ID

31197

Beschrijving

Adjuvant Vinorelbine Plus Cisplatin(NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer(NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT01124253

Link

https://clinicaltrials.gov/show/NCT01124253

Trefwoorden

Versies (1)
  1. 27-07-18 27-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

27 juli 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT01124253

Engels

Eligibility Non-small Cell Lung Cancer NCT01124253

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed non-small cell lung cancer, the pathology type includes squamous cell carcinoma, adenocarcinoma, large-cell carcinoma, and any mixed type of the 3 types mentioned above.
Beschrijving

Non-Small Cell Lung Carcinoma | Squamous cell carcinoma | Adenocarcinoma | Carcinoma, Large Cell | Type Mixed

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0007137
UMLS CUI [3]
C0001418
UMLS CUI [4]
C0206704
UMLS CUI [5,1]
C0332307
UMLS CUI [5,2]
C0205430
stage ib-iiia non-small cell lung cancer, tumor was completely resected (the type of surgery including lobectomy, left side pneumonectomy,bi-lobectomy).
Beschrijving

Non-Small Cell Lung Carcinoma TNM clinical staging | Tumor Complete excision | Type Operative Surgical Procedures | Lobectomy | LUNG LEFT PNEUMONECTOMY | Bilobectomy of lung

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0015250
UMLS CUI [3,1]
C0332307
UMLS CUI [3,2]
C0543467
UMLS CUI [4]
C0023928
UMLS CUI [5]
C0746125
UMLS CUI [6]
C0396580
the time from surgery to first dose of adjuvant chemotherapy are mandatory between 4-8 weeks.
Beschrijving

Timespan Operative Surgical Procedures Adjuvant Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0872291
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0085533
no evidence of tumor relapse prior to adjuvant therapy.
Beschrijving

Absence Recurrent tumor prior to Adjuvant therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0521158
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0677850
age 18-70, eastern cooperative oncology group(ecog) performance status 0-1.
Beschrijving

Age | ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
normal hematologic function.renal function , hepatic and cardiac function will be within the acceptable ranges as following:serum bilirubin, aspartate aminotransferase(ast)and alamine aminotransferase(alt)levels below 1.5 times of normal value.
Beschrijving

Hematologic function | Renal function | Liver function | Cardiac function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0232164
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
no history of chemotherapy or radiotherapy;
Beschrijving

Chemotherapy Absent | Therapeutic radiology procedure Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
the patient should have well compliance for chemotherapy and follow up
Beschrijving

Compliance behavior Chemotherapy | Compliance behavior Follow-up

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
informed consent should be obtained before treatment.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
the histological or cytological documents do not match the inclusion criteria.
Beschrijving

Documents Histologic Mismatch Inclusion criteria | Documents Cytologic Mismatch Inclusion criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301746
UMLS CUI [1,2]
C0205462
UMLS CUI [1,3]
C1881865
UMLS CUI [1,4]
C1512693
UMLS CUI [2,1]
C1301746
UMLS CUI [2,2]
C0205471
UMLS CUI [2,3]
C1881865
UMLS CUI [2,4]
C1512693
right side pneumonectomy or any kind of incompletely resected surgery.
Beschrijving

LUNG RIGHT PNEUMONECTOMY | Incomplete Resection

Datatype

boolean

Alias
UMLS CUI [1]
C0746225
UMLS CUI [2]
C4330937
the recruitment time are beyond 8 weeks from surgery.
Beschrijving

Timespan Patient Recruitment Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0872291
UMLS CUI [1,2]
C0242800
UMLS CUI [1,3]
C0543467
any concurrent acute or chronic systemic diseases or psychiatric diseases, which might both increase the risks of the research itself or the medical therapy and influence the research results analysis. the researchers can make a judge for the following conditions to tell whether they are fit for this research:uncontrolled high blood pressure, unstable angina , myocardial infarction , uncontrolled arrhythmia,or congestive heart failure with clinical symptoms within 12 weeks before randomization.evidence of anemia from electrocardiographic manifestation or heart valve disease with confirmed clinical diagnosis.clinically significant active infection state due to bacteria, virus and fungi invasion. patients with grade ii arrhythmia, grade ii myocardial anemia, grade ii abnormal cardiac troponin t, grade ii high blood pressure or left ventricle ejection fraction (lvef) less than 50 percent according to ctc 3.0 are not permitted to enrol the study.
Beschrijving

