ID

21450

Beskrivning

Neoadjuvant, Tarceva, Surgery for Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00254384

Länk

https://clinicaltrials.gov/show/NCT00254384

Nyckelord

Versioner (1)
  1. 2017-04-21 2017-04-21 -
Uppladdad den

21 april 2017

DOI

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Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00254384

Engelsk

Eligibility Lung Cancer NCT00254384

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have histologically or cytologically confirmed diagnosis of stage i, ii or iii non-small cell lung cancer. tissue blocks or slides will be requested.
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging | Sectioning of tissue block | Special stained specimen slides to examine tissue

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C2316371
UMLS CUI [3]
C3865498
2. patients must have surgically resectable disease and may not be treated with prior chemotherapy or radiation.
Beskrivning

Disease Resectable | Chemotherapy Absent | Therapeutic radiology procedure Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514888
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
3. patients must be able to tolerate systemic chemotherapy prior to surgical resection.
Beskrivning

Systemic Chemotherapy Receive Able | Excision

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0085732
UMLS CUI [2]
C0728940
4. age >=18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. no acute intercurrent illness or infection.
Beskrivning

Comorbidity Absent | Communicable Disease Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0332197
6. ecog performance status 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
7. normal organ and marrow function defined as: a) leukocytes >=3,000/ul, anc>=1,500/ul, platelets>=100,000/ul, hemoglobin>=8g/dl, creatinine w/in normal institutional limits or b) creatinine clearance>=60 ml/min/1.73 m**2 for patients with creatinine levels above institutional normal, bilirubin w/in normal institutional limits, alk phos<=2.5xuln and ast or alt<=1.5xuln. if alk phos>2.5xuln but <=5xuln, pt is eligible if ast or alt<=uln. if ast or alt>1.5xuln but <=5xuln, pt is eligible if alk phos is <=uln.
Beskrivning

Organ function | Bone Marrow function | White Blood Cell Count | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Serum creatinine normal | Creatinine clearance measurement | Serum creatinine raised | Serum bilirubin normal | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0518015
UMLS CUI [7]
C0438244
UMLS CUI [8]
C0373595
UMLS CUI [9]
C0700225
UMLS CUI [10]
C0428443
UMLS CUI [11]
C0201850
UMLS CUI [12]
C0201899
UMLS CUI [13]
C0201836
8. prior to study enrollment, all women of child-bearing potential must have a negative pregnancy test. women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 2 months after the completion of therapy. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Beskrivning

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C2985296
UMLS CUI [5]
C0004764
UMLS CUI [6]
C0036899
9. patients with a history of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free, are eligible.
Beskrivning

Skin carcinoma | Malignant Neoplasms Treated | Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1]
C0699893
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332296
10. ability to understand and the willingness to sign a written informed consent document.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have had prior chemotherapy or radiotherapy for lung cancer.
Beskrivning

Chemotherapy Carcinoma of lung | Therapeutic radiology procedure Carcinoma of lung

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0684249
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0684249
2. patients may not be receiving any other investigational agents within 30 days of trial entry, including anti-egfr drugs.
Beskrivning

Investigational New Drugs | Pharmaceutical Preparations Against Epidermal Growth Factor Receptor

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0034802
3. patient has signs or symptoms of acute infection requiring systemic therapy.
Beskrivning

Communicable Disease Sign or Symptom | Systemic therapy Patient need for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C3540840
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0686904
4. patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent.
Beskrivning

Confusion | Disorientation | Mental disorder Major | Informed Consent Limited

Datatyp

boolean

Alias
UMLS CUI [1]
C0009676
UMLS CUI [2]
C0233407
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205164
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0439801
5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (new york heart association functional classification class ii or worse), unstable angina pectoris, serious or clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Beskrivning

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Serious | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0742758
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205404
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0439801
6. patients refusing to sign the informed consent.
Beskrivning

Informed Consent Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
7. patients with pre-existing peripheral neuropathy nci ctc grade 2 or worse.
Beskrivning

Peripheral Neuropathy Pre-existing CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
8. patients must not be pregnant or breast-feeding and all (male and female) must use a contraceptive method deemed acceptable by the investigator while receiving active treatment in the study and for up to two months following completion of therapy.
Beskrivning

Pregnancy | Breast Feeding | Contraceptive methods Patient need for

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0686904
9. patients with a history of severe hypersensitivity reaction to taxotere® and or polysorbate 80 must be excluded.
Beskrivning

