ID

44308

Beschreibung

A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01497041

Link

https://clinicaltrials.gov/show/NCT01497041

Stichworte

Versionen (2)
  1. 16.10.19 16.10.19 -
  2. 20.09.21 20.09.21 -
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See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01497041

Englisch

Eligibility Carcinoma, Non-Small-Cell Lung NCT01497041

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically
Beschreibung

Adenocarcinoma Absent | Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001418
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0007131
2. patients must be ≥ 18 years old of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. ecog performance status ≤ 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
4. estimated life expectancy of more than 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
5. treatment with only one prior chemotherapy
Beschreibung

Prior Chemotherapy Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
6. at least one lesion that can be measured by imaging (ct/mri) according to the response evaluation criteria in solid tumors (recist v1.1)
Beschreibung

Measurable lesion Quantity CT | Measurable lesion Quantity MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0024485
7. adequate bone marrow function (absolute neutrophil count [anc] ≥ 1,500/µl, hemoglobin
Beschreibung

Bone Marrow function | Absolute neutrophil count | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0518015
≥ 9.0 g/dl [correction by transfusion is acceptable], and platelets ≥ 100,000/µl)
Beschreibung

Correction Transfusion Acceptable | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1947976
UMLS CUI [1,2]
C0005841
UMLS CUI [1,3]
C1879533
UMLS CUI [2]
C0032181
8. adequate kidney function (serum creatinine < 1.5 x upper limit of normal [uln])
Beschreibung

Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
9. adequate liver function (serum total bilirubin < 1.5xuln; serum transaminases levels < 2.5xunl)
Beschreibung

Liver function | Serum total bilirubin measurement | Transaminase Assay

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0919834
10. provision of fully informed consent prior to any study specific procedures
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
2. patients who received prior chemotherapy including paclitaxel or docetaxel
Beschreibung

Prior Chemotherapy | Paclitaxel | docetaxel

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0144576
UMLS CUI [3]
C0246415
3. patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
Beschreibung

Second Primary Cancer | Exception Skin carcinoma Treated | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0280100
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
4. patients with defect of central nervous system (cns) or any psychiatric disorders and cns metastases
Beschreibung

Defect Central Nervous System | Mental disorders | CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457869
UMLS CUI [1,2]
C3714787
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0686377
5. other serious illness or medical conditions a. clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [nyha class iii or iv], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 av block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry b. liver cirrhosis (≥ child-pugh class b) c. history of significant neurologic or psychiatric disorders including dementia or seizures d. active uncontrolled infection e. other serious underlying medical conditions which could impair the ability of the patient to participate in the study
Beschreibung

Illness Serious | Medical condition Serious | Heart Disease | Congestive heart failure Uncontrolled New York Heart Association Classification | Therapeutic procedure Unsuccessful | Coronary Artery Disease Symptomatic | Angina, Unstable | Myocardial Infarction | Abnormal cardiac conduction | Second degree atrioventricular block | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Uncontrolled hypertension | Liver Cirrhosis Child-Pugh Classification | Nervous system disorder | Mental disorders | Dementia | Seizures | Communicable Disease Uncontrolled | Other medical condition Impairing Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0018799
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C1275491
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1272705
UMLS CUI [6,1]
C1956346
UMLS CUI [6,2]
C0231220
UMLS CUI [7]
C0002965
UMLS CUI [8]
C0027051
UMLS CUI [9]
C0232219
UMLS CUI [10]
C0264906
UMLS CUI [11,1]
C0003811
UMLS CUI [11,2]
C0205404
UMLS CUI [11,3]
C1514873
UMLS CUI [11,4]
C0013227
UMLS CUI [12]
C1868885
UMLS CUI [13,1]
C0023890
UMLS CUI [13,2]
C4050412
UMLS CUI [14]
C0027765
UMLS CUI [15]
C0004936
UMLS CUI [16]
C0497327
UMLS CUI [17]
C0036572
UMLS CUI [18,1]
C0009450
UMLS CUI [18,2]
C0205318
UMLS CUI [19,1]
C3843040
UMLS CUI [19,2]
C0221099
UMLS CUI [19,3]
C2348568
6. concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
Beschreibung

Investigational New Drugs | Chemotherapy | Hormone Therapy | Immunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0021083
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Ähnliche Modelle

