLS CUI [1])
Age
Item
3. age≥18 and ≤80 years old
boolean
C0001779 (UMLS CUI [1])
Colorectal Carcinoma Primary | Secondary malignant neoplasm of liver | Lesion of liver Unresectable | Primary Lesion Excision
Item
4. primary colorectal cancer and liver metastases，liver lesions determined to be unresectable by multidisciplinary team (mdt) （primary lesions surgically removed）
boolean
C0009402 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0494165 (UMLS CUI [2])
C0577053 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C1402294 (UMLS CUI [4,1])
C0728940 (UMLS CUI [4,2])
Neoplasm Metastasis Simultaneous | Neoplasm Metastasis | Other Coding
Item
5. simultaneity or heterochrony metastases
boolean
C0027627 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Colorectal Carcinoma Lesion Location
Item
6. colorectal cancer lesions from anal edge at least 8 cm
boolean
C0009402 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Chemotherapy Absent | Targeted Therapy Absent
Item
7. within 6 months did not receive any chemotherapy, including targeted therapy
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Measurable lesion Quantity CT scan | Lesion Diameter
Item
8. one or more measurable lesions, conventional computed tomography(ct) scanning measurement diameter at least 20 mm [response evaluation criteria in solid tumors(recist) standard]
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
ECOG performance status
Item
9. eastern collaborative oncology group(ecog) 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
10. expected lifetime at least for 12 weeks
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function Total | Liver function Total | Renal function Total | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Alkaline phosphatase measurement | Creatinine measurement, serum
Item
11. screening within 7 days， the ability of bone marrow, liver and kidney function reserve enough；absolute neutrophil count（anc）≥1.5x109/l; hemoglobin≥9.0g/dl; platelet count≥80 x109/l; total bilirubin(tbil)≤1.5 x upper level of normal range(uln); alanine aminotransferase(alt) and aspartate aminotransferase(ast)≤2.5 x uln(patients with hepatic metastasis≤5x uln); alkaline phosphatase≤4 x uln; serum creatinine≤1.5 x uln;
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0439810 (UMLS CUI [3,2])
C0948762 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0201899 (UMLS CUI [9])
C0494165 (UMLS CUI [10])
C0201850 (UMLS CUI [11])
C0201976 (UMLS CUI [12])
Childbearing Potential Contraceptive methods
Item
12. women of reproductive age should take effective contraceptive measures;
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Cardiac Arrhythmia Requirement Pharmaceutical Preparations | Exception Adrenergic beta-1 Receptor Antagonists | Exception Digoxigenin | Coronary Artery Disease Symptomatic | Myocardial Ischemia | Myocardial Infarction | Congestive heart failure New York Heart Association Classification
Item
1. arrhythmia requiring medication（except β- receptor blocking pharmacon and digoxigenin），symptomatic coronary artery disease and myocardial ischemia [myocardial infarction (≤6months before enrollment)]，congestive heart failure [≥new york heart association(nyha)2];
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0304516 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012264 (UMLS CUI [3,2])
C1956346 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0151744 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0018802 (UMLS CUI [7,1])
C1275491 (UMLS CUI [7,2])
HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
2. history of hiv infection,chronic hepatitis b or hepatitis c of active phase(high copy virus dna);
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
Communicable Disease Serious CTCAE Grades
Item
3. other activated serious infection [>national cancer institute-common toxicity criteria(nci-ctc) 3.0];
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Neoplasm Metastasis Extrahepatic
Item
4. any extrahepatic metastases;
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Seizures Requirement Pharmaceutical Preparations | Steroids | Antiepileptic Agents
Item
5. seizures requiring medication(such as steroids or antiepileptic therapy);
boolean
C0036572 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2])
C0003299 (UMLS CUI [3])
Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
6. other malignancies in the past 5 years (except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix);
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
Chronic inflammatory bowel disease | Intestinal Obstruction
Item
7. chronic inflammatory bowel disease, intestinal obstruction;
boolean
C1856359 (UMLS CUI [1])
C0021843 (UMLS CUI [2])
Drug abuse Interferes with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Condition Interferes with Study Subject Participation Status | Drug abuse Influence Evaluation Research results | Medical condition Influence Evaluation Research results | Mental condition Influence Evaluation Research results | Social Conditions Influence Evaluation Research results
Item
8. drug abuse and medicine, psychology or social conditions may interfere with patients to participate in research or the results of the evaluation have influence;
boolean
C0013146 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0037403 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0013146 (UMLS CUI [5,1])
C4054723 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C4054723 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C3840291 (UMLS CUI [7,1])
C4054723 (UMLS CUI [7,2])
C1261322 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C0037403 (UMLS CUI [8,1])
C4054723 (UMLS CUI [8,2])
C1261322 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs
Item
9. known or suspected allergy to any investigational drug in this study;
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Patient's condition unstable | Condition At risk Patient safety | Condition At risk Compliance
Item
10. any unstable condition or is likely to endanger the patient safety and compliance situation;
boolean
C0438114 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
Pregnancy | Breast Feeding | Contraceptive methods Absent | Contraceptive methods Refused | Contraceptive methods Except Hormonal Contraception
Item
11. pregnant or lactating women not using or refusing to use effective non hormonal means of contraception;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C1705116 (UMLS CUI [4,2])
C0700589 (UMLS CUI [5,1])
C0332300 (UMLS CUI [5,2])
C2985296 (UMLS CUI [5,3])
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