ID

31042

Beschreibung

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

Stichworte

Versionen (1)
  1. 12.07.18 12.07.18 -
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See clinicaltrials.gov

Hochgeladen am

12. Juli 2018

DOI

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Eligibility Non Small Cell Lung Cancer NCT00452075

Englisch

Eligibility Non Small Cell Lung Cancer NCT00452075

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

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.
Beschreibung

Chemotherapy naive

Datentyp

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.
Beschreibung

Patients Medically unfit Chemotherapy

Datentyp

boolean

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

Measurable Disease

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Life Expectancy

Datentyp

boolean

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

Able to swallow Oral medication

Datentyp

boolean

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

Normal serum calcium level

Datentyp

boolean

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

Operative Surgical Procedures | Therapeutic radiology procedure

Datentyp

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
Beschreibung

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic antitumor therapy
Beschreibung

Cancer treatment Systemic

Datentyp

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.
Beschreibung

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

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Breast Feeding | Pregnancy

Datentyp

boolean

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

Hypersensitivity Tarceva | Hypersensitivity Pharmaceutical Formulation Tarceva Similar

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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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Ähnliche Modelle

Eligibility Non Small Cell Lung Cancer NCT00452075

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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