0 Evaluaciones
ID

36405

Descripción

Efficacy and Safety of Bevacizumab Plus Sorafenib for the Third-line Treatment in Metastatic Renal Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02330783

Link

https://clinicaltrials.gov/show/NCT02330783

Palabras clave

Versiones (1)
  1. 11/05/19 11/05/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 maggio 2019

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Metastatic Renal Cell Carcinoma NCT02330783

    Inglés

    Eligibility Metastatic Renal Cell Carcinoma NCT02330783

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age≥18 years, ≤75 years, male or female
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    advanced renal cellcarcinoma is diagnosed histologically or pathologically
    Descripción

    Renal Cell Carcinoma Advanced

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0007134
    UMLS CUI [1,2]
    C0205179
    1st line treatment of sunitinib and 2nd line treatment of everolimus and no more systemic anti-angiogenesis targeted drug therapy
    Descripción

    First line treatment Sunitinib | Second line treatment Everolimus | Antiangiogenesis therapy Systemic

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1708063
    UMLS CUI [1,2]
    C1176020
    UMLS CUI [2,1]
    C1710038
    UMLS CUI [2,2]
    C0541315
    UMLS CUI [3,1]
    C0281318
    UMLS CUI [3,2]
    C0205373
    have at least one measurable tumor lesion (response evaluation criteria in solid tumors)
    Descripción

    Measurable lesion Quantity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1265611
    eastern cooperative oncology group（ecog) performance scale is 0 or 1
    Descripción

    ECOG performance status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    the expected life span is ≥12 weeks
    Descripción

    Life Expectancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    no contraindications for chemotherapy, with enough liver function and renal function and normal ecg recording peripheral hemogram: neutrophil≥1.5×109/l, plt≥100×109/l, hgb≥90g/l renal function: serum creatinine≤1.5 folds the upper limit of normal (uln) for patients with non-metastatic liver dysfunction:alanine aminotransferase and aspartate aminotransferase≤2.5 uln, for patients with metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 uln
    Descripción

    Medical contraindication Absent Chemotherapy | Liver function | Renal function | Hematologic function | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Creatinine measurement, serum | Liver Dysfunction Without Neoplasm Metastasis | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Dysfunction metastatic

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [1,3]
    C0392920
    UMLS CUI [2]
    C0232741
    UMLS CUI [3]
    C0232804
    UMLS CUI [4]
    C0221130
    UMLS CUI [5]
    C0200633
    UMLS CUI [6]
    C0032181
    UMLS CUI [7]
    C0518015
    UMLS CUI [8]
    C0201976
    UMLS CUI [9,1]
    C0086565
    UMLS CUI [9,2]
    C0332288
    UMLS CUI [9,3]
    C0027627
    UMLS CUI [10]
    C0201836
    UMLS CUI [11]
    C0201899
    UMLS CUI [12,1]
    C0086565
    UMLS CUI [12,2]
    C1522484
    the patients participate voluntarily and have signed the informed consent form
    Descripción

    Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures
    Descripción

    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C0332197
    patients with severe acute infection without being controlled effectively or having pyogenic and chronic infections with persistently unhealed wounds
    Descripción

    Communicable Disease Severe Poorly controlled | Infection pyogenic | Chronic infectious disease | Non-healed wound Persistent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C3853134
    UMLS CUI [2]
    C0858906
    UMLS CUI [3]
    C0151317
    UMLS CUI [4,1]
    C0750433
    UMLS CUI [4,2]
    C0205322
    past history of serious heart diseases, including: cardiac function classification ≥nyha class ii, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension
    Descripción

    Heart Disease Serious | Cardiac function New York Heart Association Classification | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists | Exception Digoxin | Uncontrolled hypertension

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [2,1]
    C0232164
    UMLS CUI [2,2]
    C1275491
    UMLS CUI [3]
    C0002965
    UMLS CUI [4]
    C0027051
    UMLS CUI [5,1]
    C0003811
    UMLS CUI [5,2]
    C1514873
    UMLS CUI [5,3]
    C0003195
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C0304516
    UMLS CUI [7,1]
    C1705847
    UMLS CUI [7,2]
    C0012265
    UMLS CUI [8]
    C1868885
    patients with a history of hiv infection or active phase of chronic hepatitis b/c
    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
    negative imaging examination result 4 weeks prior to enrollment)
    Descripción