Systemic disease At risk Clinical Trial | Systemic disease chronic At risk Clinical Trial | Mental disorders At risk Clinical Trial | Systemic disease At risk Therapeutic procedure | Systemic disease chronic At risk Therapeutic procedure | Mental disorders At risk Therapeutic procedure | Systemic disease Influence Research results Analysis | Systemic disease chronic Influence Research results Analysis | Mental disorders Influence Research results Analysis | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled | Symptomatic congestive heart failure | Anemia Electrocardiography | Heart valve disease | Bacterial Infections | Virus Diseases | Mycoses | Cardiac Arrhythmia Grade | Anemia Myocardial Grade | Cardiac Troponin T Abnormal CTCAE Grades | Hypertensive disease Grade | Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C0008976
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0008976
UMLS CUI [4,1]
C0442893
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0087111
UMLS CUI [5,1]
C0442893
UMLS CUI [5,2]
C0205191
UMLS CUI [5,3]
C1444641
UMLS CUI [5,4]
C0087111
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C1444641
UMLS CUI [6,3]
C0087111
UMLS CUI [7,1]
C0442893
UMLS CUI [7,2]
C4054723
UMLS CUI [7,3]
C0683954
UMLS CUI [7,4]
C0936012
UMLS CUI [8,1]
C0442893
UMLS CUI [8,2]
C0205191
UMLS CUI [8,3]
C4054723
UMLS CUI [8,4]
C0683954
UMLS CUI [8,5]
C0936012
UMLS CUI [9,1]
C0004936
UMLS CUI [9,2]
C4054723
UMLS CUI [9,3]
C0683954
UMLS CUI [9,4]
C0936012
UMLS CUI [10]
C1868885
UMLS CUI [11]
C0002965
UMLS CUI [12]
C0027051
UMLS CUI [13,1]
C0003811
UMLS CUI [13,2]
C0205318
UMLS CUI [14]
C0742758
UMLS CUI [15,1]
C0002871
UMLS CUI [15,2]
C1623258
UMLS CUI [16]
C0018824
UMLS CUI [17]
C0004623
UMLS CUI [18]
C0042769
UMLS CUI [19]
C0026946
UMLS CUI [20,1]
C0003811
UMLS CUI [20,2]
C0441800
UMLS CUI [21,1]
C0002871
UMLS CUI [21,2]
C1522564
UMLS CUI [21,3]
C0441800
UMLS CUI [22,1]
C3538889
UMLS CUI [22,2]
C0205161
UMLS CUI [22,3]
C1516728
UMLS CUI [23,1]
C0020538
UMLS CUI [23,2]
C0441800
UMLS CUI [24]
C0428772
women with pregnant or lactation.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
before enter the group,the patients had other malignant tumors except for non-melanoma skin cancer, carcinoma in situ and cured early-stage prostate cancer.
Beschrijving

Cancer Other | Exception Skin carcinoma | Exception Carcinoma in Situ | Exception Prostate carcinoma Early stage Cured

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0600139
UMLS CUI [4,3]
C2363430
UMLS CUI [4,4]
C1880198
with allergic constitution or possible allergic reflection to any known research drugs.
Beschrijving

Hypersensitivity Investigational New Drugs | Allergic Reaction Possible Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0332149
UMLS CUI [2,3]
C0013230
poor compliance.
Beschrijving

Poor compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0032646
not proper for the research according to the researchers' judgment.
Beschrijving

Study Subject Participation Status Inappropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Non-small Cell Lung Cancer NCT01124253

