ID

31182

Beschrijving

The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere) [SMART] Trial for Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00887315

Link

https://clinicaltrials.gov/show/NCT00887315

Trefwoorden

Versies (1)
  1. 25-07-18 25-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

25 juli 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00887315

Engels

Eligibility Non-small Cell Lung Cancer NCT00887315

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 years or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. life expectancy > 6 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
3. histologically or cytologically confirmed diagnosis of nsclc
Beschrijving

Non-Small Cell Lung Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
4. patients with ajcc stage iv cancer with distant metastases and without malignant pleural or pericardial effusion at diagnosis and before start of study
Beschrijving

TNM clinical staging | Distant metastasis | Malignant Pleural Effusion Absent | Malignant pericardial effusion Absent

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C1269798
UMLS CUI [3,1]
C0080032
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0220655
UMLS CUI [4,2]
C0332197
1. patients with pleural effusion that is transudative, cytologically negative, and non-bloody are eligible as long as they are stable and do not impair the ability to define tumor volumes.
Beschrijving

Hydrothorax | Pleural effusion Cytologic Negative | Pleural effusion Except Effusion pleural bloody | Patients Stable status

Datatype

boolean

Alias
UMLS CUI [1]
C0020312
UMLS CUI [2,1]
C0032227
UMLS CUI [2,2]
C0205471
UMLS CUI [2,3]
C1513916
UMLS CUI [3,1]
C0032227
UMLS CUI [3,2]
C0332300
UMLS CUI [3,3]
C0240784
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0205360
2. if a pleural effusion is too small for diagnostic thoracentesis, the patient will be eligible.
Beschrijving

Diagnostic thoracentesis Pleural effusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0843886
UMLS CUI [1,2]
C0032227
5. primary and regional nodal disease that is encompassable in a reasonable radiotherapy portal:
Beschrijving

Disorder of lymph node Primary Suitable Therapeutic radiology procedure | Disorder of lymph node regional Suitable Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0272394
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C3900053
UMLS CUI [1,4]
C1522449
UMLS CUI [2,1]
C0272394
UMLS CUI [2,2]
C0205147
UMLS CUI [2,3]
C3900053
UMLS CUI [2,4]
C1522449
6. patients with 1-5 sites of disease and amenable to rt therapy as seen on standard imaging (ct, mri, bone scan, pet scan)
Beschrijving

Disease Site Quantity | Disease Amenable Therapeutic radiology procedure Imaging | Disease Amenable Therapeutic radiology procedure CT | Disease Amenable Therapeutic radiology procedure MRI | Disease Amenable Therapeutic radiology procedure Bone scan | Disease Amenable Therapeutic radiology procedure PET scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C1522449
UMLS CUI [2,4]
C0011923
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C3900053
UMLS CUI [3,3]
C1522449
UMLS CUI [3,4]
C0040405
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C3900053
UMLS CUI [4,3]
C1522449
UMLS CUI [4,4]
C0024485
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C3900053
UMLS CUI [5,3]
C1522449
UMLS CUI [5,4]
C0203668
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C3900053
UMLS CUI [6,3]
C1522449
UMLS CUI [6,4]
C0032743
7. unidimensionally measurable disease (based on recist) is desirable but not strictly required.
Beschrijving

Measurable Disease Linear

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
8. patients with brain metastases are allowed as long as they meet all other inclusion criteria. brain metastases must be treated with whole brain radiotherapy and stereotactic radiosurgery or surgical resection followed by whole brain radiotherapy.
Beschrijving

Metastatic malignant neoplasm to brain | Whole brain radiation therapy | Stereotactic Radiosurgery | Excision Followed by Whole brain radiation therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1520143
UMLS CUI [3]
C3846112
UMLS CUI [4,1]
C0728940
UMLS CUI [4,2]
C0332283
UMLS CUI [4,3]
C1520143
9. ecog performance status <2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
10. no prior rt to currently involved tumor sites
Beschrijving

Absence Prior radiation therapy Tumor site Involved

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0279134
UMLS CUI [1,3]
C0475445
UMLS CUI [1,4]
C1314939
11. baseline peripheral neuropathy < grade 1
Beschrijving

Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
12. room air saturation (sao2) > 90%
Beschrijving

Oxygen saturation measurement on room air

Datatype

boolean

Alias
UMLS CUI [1,1]
C0523807
UMLS CUI [1,2]
C2709070
13. patients must have normal organ and marrow function
Beschrijving

Organ function | Bone Marrow function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
14. men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Beschrijving