    Imaging Negative

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1513916
    epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs)
    Descripción

    Epilepsy Requirement Pharmacotherapy | Steroids | Antiepileptic Agents

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0014544
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0013216
    UMLS CUI [2]
    C0038317
    UMLS CUI [3]
    C0003299
    a history of allogeneic organ transplantation
    Descripción

    Organ Transplantation Allogeneic

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0029216
    UMLS CUI [1,2]
    C1515895
    patients with evidence of hemorrhagic constitution or a past history of hemorrhage
    Descripción

    Patient constitution Hemorrhagic | Hemorrhage In the past

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0683521
    UMLS CUI [1,2]
    C0333275
    UMLS CUI [2,1]
    C0019080
    UMLS CUI [2,2]
    C1444637
    patients currently receiving renal dialysis
    Descripción

    Dialysis renal

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0011946
    UMLS CUI [1,2]
    C0022646
    past or present concomitant tumors with the primary lesions or histological characteristics different from the tumors evaluated in this study, excluding other tumor cured longer than 3 years before enrollment
    Descripción

    Cancer Other | Exception Neoplasm Cured

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1707251
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0027651
    UMLS CUI [2,3]
    C1880198
    patients participating in other clinical trials simultaneously
    Descripción

    Study Subject Participation Status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    other conditions unsatisfying the inclusion criteria in the investigator's opinions
    Descripción

    Condition Inconsistent Inclusion criteria

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C0442809
    UMLS CUI [1,3]
    C1512693
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    Similar models