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Squamous cell carcinoma | Adenocarcinoma | Carcinoma, Large Cell | Type Mixed
Item
histologically confirmed non-small cell lung cancer, the pathology type includes squamous cell carcinoma, adenocarcinoma, large-cell carcinoma, and any mixed type of the 3 types mentioned above.
boolean
C0007131 (UMLS CUI [1])
C0007137 (UMLS CUI [2])
C0001418 (UMLS CUI [3])
C0206704 (UMLS CUI [4])
C0332307 (UMLS CUI [5,1])
C0205430 (UMLS CUI [5,2])
Non-Small Cell Lung Carcinoma TNM clinical staging | Tumor Complete excision | Type Operative Surgical Procedures | Lobectomy | LUNG LEFT PNEUMONECTOMY | Bilobectomy of lung
Item
stage ib-iiia non-small cell lung cancer, tumor was completely resected (the type of surgery including lobectomy, left side pneumonectomy,bi-lobectomy).
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0015250 (UMLS CUI [2,2])
C0332307 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0023928 (UMLS CUI [4])
C0746125 (UMLS CUI [5])
C0396580 (UMLS CUI [6])
Timespan Operative Surgical Procedures Adjuvant Chemotherapy
Item
the time from surgery to first dose of adjuvant chemotherapy are mandatory between 4-8 weeks.
boolean
C0872291 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0085533 (UMLS CUI [1,3])
Absence Recurrent tumor prior to Adjuvant therapy
Item
no evidence of tumor relapse prior to adjuvant therapy.
boolean
C0332197 (UMLS CUI [1,1])
C0521158 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0677850 (UMLS CUI [1,4])
Age | ECOG performance status
Item
age 18-70, eastern cooperative oncology group(ecog) performance status 0-1.
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Hematologic function | Renal function | Liver function | Cardiac function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
normal hematologic function.renal function , hepatic and cardiac function will be within the acceptable ranges as following:serum bilirubin, aspartate aminotransferase(ast)and alamine aminotransferase(alt)levels below 1.5 times of normal value.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0232164 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
Chemotherapy Absent | Therapeutic radiology procedure Absent
Item
no history of chemotherapy or radiotherapy;
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Compliance behavior Chemotherapy | Compliance behavior Follow-up
Item
the patient should have well compliance for chemotherapy and follow up
boolean
C1321605 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
Informed Consent
Item
informed consent should be obtained before treatment.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Documents Histologic Mismatch Inclusion criteria | Documents Cytologic Mismatch Inclusion criteria
Item
the histological or cytological documents do not match the inclusion criteria.
boolean
C1301746 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C1881865 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,4])
C1301746 (UMLS CUI [2,1])
C0205471 (UMLS CUI [2,2])
C1881865 (UMLS CUI [2,3])
C1512693 (UMLS CUI [2,4])
LUNG RIGHT PNEUMONECTOMY | Incomplete Resection
Item
right side pneumonectomy or any kind of incompletely resected surgery.
boolean
C0746225 (UMLS CUI [1])
C4330937 (UMLS CUI [2])
Timespan Patient Recruitment Operative Surgical Procedures
Item
the recruitment time are beyond 8 weeks from surgery.
boolean
C0872291 (UMLS CUI [1,1])
C0242800 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Systemic disease At risk Clinical Trial | Systemic disease chronic At risk Clinical Trial | Mental disorders At risk Clinical Trial | Systemic disease At risk Therapeutic procedure | Systemic disease chronic At risk Therapeutic procedure | Mental disorders At risk Therapeutic procedure | Systemic disease Influence Research results Analysis | Systemic disease chronic Influence Research results Analysis | Mental disorders Influence Research results Analysis | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled | Symptomatic congestive heart failure | Anemia Electrocardiography | Heart valve disease | Bacterial Infections | Virus Diseases | Mycoses | Cardiac Arrhythmia Grade | Anemia Myocardial Grade | Cardiac Troponin T Abnormal CTCAE Grades | Hypertensive disease Grade | Left ventricular ejection fraction
Item
any concurrent acute or chronic systemic diseases or psychiatric diseases, which might both increase the risks of the research itself or the medical therapy and influence the research results analysis. the researchers can make a judge for the following conditions to tell whether they are fit for this research:uncontrolled high blood pressure, unstable angina , myocardial infarction , uncontrolled arrhythmia,or congestive heart failure with clinical symptoms within 12 weeks before randomization.evidence of anemia from electrocardiographic manifestation or heart valve disease with confirmed clinical diagnosis.clinically significant active infection state due to bacteria, virus and fungi invasion. patients with grade ii arrhythmia, grade ii myocardial anemia, grade ii abnormal cardiac troponin t, grade ii high blood pressure or left ventricle ejection fraction (lvef) less than 50 percent according to ctc 3.0 are not permitted to enrol the study.
boolean
C0442893 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
C0442893 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0442893 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0087111 (UMLS CUI [5,4])
C0004936 (UMLS CUI [6,1])
C1444641 (UMLS CUI [6,2])
C0087111 (UMLS CUI [6,3])
C0442893 (UMLS CUI [7,1])
C4054723 (UMLS CUI [7,2])
C0683954 (UMLS CUI [7,3])
C0936012 (UMLS CUI [7,4])
C0442893 (UMLS CUI [8,1])
C0205191 (UMLS CUI [8,2])
C4054723 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
C0936012 (UMLS CUI [8,5])
C0004936 (UMLS CUI [9,1])
C4054723 (UMLS CUI [9,2])
C0683954 (UMLS CUI [9,3])
C0936012 (UMLS CUI [9,4])
C1868885 (UMLS CUI [10])
C0002965 (UMLS CUI [11])
C0027051 (UMLS CUI [12])
C0003811 (UMLS CUI [13,1])
C0205318 (UMLS CUI [13,2])
C0742758 (UMLS CUI [14])
C0002871 (UMLS CUI [15,1])
C1623258 (UMLS CUI [15,2])
C0018824 (UMLS CUI [16])
C0004623 (UMLS CUI [17])
C0042769 (UMLS CUI [18])
C0026946 (UMLS CUI [19])
C0003811 (UMLS CUI [20,1])
C0441800 (UMLS CUI [20,2])
C0002871 (UMLS CUI [21,1])
C1522564 (UMLS CUI [21,2])
C0441800 (UMLS CUI [21,3])
C3538889 (UMLS CUI [22,1])
C0205161 (UMLS CUI [22,2])
C1516728 (UMLS CUI [22,3])
C0020538 (UMLS CUI [23,1])
C0441800 (UMLS CUI [23,2])
C0428772 (UMLS CUI [24])
Pregnancy | Breast Feeding
Item
women with pregnant or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Skin carcinoma | Exception Carcinoma in Situ | Exception Prostate carcinoma Early stage Cured
Item
before enter the group,the patients had other malignant tumors except for non-melanoma skin cancer, carcinoma in situ and cured early-stage prostate cancer.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C2363430 (UMLS CUI [4,3])
C1880198 (UMLS CUI [4,4])
Hypersensitivity Investigational New Drugs | Allergic Reaction Possible Investigational New Drugs
Item
with allergic constitution or possible allergic reflection to any known research drugs.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Poor compliance
Item
poor compliance.
boolean
C0032646 (UMLS CUI [1])
Study Subject Participation Status Inappropriate
Item
not proper for the research according to the researchers' judgment.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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