Hypersensitivity Severe Taxotere | Hypersensitivity Severe Polysorbate 80

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0699967
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0032601
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Similar models

Eligibility Lung Cancer NCT00254384

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Sectioning of tissue block | Special stained specimen slides to examine tissue
Item
1. patients must have histologically or cytologically confirmed diagnosis of stage i, ii or iii non-small cell lung cancer. tissue blocks or slides will be requested.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C2316371 (UMLS CUI [2])
C3865498 (UMLS CUI [3])
Disease Resectable | Chemotherapy Absent | Therapeutic radiology procedure Absent
Item
2. patients must have surgically resectable disease and may not be treated with prior chemotherapy or radiation.
boolean
C0012634 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Systemic Chemotherapy Receive Able | Excision
Item
3. patients must be able to tolerate systemic chemotherapy prior to surgical resection.
boolean
C1883256 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0728940 (UMLS CUI [2])
Age
Item
4. age >=18 years
boolean
C0001779 (UMLS CUI [1])
Comorbidity Absent | Communicable Disease Absent
Item
5. no acute intercurrent illness or infection.
boolean
C0009488 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ECOG performance status
Item
6. ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function | White Blood Cell Count | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Serum creatinine normal | Creatinine clearance measurement | Serum creatinine raised | Serum bilirubin normal | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
7. normal organ and marrow function defined as: a) leukocytes >=3,000/ul, anc>=1,500/ul, platelets>=100,000/ul, hemoglobin>=8g/dl, creatinine w/in normal institutional limits or b) creatinine clearance>=60 ml/min/1.73 m**2 for patients with creatinine levels above institutional normal, bilirubin w/in normal institutional limits, alk phos<=2.5xuln and ast or alt<=1.5xuln. if alk phos>2.5xuln but <=5xuln, pt is eligible if ast or alt<=uln. if ast or alt>1.5xuln but <=5xuln, pt is eligible if alk phos is <=uln.
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0518015 (UMLS CUI [6])
C0438244 (UMLS CUI [7])
C0373595 (UMLS CUI [8])
C0700225 (UMLS CUI [9])
C0428443 (UMLS CUI [10])
C0201850 (UMLS CUI [11])
C0201899 (UMLS CUI [12])
C0201836 (UMLS CUI [13])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
8. prior to study enrollment, all women of child-bearing potential must have a negative pregnancy test. women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 2 months after the completion of therapy. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C2985296 (UMLS CUI [4])
C0004764 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
Skin carcinoma | Malignant Neoplasms Treated | Disease Free of
Item
9. patients with a history of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free, are eligible.
boolean
C0699893 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
Informed Consent
Item
10. ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Carcinoma of lung | Therapeutic radiology procedure Carcinoma of lung
Item
1. patients who have had prior chemotherapy or radiotherapy for lung cancer.
boolean
C0392920 (UMLS CUI [1,1])
C0684249 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0684249 (UMLS CUI [2,2])
Investigational New Drugs | Pharmaceutical Preparations Against Epidermal Growth Factor Receptor
Item
2. patients may not be receiving any other investigational agents within 30 days of trial entry, including anti-egfr drugs.
boolean
C0013230 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0034802 (UMLS CUI [2,3])
Communicable Disease Sign or Symptom | Systemic therapy Patient need for
Item
3. patient has signs or symptoms of acute infection requiring systemic therapy.
boolean
C0009450 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Confusion | Disorientation | Mental disorder Major | Informed Consent Limited
Item
4. patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent.
boolean
C0009676 (UMLS CUI [1])
C0233407 (UMLS CUI [2])
C0004936 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Serious | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (new york heart association functional classification class ii or worse), unstable angina pectoris, serious or clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0004936 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Informed Consent Refused
Item
6. patients refusing to sign the informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
7. patients with pre-existing peripheral neuropathy nci ctc grade 2 or worse.
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Contraceptive methods Patient need for
Item
8. patients must not be pregnant or breast-feeding and all (male and female) must use a contraceptive method deemed acceptable by the investigator while receiving active treatment in the study and for up to two months following completion of therapy.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Hypersensitivity Severe Taxotere | Hypersensitivity Severe Polysorbate 80
Item
9. patients with a history of severe hypersensitivity reaction to taxotere® and or polysorbate 80 must be excluded.
boolean
C0020517 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0699967 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0032601 (UMLS CUI [2,3])
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