ID

44292

Description

NGR-hTNF in Combination With Standard Chemotherapy to Treat Patients With Advanced Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00994097

Link

https://clinicaltrials.gov/show/NCT00994097

Keywords

  1. 7/26/18 7/26/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Non-small Cell Lung Cancer NCT00994097

Eligibility Non-small Cell Lung Cancer NCT00994097

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically documented inoperable, locally advanced (stage iiib with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage iv) or recurrent nsclc. mixed tumors should be categorized according to the predominant cell type.
Description

Non-Small Cell Lung Carcinoma Inoperable | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Secondary malignant neoplasm of lymph node Supraclavicular | Pleural Effusion, Malignant | Malignant pericardial effusion | Non-small cell lung cancer metastatic TNM clinical staging | Non-small cell lung cancer recurrent | Mixed Neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205187
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [2,4]
C3258246
UMLS CUI [3,1]
C0686619
UMLS CUI [3,2]
C1550301
UMLS CUI [4]
C0080032
UMLS CUI [5]
C0220655
UMLS CUI [6,1]
C0278987
UMLS CUI [6,2]
C3258246
UMLS CUI [7]
C0278517
UMLS CUI [8]
C1368354
2. age ≥18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. life expectancy more than 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
4. ecog performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. at least one unidimensional measurable lesion (as per recist criteria)
Description

Measurable lesion Linear Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
6. adequate baseline bone marrow, hepatic and renal function, defined as follows:
Description

Bone Marrow function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
neutrophils >1.5 x 10^9/l and platelets > 100 x 10^9/l
Description

Neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
bilirubin <1.5 x uln
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
ast and/or alt <2.5 x uln in absence of liver metastasis
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0332197
ast and/or alt <5 x uln in presence of liver metastasis
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Present

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0150312
serum creatinine <1.5 x uln
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
creatinine clearance (estimated according to cockcroft-gault formula) ≥ 50 ml/min
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
7. patients may have had prior therapy providing the following conditions are met:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
radiation therapy: wash-out period of 28 days
Description

Therapeutic radiology procedure | Washout Period

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C1710661
surgery: wash-out period of 14 days
Description

Operative Surgical Procedures | Washout Period

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C1710661
8. patients must give written informed consent to participate in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor).
Description

Prior Chemotherapy | Antineoplastic Agents Systemic | Monoclonal antibodies, antineoplastic | Tyrosine kinase inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C3542957
UMLS CUI [4]
C1268567
2. patients must not receive any other investigational agents while on study
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
3. patients with myocardial infarction within the last six (6) months, unstable angina, new york heart association (nyha) grade ii or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
Description

Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C1514873
UMLS CUI [4,4]
C0013227
4. uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
5. prolonged qtc interval (congenital or acquired)
Description

Prolonged QTc interval Congenital | Prolonged QTc interval Acquired

Data type

boolean

Alias
UMLS CUI [1,1]
C1560305
UMLS CUI [1,2]
C1744681
UMLS CUI [2,1]
C1560305
UMLS CUI [2,2]
C0439661
6. patient with significant peripheral vascular disease
Description

Peripheral Vascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0085096
7. history or evidence upon physical examination of cns disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke).
Description

CNS disorder Physical Examination | Exception CNS disorder Treated | Brain Tumor, Primary | Metastatic malignant neoplasm to brain | Standard therapy Absent Seizure | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007682
UMLS CUI [2,3]
C1522326
UMLS CUI [3]
C0750974
UMLS CUI [4]
C0220650
UMLS CUI [5,1]
C2936643
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0036572
UMLS CUI [6]
C0038454
8. patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
Description

Systemic disease | Sepsis | Systemic disease Uncontrolled | Sepsis Uncontrolled | Illness Serious Inconsistent Study Protocol | Medical condition Serious Inconsistent Study Protocol

Data type

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2]
C0243026
UMLS CUI [3,1]
C0442893
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0243026
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0221423
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C0442809
UMLS CUI [5,4]
C2348563
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0205404
UMLS CUI [6,3]
C0442809
UMLS CUI [6,4]
C2348563
9. known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
Description

Allergic Reaction Albumin Human | Hypersensitivity Albumin Human | Medical contraindication Albumin Human | Allergic Reaction Albumin Human Excipient | Hypersensitivity Albumin Human Excipient | Medical contraindication Albumin Human Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0304925
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0304925
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0304925
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0304925
UMLS CUI [4,3]
C0015237
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0304925
UMLS CUI [5,3]
C0015237
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0304925
UMLS CUI [6,3]
C0015237
10. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
Description

Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
11. pregnancy or lactation. patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
Description

Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods | Menopausal Status Duration | Female Sterilization Absent | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C3829127
UMLS CUI [4,2]
C0449238
UMLS CUI [5,1]
C0015787
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0430061
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0430057

