ID

23712

Beskrivning

Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00905983

Länk

https://clinicaltrials.gov/show/NCT00905983

Nyckelord

Versioner (1)
  1. 2017-07-11 2017-07-11 -
Uppladdad den

11 juli 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00905983

Engelsk

Eligibility Carcinoma, Non-Small-Cell Lung NCT00905983

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of advanced nsclc.
Beskrivning

Non-Small Cell Lung Carcinoma Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
stage iii with pleural effusion and stage iv.
Beskrivning

TNM clinical staging | Pleural effusion

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C0032227
patients are 70 years old.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients with 1 > ecog ps =1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
patients must have at least one measurable lesion, no previously irradiated.
Beskrivning

Measurable Disease Quantity | Therapeutic radiology procedure Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
life expectancy of at least 12 weeks.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
adequate organ function according to the following criteria:
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
bone marrow: anc >= 2.0x10(9)cells/l; platelet count >= 100x10(9)cells/l; leukocyte count >= 4000x10(6)/l; hemoglobin >= 10 g/dl.
Beskrivning

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | White Blood Cell Count procedure | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0023508
UMLS CUI [5]
C0518015
liver function: bilirubin <= 1.5 x uln; alkaline phosphatase <= 5 x uln;ast and alt <= 1.5 x uln.
Beskrivning

Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201850
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
renal function: serum creatinine <= 2mg/dl.
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic chemotherapy for advanced disease.
Beskrivning

Systemic Chemotherapy Advanced disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0679246
patients with symptomatic brain metastases.
Beskrivning

Metastatic malignant neoplasm to brain Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
no measurable bone metastases or malignant pleural effusion as only measurable lesion.
Beskrivning

Secondary malignant neoplasm of bone Measurable | Malignant Pleural Effusion Measurable Disease Alone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C1513040
UMLS CUI [2,1]
C0080032
UMLS CUI [2,2]
C1513041
UMLS CUI [2,3]
C0205171
history of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
Beskrivning

Malignant Neoplasms | Curative treatment Carcinoma in situ of uterine cervix | Curative treatment Malignant Neoplasms | Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1273390
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1273390
UMLS CUI [3,2]
C0006826
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0332296
history of hypersensitivity reaction to study drugs.
Beskrivning

Hypersensitivity Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
concurrent treatment with other experimental drugs.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
current peripheral neuropathy nci grade 2.
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
participation in clinical trials within 30 days of study entry.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
major surgery, open biopsy or traumatic lesion 28 days before to study start.
Beskrivning

Major surgery | Incisional biopsy | Traumatic lesion

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C1402312
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00905983

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced
Item
histologically or cytologically confirmed diagnosis of advanced nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
TNM clinical staging | Pleural effusion
Item
stage iii with pleural effusion and stage iv.
boolean
C3258246 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
Age
Item
patients are 70 years old.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
patients with 1 > ecog ps =1.
boolean
C1520224 (UMLS CUI [1])
Measurable Disease Quantity | Therapeutic radiology procedure Absent
Item
patients must have at least one measurable lesion, no previously irradiated.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Organ function
Item
adequate organ function according to the following criteria:
boolean
C0678852 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | White Blood Cell Count procedure | Hemoglobin measurement
Item
bone marrow: anc >= 2.0x10(9)cells/l; platelet count >= 100x10(9)cells/l; leukocyte count >= 4000x10(6)/l; hemoglobin >= 10 g/dl.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
liver function: bilirubin <= 1.5 x uln; alkaline phosphatase <= 5 x uln;ast and alt <= 1.5 x uln.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
Renal function | Creatinine measurement, serum
Item
renal function: serum creatinine <= 2mg/dl.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Systemic Chemotherapy Advanced disease
Item
prior systemic chemotherapy for advanced disease.
boolean
C1883256 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Symptomatic
Item
patients with symptomatic brain metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Secondary malignant neoplasm of bone Measurable | Malignant Pleural Effusion Measurable Disease Alone
Item
no measurable bone metastases or malignant pleural effusion as only measurable lesion.
boolean
C0153690 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0080032 (UMLS CUI [2,1])
C1513041 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
Malignant Neoplasms | Curative treatment Carcinoma in situ of uterine cervix | Curative treatment Malignant Neoplasms | Disease Free of
Item
history of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
boolean
C0006826 (UMLS CUI [1])
C1273390 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1273390 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0332296 (UMLS CUI [4,2])
Hypersensitivity Investigational New Drugs
Item
history of hypersensitivity reaction to study drugs.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Investigational New Drugs
Item
concurrent treatment with other experimental drugs.
boolean
C0013230 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
current peripheral neuropathy nci grade 2.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Study Subject Participation Status
Item
participation in clinical trials within 30 days of study entry.
boolean
C2348568 (UMLS CUI [1])
Major surgery | Incisional biopsy | Traumatic lesion
Item
major surgery, open biopsy or traumatic lesion 28 days before to study start.
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C1402312 (UMLS CUI [3])
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