Females & males of reproductive potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
15. signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
16. inclusion of women and minorities
Beschrijving

Gender | Minorities

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0026192
17. rt: patient must have a completed treatment plan approved by the protocol review team
Beschrijving

Therapeutic radiology procedure Treatment Plan Complete

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0599880
UMLS CUI [1,3]
C0205197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure (chf), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
Beschrijving

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
2. patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant chf are excluded. the exclusion of patients with active coronary heart disease will be at the discretion of the attending physician.
Beschrijving

Pulmonary Dysfunction | Cardiomyopathy | Congestive heart failure | Coronary heart disease Physician Decision

Datatype

boolean

Alias
UMLS CUI [1]
C1709770
UMLS CUI [2]
C0878544
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0010068
UMLS CUI [4,2]
C1709536
3. patients with significant atelectasis such that ct definition of the gross tumor volume (gtv) is difficult to determine.
Beschrijving

Atelectasis | Gross tumor volume CT Difficult

Datatype

boolean

Alias
UMLS CUI [1]
C0004144
UMLS CUI [2,1]
C0475645
UMLS CUI [2,2]
C0040405
UMLS CUI [2,3]
C0332218
4. < 1000 cc of tumor free lung.
Beschrijving

Lung Portion Free of Tumor

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024109
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0332296
UMLS CUI [1,4]
C0027651
5. tumor volume and location which requires a lung volume-ptv >40% to receive >20 gy (v20 <40%).
Beschrijving

Tumor Volume | Tumor Location | Requirement Lung volume PTV Percentage

Datatype

boolean

Alias
UMLS CUI [1]
C0475276
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1515974
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0231953
UMLS CUI [3,3]
C0454199
UMLS CUI [3,4]
C0439165
6. patients with exudative, bloody, or cytologically malignant effusions are not eligible.
Beschrijving

Exudative pleural effusion | Effusion pleural bloody | Pleural Effusion, Malignant

Datatype

boolean

Alias
UMLS CUI [1]
C3887491
UMLS CUI [2]
C0240784
UMLS CUI [3]
C0080032
7. pregnancy or breast feeding (women of child-bearing potential are eligible, but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
8. patients must have no uncontrolled active infection other than that not curable without treatment of their cancer.
Beschrijving

Communicable Disease Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
9. patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
Beschrijving

Severe allergy Docetaxel | Severe allergy Drug Formulation Polysorbate 80

Datatype

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0524527
UMLS CUI [2,3]
C0032601
10. patient may not be receiving any other investigational agents.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00887315