Similar models

Eligibility Non-small Cell Lung Cancer NCT00994097

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Inoperable | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Secondary malignant neoplasm of lymph node Supraclavicular | Pleural Effusion, Malignant | Malignant pericardial effusion | Non-small cell lung cancer metastatic TNM clinical staging | Non-small cell lung cancer recurrent | Mixed Neoplasm
Item
1. histologically or cytologically documented inoperable, locally advanced (stage iiib with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage iv) or recurrent nsclc. mixed tumors should be categorized according to the predominant cell type.
boolean
C0007131 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C0686619 (UMLS CUI [3,1])
C1550301 (UMLS CUI [3,2])
C0080032 (UMLS CUI [4])
C0220655 (UMLS CUI [5])
C0278987 (UMLS CUI [6,1])
C3258246 (UMLS CUI [6,2])
C0278517 (UMLS CUI [7])
C1368354 (UMLS CUI [8])
Age
Item
2. age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
3. life expectancy more than 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Measurable lesion Linear Quantity
Item
5. at least one unidimensional measurable lesion (as per recist criteria)
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Bone Marrow function | Liver function | Renal function
Item
6. adequate baseline bone marrow, hepatic and renal function, defined as follows:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Neutrophil count | Platelet Count measurement
Item
neutrophils >1.5 x 10^9/l and platelets > 100 x 10^9/l
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin <1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent
Item
ast and/or alt <2.5 x uln in absence of liver metastasis
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Present
Item
ast and/or alt <5 x uln in presence of liver metastasis
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
Creatinine measurement, serum
Item
serum creatinine <1.5 x uln
boolean
C0201976 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance (estimated according to cockcroft-gault formula) ≥ 50 ml/min
boolean
C2711451 (UMLS CUI [1])
Prior Therapy
Item
7. patients may have had prior therapy providing the following conditions are met:
boolean
C1514463 (UMLS CUI [1])
Therapeutic radiology procedure | Washout Period
Item
radiation therapy: wash-out period of 28 days
boolean
C1522449 (UMLS CUI [1])
C1710661 (UMLS CUI [2])
Operative Surgical Procedures | Washout Period
Item
surgery: wash-out period of 14 days
boolean
C0543467 (UMLS CUI [1])
C1710661 (UMLS CUI [2])
Informed Consent
Item
8. patients must give written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy | Antineoplastic Agents Systemic | Monoclonal antibodies, antineoplastic | Tyrosine kinase inhibitor
Item
1. prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor).
boolean
C1514457 (UMLS CUI [1])
C0003392 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C3542957 (UMLS CUI [3])
C1268567 (UMLS CUI [4])
Investigational New Drugs
Item
2. patients must not receive any other investigational agents while on study
boolean
C0013230 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations
Item
3. patients with myocardial infarction within the last six (6) months, unstable angina, new york heart association (nyha) grade ii or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C1514873 (UMLS CUI [4,3])
C0013227 (UMLS CUI [4,4])
Uncontrolled hypertension
Item
4. uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Prolonged QTc interval Congenital | Prolonged QTc interval Acquired
Item
5. prolonged qtc interval (congenital or acquired)
boolean
C1560305 (UMLS CUI [1,1])
C1744681 (UMLS CUI [1,2])
C1560305 (UMLS CUI [2,1])
C0439661 (UMLS CUI [2,2])
Peripheral Vascular Disease
Item
6. patient with significant peripheral vascular disease
boolean
C0085096 (UMLS CUI [1])
CNS disorder Physical Examination | Exception CNS disorder Treated | Brain Tumor, Primary | Metastatic malignant neoplasm to brain | Standard therapy Absent Seizure | Cerebrovascular accident
Item
7. history or evidence upon physical examination of cns disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke).
boolean
C0007682 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007682 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0750974 (UMLS CUI [3])
C0220650 (UMLS CUI [4])
C2936643 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0036572 (UMLS CUI [5,3])
C0038454 (UMLS CUI [6])
Systemic disease | Sepsis | Systemic disease Uncontrolled | Sepsis Uncontrolled | Illness Serious Inconsistent Study Protocol | Medical condition Serious Inconsistent Study Protocol
Item
8. patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
boolean
C0442893 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
C0442893 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0243026 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0221423 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0442809 (UMLS CUI [5,3])
C2348563 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0442809 (UMLS CUI [6,3])
C2348563 (UMLS CUI [6,4])
Allergic Reaction Albumin Human | Hypersensitivity Albumin Human | Medical contraindication Albumin Human | Allergic Reaction Albumin Human Excipient | Hypersensitivity Albumin Human Excipient | Medical contraindication Albumin Human Excipient
Item
9. known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
boolean
C1527304 (UMLS CUI [1,1])
C0304925 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304925 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0304925 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0304925 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0304925 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C1301624 (UMLS CUI [6,1])
C0304925 (UMLS CUI [6,2])
C0015237 (UMLS CUI [6,3])
Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance
Item
10. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods | Menopausal Status Duration | Female Sterilization Absent | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
11. pregnancy or lactation. patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3829127 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
C0015787 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0430061 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430057 (UMLS CUI [7,2])

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