ID

36406

Description

A Phase II Trila of Sunitinib Schedule 4/2 vs. Shedule 2/1 as First Line Therapy in Metastatic Renal Cell Carcinoma.; ODM derived from: https://clinicaltrials.gov/show/NCT02398552

Link

https://clinicaltrials.gov/show/NCT02398552

Keywords

Versions (1)
  1. 5/11/19 5/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Renal Cell Carcinoma NCT02398552

English

Eligibility Metastatic Renal Cell Carcinoma NCT02398552

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
advanced renal cell carcinoma is diagnosed histologically or pathologically
Description

Renal Cell Carcinoma Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C0007134
UMLS CUI [1,2]
C0205179
treatment naive at diagnosed
Description

Therapy naive

Data type

boolean

Alias
UMLS CUI [1]
C0919936
at least one measurable tumor lesion (response evaluation criteria in solid tumors)
Description

Measurable lesion Quantity

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
no contraindications for targeted therapy, 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
Description

Medical contraindication Absent Targeted Therapy | 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

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C2985566
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
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have received any systemic therapy including targeted therapy,immunotherapy,chemotherapy etc at diagnosed.
Description

Systemic therapy | Targeted Therapy | Immunotherapy | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1515119
UMLS CUI [2]
C2985566
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0392920
pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

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
Description

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

Data type

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
Description

Heart Diseases Serious | Cardiac function New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0232164
UMLS CUI [2,2]
C1275491
≥nyha class ii, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension
Description

Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists | Exception Digoxin | Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0003195
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0304516
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012265
UMLS CUI [6]
C1868885
patients with a history of hiv infection or active phase of chronic hepatitis b/c
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
negative imaging examination result 4 weeks prior to enrollment)
Description

Imaging Negative

Data type

boolean

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

Epilepsy Requirement Pharmacotherapy | Steroids | Antiepileptic Agents

Data type

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
Description

Organ Transplantation Allogeneic

Data type

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C1515895
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Similar models

Eligibility Metastatic Renal Cell Carcinoma NCT02398552

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 cell carcinoma is diagnosed histologically or pathologically
boolean
C0007134 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Therapy naive
Item
treatment naive at diagnosed
boolean
C0919936 (UMLS CUI [1])
Measurable lesion Quantity
Item
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 Targeted Therapy | 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 targeted therapy, 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])
C2985566 (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)
Systemic therapy | Targeted Therapy | Immunotherapy | Chemotherapy
Item
patients who have received any systemic therapy including targeted therapy,immunotherapy,chemotherapy etc at diagnosed.
boolean
C1515119 (UMLS CUI [1])
C2985566 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
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 Diseases Serious | Cardiac function New York Heart Association Classification
Item
past history of serious heart diseases, including: cardiac function classification
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0232164 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists | Exception Digoxin | Uncontrolled hypertension
Item
≥nyha class ii, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0003195 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0304516 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0012265 (UMLS CUI [5,2])
C1868885 (UMLS CUI [6])
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])
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