ID

31042

Beschrijving

Erlotinib as First-line Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) for Patients Unfit for Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00452075

Link

https://clinicaltrials.gov/show/NCT00452075

Trefwoorden

Versies (1)
  1. 12-07-18 12-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

12 juli 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00452075

Engels

Eligibility Non Small Cell Lung Cancer NCT00452075

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (stage iiib or stage iv) nsclc.
Beschrijving

Non-small cell lung cancer recurrent TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | NSCLC recurrent Advanced Locally Inoperable | NSCLC metastatic Advanced Locally Inoperable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0278517
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0278517
UMLS CUI [3,2]
C0205179
UMLS CUI [3,3]
C1517927
UMLS CUI [3,4]
C0205187
UMLS CUI [4,1]
C0278987
UMLS CUI [4,2]
C0205179
UMLS CUI [4,3]
C1517927
UMLS CUI [4,4]
C0205187
chemo-naïve patients.
Beschrijving

Chemotherapy naive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0919936
patients who are in the investigator's opinion not medically suitable for chemotherapy.
Beschrijving

Patients Medically unfit Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3841806
UMLS CUI [1,3]
C0392920
measurable disease according to the recist criteria.
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
ecog performance status of 0 - 3.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 12 weeks.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
patients must be able to take oral medication.
Beschrijving

Able to swallow Oral medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
serum calcium within normal ranges
Beschrijving

Normal serum calcium level

Datatype

boolean

Alias
UMLS CUI [1]
C0580486
≥ 4 weeks since prior surgery or radiation therapy
Beschrijving

Operative Surgical Procedures | Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C1522449
for all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting therapy and must use effective contraception
Beschrijving

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
18 years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
written (signed) informed consent to participate in the study
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic antitumor therapy
Beschrijving

Cancer treatment Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
any unstable systemic disease which according to the investigator contraindicates the use of the study drug render the subject at high risk from treatment complications (including active infection, unstable angina, myocardial infarction within the previous month, inflammatory bowel disease, hepatic disease with serum bilirubin ≥ 2 upper limit of normal (uln) or ast and/or alt ≥ 2 x uln (or ≥ 5 x uln if clearly attributable to liver metastasis), renal disease with acute renal failure or serum creatinine ≥ 5 x uln.
Beschrijving

Systemic disease Unstable | Medical contraindication Investigational New Drugs | High risk of Complications of treatment | Communicable Disease | Angina, Unstable | Myocardial Infarction | Inflammatory Bowel Diseases | Liver diseases | Serum bilirubin increased | Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Secondary malignant neoplasm of liver | Kidney Diseases | Kidney Failure | Serum creatinine raised

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0679861
UMLS CUI [4]
C0009450
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0027051
UMLS CUI [7]
C0021390
UMLS CUI [8]
C0023895
UMLS CUI [9]
C0859062
UMLS CUI [10]
C0151904
UMLS CUI [11]
C0151905
UMLS CUI [12,1]
C0439849
UMLS CUI [12,2]
C0494165
UMLS CUI [13]
C0022658
UMLS CUI [14]
C0035078
UMLS CUI [15]
C0700225
any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
Beschrijving

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
nursing mothers or pregnant woman.
Beschrijving

Breast Feeding | Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
hypersensitivity to tarceva or co-formulants.
Beschrijving

Hypersensitivity Tarceva | Hypersensitivity Pharmaceutical Formulation Tarceva Similar

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1135136
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705957
UMLS CUI [2,3]
C1135136
UMLS CUI [2,4]
C2348205
patients with brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation.
Beschrijving

Metastatic malignant neoplasm to brain | Compression of spinal cord | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0037926
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0332197
patients with brain metastasis or spinal cord compression that not are in a stable condition despite treatment with steroids.
Beschrijving

Metastatic malignant neoplasm to brain | Compression of spinal cord | Patient's condition unstable | Steroid therapy Resistant

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0037926
UMLS CUI [3]
C0438114
UMLS CUI [4,1]
C0149783
UMLS CUI [4,2]
C0332325
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00452075

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-small cell lung cancer recurrent TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | NSCLC recurrent Advanced Locally Inoperable | NSCLC metastatic Advanced Locally Inoperable
Item
histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (stage iiib or stage iv) nsclc.
boolean
C0278517 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0278517 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C0205187 (UMLS CUI [3,4])
C0278987 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
C1517927 (UMLS CUI [4,3])
C0205187 (UMLS CUI [4,4])
Chemotherapy naive
Item
chemo-naïve patients.
boolean
C0392920 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Patients Medically unfit Chemotherapy
Item
patients who are in the investigator's opinion not medically suitable for chemotherapy.
boolean
C0030705 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease according to the recist criteria.
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 - 3.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Able to swallow Oral medication
Item
patients must be able to take oral medication.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Normal serum calcium level
Item
serum calcium within normal ranges
boolean
C0580486 (UMLS CUI [1])
Operative Surgical Procedures | Therapeutic radiology procedure
Item
≥ 4 weeks since prior surgery or radiation therapy
boolean
C0543467 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
for all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting therapy and must use effective contraception
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written (signed) informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Systemic
Item
prior systemic antitumor therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Systemic disease Unstable | Medical contraindication Investigational New Drugs | High risk of Complications of treatment | Communicable Disease | Angina, Unstable | Myocardial Infarction | Inflammatory Bowel Diseases | Liver diseases | Serum bilirubin increased | Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Secondary malignant neoplasm of liver | Kidney Diseases | Kidney Failure | Serum creatinine raised
Item
any unstable systemic disease which according to the investigator contraindicates the use of the study drug render the subject at high risk from treatment complications (including active infection, unstable angina, myocardial infarction within the previous month, inflammatory bowel disease, hepatic disease with serum bilirubin ≥ 2 upper limit of normal (uln) or ast and/or alt ≥ 2 x uln (or ≥ 5 x uln if clearly attributable to liver metastasis), renal disease with acute renal failure or serum creatinine ≥ 5 x uln.
boolean
C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0679861 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0021390 (UMLS CUI [7])
C0023895 (UMLS CUI [8])
C0859062 (UMLS CUI [9])
C0151904 (UMLS CUI [10])
C0151905 (UMLS CUI [11])
C0439849 (UMLS CUI [12,1])
C0494165 (UMLS CUI [12,2])
C0022658 (UMLS CUI [13])
C0035078 (UMLS CUI [14])
C0700225 (UMLS CUI [15])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Breast Feeding | Pregnancy
Item
nursing mothers or pregnant woman.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Hypersensitivity Tarceva | Hypersensitivity Pharmaceutical Formulation Tarceva Similar
Item
hypersensitivity to tarceva or co-formulants.
boolean
C0020517 (UMLS CUI [1,1])
C1135136 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705957 (UMLS CUI [2,2])
C1135136 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
Metastatic malignant neoplasm to brain | Compression of spinal cord | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent
Item
patients with brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation.
boolean
C0220650 (UMLS CUI [1])
C0037926 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain | Compression of spinal cord | Patient's condition unstable | Steroid therapy Resistant
Item
patients with brain metastasis or spinal cord compression that not are in a stable condition despite treatment with steroids.
boolean
C0220650 (UMLS CUI [1])
C0037926 (UMLS CUI [2])
C0438114 (UMLS CUI [3])
C0149783 (UMLS CUI [4,1])
C0332325 (UMLS CUI [4,2])
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