ID

31051

Beschreibung

Chemotherapy and Radiation in Treating Patients With Stage 3 Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00686959

Link

https://clinicaltrials.gov/show/NCT00686959

Stichworte

Versionen (2)
  1. 13.07.18 13.07.18 -
  2. 13.07.18 13.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

13. Juli 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Non Small Cell Lung Cancer NCT00686959

Englisch

Eligibility Non Small Cell Lung Cancer NCT00686959

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
you must have stage 3a or 3b non-small cell lung cancer of the non-squamous type
Beschreibung

Non-squamous non-small cell lung cancer TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4324656
UMLS CUI [1,2]
C3258246
you must have measureable tumor lesions according to the response evaluation criteria in solid tumors (recist) guidelines or disease that can be evaluated on ct scan
Beschreibung

Measurable lesion | Evaluable Disease CT scan

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1516986
UMLS CUI [2,2]
C0040405
you must at least be able to physically be mobile, take care of yourself and must be up and about and able to perform light activities such as light housework or office work
Beschreibung

Study Subject Fully mobile | Ability to perform activities of everyday life

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0425246
UMLS CUI [2]
C0562507
18 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
you have lost no more than 10% of body weight in the previous three months
Beschreibung

Weight decreased Percentage Timespan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
women must be sterile, postmenopausal or on contraception and men must be sterile or on contraception
Beschreibung

Gender Contraceptive methods | Female Sterilization | Postmenopausal state | Male sterilization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0024559
your test results assessing the function of your blood forming tissue, kidneys, liver and lungs are satisfactory
Beschreibung

Hematologic function Tests | Kidney Function Tests | Liver Function Tests | Pulmonary function tests

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0392366
UMLS CUI [2]
C0022662
UMLS CUI [3]
C0023901
UMLS CUI [4]
C0024119
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
you cannot have other on-going illnesses including active infections, recent heart problems or psychiatric illnesses
Beschreibung

Comorbidity | Communicable Diseases | HEART PROBLEM | Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0795691
UMLS CUI [4]
C0004936
Cancer Other Primary site Treatment required for | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in Situ
Beschreibung

Cancer Other Primary site Treatment required for | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in Situ

Datentyp

text

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0475447
UMLS CUI [1,3]
C0332121
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0007099
you are unable to take vitamins (including injections of vitamin b12) or oral cortisone medication
Beschreibung

Use of Vitamins Unable | Vitamin B 12 Injection Unable | Cortisone Oral Route of Drug administration Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0042890
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0042845
UMLS CUI [2,2]
C1828121
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0010137
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C1299582
you cannot have had a heart attack or other cardiac issues within 6 months of the trial
Beschreibung

Myocardial Infarction | HEART PROBLEM

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0795691
you cannot have received other investigational drugs within the last 30 days
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
you are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents.
Beschreibung

Aspirin U/day Unable to discontinue | Non-Steroidal Anti-Inflammatory Agents Unable to discontinue

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0456683
UMLS CUI [1,3]
C1548265
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1548265
you cannot have had previous chest radiation, however, other prior radiation is allowed if it was at least 30 days prior to the trial and limited in extent.
Beschreibung

Radiotherapy to thorax

Datentyp

boolean

Alias
UMLS CUI [1]
C4038705
you cannot have a radiation treatment plan that would expose more than 35% of your unaffected lung to 20 gy or more of radiation
Beschreibung

Lung Percentage Exposure to Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024109
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0332157
UMLS CUI [1,4]
C1522449
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Ähnliche Modelle

Eligibility Non Small Cell Lung Cancer NCT00686959

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-squamous non-small cell lung cancer TNM clinical staging
Item
you must have stage 3a or 3b non-small cell lung cancer of the non-squamous type
boolean
C4324656 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Measurable lesion | Evaluable Disease CT scan
Item
you must have measureable tumor lesions according to the response evaluation criteria in solid tumors (recist) guidelines or disease that can be evaluated on ct scan
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
Study Subject Fully mobile | Ability to perform activities of everyday life
Item
you must at least be able to physically be mobile, take care of yourself and must be up and about and able to perform light activities such as light housework or office work
boolean
C0681850 (UMLS CUI [1,1])
C0425246 (UMLS CUI [1,2])
C0562507 (UMLS CUI [2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Weight decreased Percentage Timespan
Item
you have lost no more than 10% of body weight in the previous three months
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Gender Contraceptive methods | Female Sterilization | Postmenopausal state | Male sterilization
Item
women must be sterile, postmenopausal or on contraception and men must be sterile or on contraception
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0024559 (UMLS CUI [4])
Hematologic function Tests | Kidney Function Tests | Liver Function Tests | Pulmonary function tests
Item
your test results assessing the function of your blood forming tissue, kidneys, liver and lungs are satisfactory
boolean
C0221130 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0022662 (UMLS CUI [2])
C0023901 (UMLS CUI [3])
C0024119 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Comorbidity | Communicable Diseases | HEART PROBLEM | Mental disorders
Item
you cannot have other on-going illnesses including active infections, recent heart problems or psychiatric illnesses
boolean
C0009488 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0795691 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
Cancer Other Primary site Treatment required for | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in Situ
Item
text
C1707251 (UMLS CUI [1,1])
C0475447 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007099 (UMLS CUI [3,3])
Use of Vitamins Unable | Vitamin B 12 Injection Unable | Cortisone Oral Route of Drug administration Unable
Item
you are unable to take vitamins (including injections of vitamin b12) or oral cortisone medication
boolean
C1524063 (UMLS CUI [1,1])
C0042890 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0042845 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0010137 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Myocardial Infarction | HEART PROBLEM
Item
you cannot have had a heart attack or other cardiac issues within 6 months of the trial
boolean
C0027051 (UMLS CUI [1])
C0795691 (UMLS CUI [2])
Investigational New Drugs
Item
you cannot have received other investigational drugs within the last 30 days
boolean
C0013230 (UMLS CUI [1])
Aspirin U/day Unable to discontinue | Non-Steroidal Anti-Inflammatory Agents Unable to discontinue
Item
you are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents.
boolean
C0004057 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C1548265 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
Radiotherapy to thorax
Item
you cannot have had previous chest radiation, however, other prior radiation is allowed if it was at least 30 days prior to the trial and limited in extent.
boolean
C4038705 (UMLS CUI [1])
Lung Percentage Exposure to Therapeutic radiology procedure
Item
you cannot have a radiation treatment plan that would expose more than 35% of your unaffected lung to 20 gy or more of radiation
boolean
C0024109 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
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