ID

38393

Description

Study of Gefitinib Retreatment in Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00824746

Link

https://clinicaltrials.gov/show/NCT00824746

Keywords

Versions (1)
  1. 10/15/19 10/15/19 -
Copyright Holder

See clinicaltrials.gov

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October 15, 2019

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00824746

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT00824746

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
recurrent or progressive non-small cell lung cancer (nsclc) stage iv or iiib patients after chemotherapy following gefitinib failure
Description

Non-small cell lung cancer recurrent TNM clinical staging | Non-Small Cell Lung Carcinoma Progressive TNM clinical staging | Chemotherapy | Status post Gefitinib failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0278517
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205329
UMLS CUI [2,3]
C3258246
UMLS CUI [3]
C0392920
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1122962
UMLS CUI [4,3]
C0231175
male and female patients aged over 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
world health organization (who) performance status 0-2 (those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
had at least stable disease with previous gefitinib treatment
Description

Stable Disease | Prior Therapy Gefitinib

Data type

boolean

Alias
UMLS CUI [1]
C0677946
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1122962
had at least one anticancer agent therapy after gefitinib failure ;following treatment with another epidermal growth factor receptor (egfr) tyrosine kinase inhibitors (tkis)- erlotinib or other tkis should not be included in anticancer agent therapy.
Description

Antineoplastic Agent Therapy Quantity | Status post Gefitinib failed | EGFR Tyrosine Kinase Inhibitors | Erlotinib Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C2346834
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1122962
UMLS CUI [2,3]
C0231175
UMLS CUI [3]
C1443775
UMLS CUI [4,1]
C1135135
UMLS CUI [4,2]
C0332196
the current approved indication of gefitinib is 2nd or 3rd line monotherapy for recurrent or metastatic nsclc. however, in practice with off-label indication, it can also be used as a 1st line treatment at the patient's own expenses. thus, in this trial gefitinib retreatment will be 3rd line or more.
Description

Indication Gefitinib | Second line treatment Non-small cell lung cancer recurrent | Third line treatment Non-small cell lung cancer recurrent | Second line treatment Non-small cell lung cancer metastatic | Third line treatment Non-small cell lung cancer metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1122962
UMLS CUI [2,1]
C1710038
UMLS CUI [2,2]
C0278517
UMLS CUI [3,1]
C2986605
UMLS CUI [3,2]
C0278517
UMLS CUI [4,1]
C1710038
UMLS CUI [4,2]
C0278987
UMLS CUI [5,1]
C2986605
UMLS CUI [5,2]
C0278987
measurable lesion according to response evaluation criteria in solid tumors(recist) with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
Description

Measurable lesion | Prior radiation therapy Absent Measurable lesion Quantity | Exception Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1513041
UMLS CUI [2,4]
C1265611
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0242656
provision of written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
life expectancy of at least 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
Description

Lung Diseases, Interstitial

Data type

boolean

Alias
UMLS CUI [1]
C0206062
expected life expectancy less than 2 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
known severe hypersensitivity to gefitinib or any of the excipients of this product
Description

Severe allergy Gefitinib | Severe allergy Gefitinib Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C1122962
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C1122962
UMLS CUI [2,3]
C0015237
any unresolved chronic toxicity greater that common terminology criteria (ctc) grade 2 from previous anticancer therapy
Description

Resolution Lacking | Toxicity chronic CTCAE Grades | Etiology Cancer treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1514893
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C1516728
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0920425
as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Description

Systemic disease Severe | Systemic disease Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Uncompensated | Heart Disease Uncompensated | Liver disease Uncompensated | Kidney Disease Uncompensated

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0035204
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0443343
UMLS CUI [7,1]
C0035204
UMLS CUI [7,2]
C0205433
UMLS CUI [8,1]
C0018799
UMLS CUI [8,2]
C0205433
UMLS CUI [9,1]
C0023895
UMLS CUI [9,2]
C0205433
UMLS CUI [10,1]
C0022658
UMLS CUI [10,2]
C0205433
serum bilirubin greater than 3 times the upper limit of reference range (ulrr)
Description

Serum bilirubin increased

Data type

boolean

Alias
UMLS CUI [1]
C0859062
aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt) ≥ 2.5 x upper limit normal (uln) if no demonstrable liver metastases (or >5 x in presence of liver metastases)
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0494165
UMLS CUI [4,2]
C0150312
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Description

Disease Clinical Significance Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C3640815
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C3640815
pregnancy or breast-feeding women (women of child¬bearing potential). women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
newly diagnosed central nervous system (cns) metastases that have not yet been treated with surgery and/or radiation. patients with previously diagnosed and treated cns metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (no steroid therapy or steroid dose being tapered) for at least 2 weeks
Description

Operative Surgical Procedures Absent CNS metastases | Therapeutic radiology procedure Absent CNS metastases

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0686377
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0686377
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00824746

