ID

22138

Beschrijving

Alimta and Gemcitabine in Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00434135

Link

https://clinicaltrials.gov/show/NCT00434135

Trefwoorden

Versies (1)
  1. 21-05-17 21-05-17 -
Geüploaded op

21 mei 2017

DOI

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Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00434135

Engels

Eligibility Non-Small Cell Lung Cancer NCT00434135

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with histologically or cytologically confirmed locally advanced (stage iiib) or metastatic (stage iv) nsclc
Beschrijving

Non-Small Cell Lung Carcinoma Advanced Local TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C3258246
2. no previous adjuvant or palliative chemotherapy
Beschrijving

Adjuvant Chemotherapy Absent | Chemotherapy Palliative Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1285530
UMLS CUI [2,3]
C0332197
3. no previous radiotherapy
Beschrijving

Therapeutic radiology procedure Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332197
4. presence of at least one unidimensionally measurable lesion (appendix 2)
Beschrijving

Measurable lesion Linear Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
5. ecog performance status of 0 or 1 (appendix 3)
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
6. charlson score ≤ 2 (appendix 4)
Beschrijving

Charlson Comorbidity Index

Datatype

boolean

Alias
UMLS CUI [1]
C3714916
7. adequate bone marrow function (absolute neutrophil count ≥ 2 x 109/l, platelet count
Beschrijving

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
≥ 100 x 109/l, and hemoglobin level ≥ 100 g/l), and adequate liver function (bilirubin level < two times the upper limit of normal, ast and/or alt < three times the upper limit of normal, prothrombin time < 1.5 times control), and creatinine clearance ≥ 60 ml/min.
Beschrijving

Hemoglobin measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Prothrombin time | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0232741
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C1533047
UMLS CUI [7]
C0373595
8. absence of symptomatic cns metastases (patients with cerebral metastases treated with brain irradiation may be included), severe cardiac arrhythmia or heart failure, second or third degree heart block or acute myocardial infarction within 4 months prior to study entry.
Beschrijving

CNS metastases Symptomatic Absent | Irradiation of whole brain Cerebral metastasis | Cardiac Arrhythmia Severe | Heart failure Severe | Second degree atrioventricular block | Complete atrioventricular block | Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C2064932
UMLS CUI [2,2]
C0555278
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0264906
UMLS CUI [6]
C0151517
UMLS CUI [7]
C0027051
9. no major surgery or pleurodesis within 14 days prior to enrollment.
Beschrijving

Major surgery Absent | Pleurodesis Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0189557
UMLS CUI [2,2]
C0332197
10. life expectancy of at least 12 weeks.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
11. no previous or concurrent malignancy, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease-free for more than 5 years.
Beschrijving

Malignant Neoplasms Absent | Skin carcinoma inactive | Carcinoma in situ of uterine cervix inactive | Malignant Neoplasm Disease Free of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C0544452
UMLS CUI [3,1]
C0851140
UMLS CUI [3,2]
C0544452
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0332296
12. written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
Beschrijving

Systemic disease Unstable | Communicable Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Liver disease | Kidney Disease | Metabolic Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0009450
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0018802
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C0205404
UMLS CUI [6,3]
C1514873
UMLS CUI [6,4]
C0013227
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0022658
UMLS CUI [9]
C0025517
2. patients with clinically significant effusions.
Beschrijving

Effusion Clinical Significance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013687
UMLS CUI [1,2]
C2826293
3. any other malignancies within 5 years that could affect therapy evaluation
Beschrijving

Malignant Neoplasms Affecting Therapy Evaluation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1515410
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00434135

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Local TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging
Item
1. patients with histologically or cytologically confirmed locally advanced (stage iiib) or metastatic (stage iv) nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Adjuvant Chemotherapy Absent | Chemotherapy Palliative Absent
Item
2. no previous adjuvant or palliative chemotherapy
boolean
C0085533 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C1285530 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Therapeutic radiology procedure Absent
Item
3. no previous radiotherapy
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Measurable lesion Linear Quantity
Item
4. presence of at least one unidimensionally measurable lesion (appendix 2)
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
ECOG performance status
Item
5. ecog performance status of 0 or 1 (appendix 3)
boolean
C1520224 (UMLS CUI [1])
Charlson Comorbidity Index
Item
6. charlson score ≤ 2 (appendix 4)
boolean
C3714916 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
7. adequate bone marrow function (absolute neutrophil count ≥ 2 x 109/l, platelet count
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Hemoglobin measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Prothrombin time | Creatinine clearance measurement
Item
≥ 100 x 109/l, and hemoglobin level ≥ 100 g/l), and adequate liver function (bilirubin level < two times the upper limit of normal, ast and/or alt < three times the upper limit of normal, prothrombin time < 1.5 times control), and creatinine clearance ≥ 60 ml/min.
boolean
C0518015 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C1533047 (UMLS CUI [6])
C0373595 (UMLS CUI [7])
CNS metastases Symptomatic Absent | Irradiation of whole brain Cerebral metastasis | Cardiac Arrhythmia Severe | Heart failure Severe | Second degree atrioventricular block | Complete atrioventricular block | Myocardial Infarction
Item
8. absence of symptomatic cns metastases (patients with cerebral metastases treated with brain irradiation may be included), severe cardiac arrhythmia or heart failure, second or third degree heart block or acute myocardial infarction within 4 months prior to study entry.
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C2064932 (UMLS CUI [2,1])
C0555278 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0018801 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0264906 (UMLS CUI [5])
C0151517 (UMLS CUI [6])
C0027051 (UMLS CUI [7])
Major surgery Absent | Pleurodesis Absent
Item
9. no major surgery or pleurodesis within 14 days prior to enrollment.
boolean
C0679637 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0189557 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Life Expectancy
Item
10. life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Malignant Neoplasms Absent | Skin carcinoma inactive | Carcinoma in situ of uterine cervix inactive | Malignant Neoplasm Disease Free of
Item
11. no previous or concurrent malignancy, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease-free for more than 5 years.
boolean
C0006826 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0699893 (UMLS CUI [2,1])
C0544452 (UMLS CUI [2,2])
C0851140 (UMLS CUI [3,1])
C0544452 (UMLS CUI [3,2])
C0006826 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
Informed Consent
Item
12. written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic disease Unstable | Communicable Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Liver disease | Kidney Disease | Metabolic Diseases
Item
1. any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
boolean
C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0003811 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
C0013227 (UMLS CUI [6,4])
C0023895 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
Effusion Clinical Significance
Item
2. patients with clinically significant effusions.
boolean
C0013687 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Malignant Neoplasms Affecting Therapy Evaluation
Item
3. any other malignancies within 5 years that could affect therapy evaluation
boolean
C0006826 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1515410 (UMLS CUI [1,3])
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