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
2. life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma
Item
3. histologically or cytologically confirmed diagnosis of nsclc
boolean
C0007131 (UMLS CUI [1])
TNM clinical staging | Distant metastasis | Malignant Pleural Effusion Absent | Malignant pericardial effusion Absent
Item
4. patients with ajcc stage iv cancer with distant metastases and without malignant pleural or pericardial effusion at diagnosis and before start of study
boolean
C3258246 (UMLS CUI [1])
C1269798 (UMLS CUI [2])
C0080032 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0220655 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hydrothorax | Pleural effusion Cytologic Negative | Pleural effusion Except Effusion pleural bloody | Patients Stable status
Item
1. patients with pleural effusion that is transudative, cytologically negative, and non-bloody are eligible as long as they are stable and do not impair the ability to define tumor volumes.
boolean
C0020312 (UMLS CUI [1])
C0032227 (UMLS CUI [2,1])
C0205471 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C0032227 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C0240784 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
Diagnostic thoracentesis Pleural effusion
Item
2. if a pleural effusion is too small for diagnostic thoracentesis, the patient will be eligible.
boolean
C0843886 (UMLS CUI [1,1])
C0032227 (UMLS CUI [1,2])
Disorder of lymph node Primary Suitable Therapeutic radiology procedure | Disorder of lymph node regional Suitable Therapeutic radiology procedure
Item
5. primary and regional nodal disease that is encompassable in a reasonable radiotherapy portal:
boolean
C0272394 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C3900053 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
C0272394 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C3900053 (UMLS CUI [2,3])
C1522449 (UMLS CUI [2,4])
Disease Site Quantity | Disease Amenable Therapeutic radiology procedure Imaging | Disease Amenable Therapeutic radiology procedure CT | Disease Amenable Therapeutic radiology procedure MRI | Disease Amenable Therapeutic radiology procedure Bone scan | Disease Amenable Therapeutic radiology procedure PET scan
Item
6. patients with 1-5 sites of disease and amenable to rt therapy as seen on standard imaging (ct, mri, bone scan, pet scan)
boolean
C0012634 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C0011923 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C3900053 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C0040405 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C3900053 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
C0024485 (UMLS CUI [4,4])
C0012634 (UMLS CUI [5,1])
C3900053 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
C0203668 (UMLS CUI [5,4])
C0012634 (UMLS CUI [6,1])
C3900053 (UMLS CUI [6,2])
C1522449 (UMLS CUI [6,3])
C0032743 (UMLS CUI [6,4])
Measurable Disease Linear
Item
7. unidimensionally measurable disease (based on recist) is desirable but not strictly required.
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Whole brain radiation therapy | Stereotactic Radiosurgery | Excision Followed by Whole brain radiation therapy
Item
8. patients with brain metastases are allowed as long as they meet all other inclusion criteria. brain metastases must be treated with whole brain radiotherapy and stereotactic radiosurgery or surgical resection followed by whole brain radiotherapy.
boolean
C0220650 (UMLS CUI [1])
C1520143 (UMLS CUI [2])
C3846112 (UMLS CUI [3])
C0728940 (UMLS CUI [4,1])
C0332283 (UMLS CUI [4,2])
C1520143 (UMLS CUI [4,3])
ECOG performance status
Item
9. ecog performance status <2
boolean
C1520224 (UMLS CUI [1])
Absence Prior radiation therapy Tumor site Involved
Item
10. no prior rt to currently involved tumor sites
boolean
C0332197 (UMLS CUI [1,1])
C0279134 (UMLS CUI [1,2])
C0475445 (UMLS CUI [1,3])
C1314939 (UMLS CUI [1,4])
Peripheral Neuropathy CTCAE Grades
Item
11. baseline peripheral neuropathy < grade 1
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Oxygen saturation measurement on room air
Item
12. room air saturation (sao2) > 90%
boolean
C0523807 (UMLS CUI [1,1])
C2709070 (UMLS CUI [1,2])
Organ function | Bone Marrow function
Item
13. patients must have normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Females & males of reproductive potential Contraceptive methods
Item
14. men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
15. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Gender | Minorities
Item
16. inclusion of women and minorities
boolean
C0079399 (UMLS CUI [1])
C0026192 (UMLS CUI [2])
Therapeutic radiology procedure Treatment Plan Complete
Item
17. rt: patient must have a completed treatment plan approved by the protocol review team
boolean
C1522449 (UMLS CUI [1,1])
C0599880 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
1. uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure (chf), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Pulmonary Dysfunction | Cardiomyopathy | Congestive heart failure | Coronary heart disease Physician Decision
Item
2. patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant chf are excluded. the exclusion of patients with active coronary heart disease will be at the discretion of the attending physician.
boolean
C1709770 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0010068 (UMLS CUI [4,1])
C1709536 (UMLS CUI [4,2])
Atelectasis | Gross tumor volume CT Difficult
Item
3. patients with significant atelectasis such that ct definition of the gross tumor volume (gtv) is difficult to determine.
boolean
C0004144 (UMLS CUI [1])
C0475645 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Lung Portion Free of Tumor
Item
4. < 1000 cc of tumor free lung.
boolean
C0024109 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0027651 (UMLS CUI [1,4])
Tumor Volume | Tumor Location | Requirement Lung volume PTV Percentage
Item
5. tumor volume and location which requires a lung volume-ptv >40% to receive >20 gy (v20 <40%).
boolean
C0475276 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0231953 (UMLS CUI [3,2])
C0454199 (UMLS CUI [3,3])
C0439165 (UMLS CUI [3,4])
Exudative pleural effusion | Effusion pleural bloody | Pleural Effusion, Malignant
Item
6. patients with exudative, bloody, or cytologically malignant effusions are not eligible.
boolean
C3887491 (UMLS CUI [1])
C0240784 (UMLS CUI [2])
C0080032 (UMLS CUI [3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
7. pregnancy or breast feeding (women of child-bearing potential are eligible, but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Communicable Disease Uncontrolled
Item
8. patients must have no uncontrolled active infection other than that not curable without treatment of their cancer.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Severe allergy Docetaxel | Severe allergy Drug Formulation Polysorbate 80
Item
9. patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
boolean
C2945656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0524527 (UMLS CUI [2,2])
C0032601 (UMLS CUI [2,3])
Investigational New Drugs
Item
10. patient may not be receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
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