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-small cell lung cancer recurrent TNM clinical staging | Non-Small Cell Lung Carcinoma Progressive TNM clinical staging | Chemotherapy | Status post Gefitinib failed
Item
recurrent or progressive non-small cell lung cancer (nsclc) stage iv or iiib patients after chemotherapy following gefitinib failure
boolean
C0278517 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C1122962 (UMLS CUI [4,2])
C0231175 (UMLS CUI [4,3])
Age
Item
male and female patients aged over 18 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
world health organization (who) performance status 0-2 (those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
boolean
C1298650 (UMLS CUI [1])
Stable Disease | Prior Therapy Gefitinib
Item
had at least stable disease with previous gefitinib treatment
boolean
C0677946 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C1122962 (UMLS CUI [2,2])
Antineoplastic Agent Therapy Quantity | Status post Gefitinib failed | EGFR Tyrosine Kinase Inhibitors | Erlotinib Excluded
Item
had at least one anticancer agent therapy after gefitinib failure ;following treatment with another epidermal growth factor receptor (egfr) tyrosine kinase inhibitors (tkis)- erlotinib or other tkis should not be included in anticancer agent therapy.
boolean
C2346834 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1122962 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C1443775 (UMLS CUI [3])
C1135135 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
Indication Gefitinib | Second line treatment Non-small cell lung cancer recurrent | Third line treatment Non-small cell lung cancer recurrent | Second line treatment Non-small cell lung cancer metastatic | Third line treatment Non-small cell lung cancer metastatic
Item
the current approved indication of gefitinib is 2nd or 3rd line monotherapy for recurrent or metastatic nsclc. however, in practice with off-label indication, it can also be used as a 1st line treatment at the patient's own expenses. thus, in this trial gefitinib retreatment will be 3rd line or more.
boolean
C3146298 (UMLS CUI [1,1])
C1122962 (UMLS CUI [1,2])
C1710038 (UMLS CUI [2,1])
C0278517 (UMLS CUI [2,2])
C2986605 (UMLS CUI [3,1])
C0278517 (UMLS CUI [3,2])
C1710038 (UMLS CUI [4,1])
C0278987 (UMLS CUI [4,2])
C2986605 (UMLS CUI [5,1])
C0278987 (UMLS CUI [5,2])
Measurable lesion | Prior radiation therapy Absent Measurable lesion Quantity | Exception Disease Progression
Item
measurable lesion according to response evaluation criteria in solid tumors(recist) with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
boolean
C1513041 (UMLS CUI [1])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0242656 (UMLS CUI [3,2])
Informed Consent
Item
provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lung Diseases, Interstitial
Item
evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
boolean
C0206062 (UMLS CUI [1])
Life Expectancy
Item
expected life expectancy less than 2 months
boolean
C0023671 (UMLS CUI [1])
Severe allergy Gefitinib | Severe allergy Gefitinib Excipient
Item
known severe hypersensitivity to gefitinib or any of the excipients of this product
boolean
C2945656 (UMLS CUI [1,1])
C1122962 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C1122962 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Resolution Lacking | Toxicity chronic CTCAE Grades | Etiology Cancer treatment
Item
any unresolved chronic toxicity greater that common terminology criteria (ctc) grade 2 from previous anticancer therapy
boolean
C1514893 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0920425 (UMLS CUI [3,2])
Systemic disease Severe | Systemic disease Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Uncompensated | Heart Disease Uncompensated | Liver disease Uncompensated | Kidney Disease Uncompensated
Item
as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0035204 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0023895 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0035204 (UMLS CUI [7,1])
C0205433 (UMLS CUI [7,2])
C0018799 (UMLS CUI [8,1])
C0205433 (UMLS CUI [8,2])
C0023895 (UMLS CUI [9,1])
C0205433 (UMLS CUI [9,2])
C0022658 (UMLS CUI [10,1])
C0205433 (UMLS CUI [10,2])
Serum bilirubin increased
Item
serum bilirubin greater than 3 times the upper limit of reference range (ulrr)
boolean
C0859062 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present
Item
aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt) ≥ 2.5 x upper limit normal (uln) if no demonstrable liver metastases (or >5 x in presence of liver metastases)
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0494165 (UMLS CUI [4,1])
C0150312 (UMLS CUI [4,2])
Disease Clinical Significance Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable
Item
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3640815 (UMLS CUI [1,4])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
pregnancy or breast-feeding women (women of child¬bearing potential). women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Operative Surgical Procedures Absent CNS metastases | Therapeutic radiology procedure Absent CNS metastases
Item
newly diagnosed central nervous system (cns) metastases that have not yet been treated with surgery and/or radiation. patients with previously diagnosed and treated cns metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (no steroid therapy or steroid dose being tapered) for at least 2 weeks
boolean
C0543467 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0686377 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0686377 (UMLS CUI [2,3])
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