Eligibility Carcinoma, Non-Small-Cell Lung NCT01497041

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma Absent | Non-Small Cell Lung Carcinoma
Item
1. patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically
boolean
C0001418 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2])
Age
Item
2. patients must be ≥ 18 years old of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
4. estimated life expectancy of more than 3 months
boolean
C0023671 (UMLS CUI [1])
Prior Chemotherapy Quantity
Item
5. treatment with only one prior chemotherapy
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Measurable lesion Quantity CT | Measurable lesion Quantity MRI
Item
6. at least one lesion that can be measured by imaging (ct/mri) according to the response evaluation criteria in solid tumors (recist v1.1)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Bone Marrow function | Absolute neutrophil count | Hemoglobin measurement
Item
7. adequate bone marrow function (absolute neutrophil count [anc] ≥ 1,500/µl, hemoglobin
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Correction Transfusion Acceptable | Platelet Count measurement
Item
≥ 9.0 g/dl [correction by transfusion is acceptable], and platelets ≥ 100,000/µl)
boolean
C1947976 (UMLS CUI [1,1])
C0005841 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
C0032181 (UMLS CUI [2])
Renal function | Creatinine measurement, serum
Item
8. adequate kidney function (serum creatinine < 1.5 x upper limit of normal [uln])
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Transaminase Assay
Item
9. adequate liver function (serum total bilirubin < 1.5xuln; serum transaminases levels < 2.5xunl)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0919834 (UMLS CUI [3])
Informed Consent
Item
10. provision of fully informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
1. pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Prior Chemotherapy | Paclitaxel | docetaxel
Item
2. patients who received prior chemotherapy including paclitaxel or docetaxel
boolean
C1514457 (UMLS CUI [1])
C0144576 (UMLS CUI [2])
C0246415 (UMLS CUI [3])
Second Primary Cancer | Exception Skin carcinoma Treated | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration
Item
3. patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0280100 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Defect Central Nervous System | Mental disorders | CNS metastases
Item
4. patients with defect of central nervous system (cns) or any psychiatric disorders and cns metastases
boolean
C1457869 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2])
C0686377 (UMLS CUI [3])
Illness Serious | Medical condition Serious | Heart Disease | Congestive heart failure Uncontrolled New York Heart Association Classification | Therapeutic procedure Unsuccessful | Coronary Artery Disease Symptomatic | Angina, Unstable | Myocardial Infarction | Abnormal cardiac conduction | Second degree atrioventricular block | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Uncontrolled hypertension | Liver Cirrhosis Child-Pugh Classification | Nervous system disorder | Mental disorders | Dementia | Seizures | Communicable Disease Uncontrolled | Other medical condition Impairing Study Subject Participation Status
Item
5. other serious illness or medical conditions a. clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [nyha class iii or iv], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 av block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry b. liver cirrhosis (≥ child-pugh class b) c. history of significant neurologic or psychiatric disorders including dementia or seizures d. active uncontrolled infection e. other serious underlying medical conditions which could impair the ability of the patient to participate in the study
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C1275491 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C1272705 (UMLS CUI [5,2])
C1956346 (UMLS CUI [6,1])
C0231220 (UMLS CUI [6,2])
C0002965 (UMLS CUI [7])
C0027051 (UMLS CUI [8])
C0232219 (UMLS CUI [9])
C0264906 (UMLS CUI [10])
C0003811 (UMLS CUI [11,1])
C0205404 (UMLS CUI [11,2])
C1514873 (UMLS CUI [11,3])
C0013227 (UMLS CUI [11,4])
C1868885 (UMLS CUI [12])
C0023890 (UMLS CUI [13,1])
C4050412 (UMLS CUI [13,2])
C0027765 (UMLS CUI [14])
C0004936 (UMLS CUI [15])
C0497327 (UMLS CUI [16])
C0036572 (UMLS CUI [17])
C0009450 (UMLS CUI [18,1])
C0205318 (UMLS CUI [18,2])
C3843040 (UMLS CUI [19,1])
C0221099 (UMLS CUI [19,2])
C2348568 (UMLS CUI [19,3])
Investigational New Drugs | Chemotherapy | Hormone Therapy | Immunotherapy
Item
6. concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
boolean
C0013230 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
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