    Eligibility Metastatic Renal Cell Carcinoma NCT02330783

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age≥18 years, ≤75 years, male or female
    boolean
    C0001779 (UMLS CUI [1])
    Renal Cell Carcinoma Advanced
    Item
    advanced renal cellcarcinoma is diagnosed histologically or pathologically
    boolean
    C0007134 (UMLS CUI [1,1])
    C0205179 (UMLS CUI [1,2])
    First line treatment Sunitinib | Second line treatment Everolimus | Antiangiogenesis therapy Systemic
    Item
    1st line treatment of sunitinib and 2nd line treatment of everolimus and no more systemic anti-angiogenesis targeted drug therapy
    boolean
    C1708063 (UMLS CUI [1,1])
    C1176020 (UMLS CUI [1,2])
    C1710038 (UMLS CUI [2,1])
    C0541315 (UMLS CUI [2,2])
    C0281318 (UMLS CUI [3,1])
    C0205373 (UMLS CUI [3,2])
    Measurable lesion Quantity
    Item
    have at least one measurable tumor lesion (response evaluation criteria in solid tumors)
    boolean
    C1513041 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    ECOG performance status
    Item
    eastern cooperative oncology group（ecog) performance scale is 0 or 1
    boolean
    C1520224 (UMLS CUI [1])
    Life Expectancy
    Item
    the expected life span is ≥12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    Medical contraindication Absent Chemotherapy | Liver function | Renal function | Hematologic function | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Creatinine measurement, serum | Liver Dysfunction Without Neoplasm Metastasis | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Dysfunction metastatic
    Item
    no contraindications for chemotherapy, with enough liver function and renal function and normal ecg recording peripheral hemogram: neutrophil≥1.5×109/l, plt≥100×109/l, hgb≥90g/l renal function: serum creatinine≤1.5 folds the upper limit of normal (uln) for patients with non-metastatic liver dysfunction:alanine aminotransferase and aspartate aminotransferase≤2.5 uln, for patients with metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 uln
    boolean
    C1301624 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0392920 (UMLS CUI [1,3])
    C0232741 (UMLS CUI [2])
    C0232804 (UMLS CUI [3])
    C0221130 (UMLS CUI [4])
    C0200633 (UMLS CUI [5])
    C0032181 (UMLS CUI [6])
    C0518015 (UMLS CUI [7])
    C0201976 (UMLS CUI [8])
    C0086565 (UMLS CUI [9,1])
    C0332288 (UMLS CUI [9,2])
    C0027627 (UMLS CUI [9,3])
    C0201836 (UMLS CUI [10])
    C0201899 (UMLS CUI [11])
    C0086565 (UMLS CUI [12,1])
    C1522484 (UMLS CUI [12,2])
    Informed Consent
    Item
    the patients participate voluntarily and have signed the informed consent form
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
    Item
    pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C0332197 (UMLS CUI [3,3])
    Communicable Disease Severe Poorly controlled | Infection pyogenic | Chronic infectious disease | Non-healed wound Persistent
    Item
    patients with severe acute infection without being controlled effectively or having pyogenic and chronic infections with persistently unhealed wounds
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C3853134 (UMLS CUI [1,3])
    C0858906 (UMLS CUI [2])
    C0151317 (UMLS CUI [3])
    C0750433 (UMLS CUI [4,1])
    C0205322 (UMLS CUI [4,2])
    Heart Disease Serious | Cardiac function New York Heart Association Classification | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists | Exception Digoxin | Uncontrolled hypertension
    Item
    past history of serious heart diseases, including: cardiac function classification ≥nyha class ii, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension
    boolean
    C0018799 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0232164 (UMLS CUI [2,1])
    C1275491 (UMLS CUI [2,2])
    C0002965 (UMLS CUI [3])
    C0027051 (UMLS CUI [4])
    C0003811 (UMLS CUI [5,1])
    C1514873 (UMLS CUI [5,2])
    C0003195 (UMLS CUI [5,3])
    C1705847 (UMLS CUI [6,1])
    C0304516 (UMLS CUI [6,2])
    C1705847 (UMLS CUI [7,1])
    C0012265 (UMLS CUI [7,2])
    C1868885 (UMLS CUI [8])
    HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic
    Item
    patients with a history of hiv infection or active phase of chronic hepatitis b/c
    boolean
    C0019693 (UMLS CUI [1])
    C0524909 (UMLS CUI [2])
    C0524910 (UMLS CUI [3])
    Imaging Negative
    Item
    negative imaging examination result 4 weeks prior to enrollment)
    boolean
    C0011923 (UMLS CUI [1,1])
    C1513916 (UMLS CUI [1,2])
    Epilepsy Requirement Pharmacotherapy | Steroids | Antiepileptic Agents
    Item
    epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs)
    boolean
    C0014544 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0013216 (UMLS CUI [1,3])
    C0038317 (UMLS CUI [2])
    C0003299 (UMLS CUI [3])
    Organ Transplantation Allogeneic
    Item
    a history of allogeneic organ transplantation
    boolean
    C0029216 (UMLS CUI [1,1])
    C1515895 (UMLS CUI [1,2])
    Patient constitution Hemorrhagic | Hemorrhage In the past
    Item
    patients with evidence of hemorrhagic constitution or a past history of hemorrhage
    boolean
    C0683521 (UMLS CUI [1,1])
    C0333275 (UMLS CUI [1,2])
    C0019080 (UMLS CUI [2,1])
    C1444637 (UMLS CUI [2,2])
    Dialysis renal
    Item
    patients currently receiving renal dialysis
    boolean
    C0011946 (UMLS CUI [1,1])
    C0022646 (UMLS CUI [1,2])
    Cancer Other | Exception Neoplasm Cured
    Item
    past or present concomitant tumors with the primary lesions or histological characteristics different from the tumors evaluated in this study, excluding other tumor cured longer than 3 years before enrollment
    boolean
    C1707251 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0027651 (UMLS CUI [2,2])
    C1880198 (UMLS CUI [2,3])
    Study Subject Participation Status
    Item
    patients participating in other clinical trials simultaneously
    boolean
    C2348568 (UMLS CUI [1])
    Condition Inconsistent Inclusion criteria
    Item
    other conditions unsatisfying the inclusion criteria in the investigator's opinions
    boolean
    C0348080 (UMLS CUI [1,1])
    C0442809 (UMLS CUI [1,2])
    C1512693 (UMLS CUI [1,3])
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