ID

37808

Beskrivning

Brain Mets - Capecitabine Plus Sunitinib and WBRT; ODM derived from: https://clinicaltrials.gov/show/NCT00570908

Länk

https://clinicaltrials.gov/show/NCT00570908

Nyckelord

Versioner (1)
  1. 2019-08-25 2019-08-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00570908

Engelsk

Eligibility Breast Cancer NCT00570908

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be age 18 or older. histological or cytologically confirmed invasive breast cancer, with stage iv disease.
Beskrivning

Age | Invasive carcinoma of breast | Disease TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0853879
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0474926
evidence of radiographically measurable cns metastases (greater than or equal to 10mm on t1-weighted gadolinium-enhanced mri) within 2 weeks prior to starting treatment. patients without known extra-cns disease are eligible.
Beskrivning

CNS metastases Measurable Radiography | CNS metastases Size T1 MRI gadolinium-enhanced | Absence Disease Except CNS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C0034571
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C2697938
UMLS CUI [2,4]
C0855566
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332300
UMLS CUI [3,4]
C3714787
must have metastases in the brain. patients with concurrent leptomeningeal carcinomatosis are eligible for the study. local radiation to sites of meningeal involvement in the spine is allowed.
Beskrivning

Metastatic malignant neoplasm to brain | Meningeal Carcinomatosis | Therapeutic radiology procedure Spine Involvement meningeal

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0220654
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0037949
UMLS CUI [3,3]
C1314939
UMLS CUI [3,4]
C0521400
no prior whole brain radiation. patients who had previous stereotactic brain irradiation are eligible, provided they have new measurable brain lesions (which has not been radiated previously) and will receive wbrt at 30gy over 10 fractions.
Beskrivning

Whole brain radiation therapy Previous Absent | Radiotherapy to brain Stereotactic | Lesion of brain New Measurable | Whole brain radiation therapy Expected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1520143
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0948319
UMLS CUI [2,2]
C0729296
UMLS CUI [3,1]
C0221505
UMLS CUI [3,2]
C0205314
UMLS CUI [3,3]
C1513040
UMLS CUI [4,1]
C1520143
UMLS CUI [4,2]
C1517001
may undergo surgical resection of cns metastases if clinically indicated, but must have remaining measurable disease in the brain after surgery.
Beskrivning

Excision CNS metastases | Measurable Disease Remaining Brain | Status post Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0686377
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1527428
UMLS CUI [2,3]
C0006104
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0543467
no prior treatment with capecitabine in the adjuvant or metastatic settings. patients may have completed 5-fluorouracil based treatment in the adjuvant setting or metastatic setting more than one year prior.
Beskrivning

Capecitabine Adjuvant therapy Absent | Capecitabine Absent Neoplasm Metastasis | Fluorouracil Adjuvant therapy Completed | Fluorouracil Neoplasm Metastasis Treatment completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0671970
UMLS CUI [1,2]
C0677850
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0671970
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0027627
UMLS CUI [3,1]
C0016360
UMLS CUI [3,2]
C0677850
UMLS CUI [3,3]
C0205197
UMLS CUI [4,1]
C0016360
UMLS CUI [4,2]
C0027627
UMLS CUI [4,3]
C0580352
patients who had previous trastuzumab therapy will be eligible but treatment will be discontinued prior to enrollment.
Beskrivning

trastuzumab | Treatment To be stopped

Datatyp

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1272691
cardiac ejection fraction within institutional range of normal as measure by echocardiogram or muga scans at baseline.
Beskrivning

Cardiac ejection fraction Normal Range Echocardiography | Cardiac ejection fraction Normal Range MUGA scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0086715
UMLS CUI [1,3]
C0013516
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0086715
UMLS CUI [2,3]
C0521317
hematological adequacy hepatic adequacy renal adequacy must have recovered from toxicity of prior chemotherapy with laboratory values as specified above. concurrent treatment with bisphosphonates is permitted. performance status of ecog 0-1.
Beskrivning

Hematologic function | Liver function | Renal function | Toxicity Due to Prior Chemotherapy | Patient recovered | Diphosphonates | ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C1514457
UMLS CUI [5]
C1115804
UMLS CUI [6]
C0012544
UMLS CUI [7]
C1520224
life expectancy of at least 12 weeks. at least 3 weeks since major surgical procedures. able to swallow and retain oral medication.
Beskrivning

Life Expectancy | Major surgery | Able to swallow Oral medication | Ability Retain Oral medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C0679637
UMLS CUI [3,1]
C2712086
UMLS CUI [3,2]
C0175795
UMLS CUI [4,1]
C0085732
UMLS CUI [4,2]
C0333118
UMLS CUI [4,3]
C0175795
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast feeding. known allergy to capecitabine or 5-fluorouracil. known to have dihydropyrimidine dehydrogenase (dpd) deficiency.
Beskrivning

Pregnancy | Breast Feeding | Hypersensitivity Capecitabine | Fluorouracil allergy | Dihydropyrimidine Dehydrogenase Deficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0671970
UMLS CUI [4]
C0570698
UMLS CUI [5]
C1959620
patients who have leptomeningeal carcinomatosis as the only site of cns metastases.
Beskrivning

Meningeal Carcinomatosis | Site CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0220654
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0686377
patients taking concomitant medications which are cyp3a4 inhibitors or inducers.
Beskrivning

CYP3A4 Inhibitors | CYP3A4 Inducers

Datatyp

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C3850041
patients who will receive intrathecal chemotherapy for leptomeningeal disease. patients with psychiatric or addictive disorders that would adversely effect compliance with oral medication.
Beskrivning

Intrathecal chemotherapy Leptomeningeal Neoplasms | Mental disorders Adverse effects Compliance Oral medication | Addictive Behavior Adverse effects Compliance Oral medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1517560
UMLS CUI [1,2]
C0751297
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0879626
UMLS CUI [2,3]
C1321605
UMLS CUI [2,4]
C0175795
UMLS CUI [3,1]
C0085281
UMLS CUI [3,2]
C0879626
UMLS CUI [3,3]
C1321605
UMLS CUI [3,4]
C0175795
life expectancy less than 3 months. symptomatic lymphangitic spread to lung. malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
Beskrivning

Life Expectancy | Lymphangitic spread Symptomatic Lung | Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Gastrectomy | Small intestine excision

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C3697833
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0024109
UMLS CUI [3]
C0024523
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0516983
UMLS CUI [5]
C0017118
UMLS CUI [6]
C0192601
history of immediate or delayed hypersensitivity reaction to gadolinium contrast agents, or other contraindication or gadolinium contrast.
Beskrivning

Immediate hypersensitivity Gadolinium-based Contrast Agent | Delayed Hypersensitivity Gadolinium-based Contrast Agent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020523
UMLS CUI [1,2]
C3249258
UMLS CUI [2,1]
C0020522
UMLS CUI [2,2]
C3249258
other known contraindication to mri, such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel,
Beskrivning

Medical contraindication MRI | Artificial cardiac pacemaker | Implantation of internal cardiac defibrillator | Brain Aneurysm clip | Cochlear Implants | Ocular Foreign Body | Shrapnel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3]
C1273352
UMLS CUI [4,1]
C0006104
UMLS CUI [4,2]
C0179977
UMLS CUI [5]
C0009199
UMLS CUI [6]
C3898107
UMLS CUI [7]
C0522670
1vascular disease within 12 months prior to enrollment uncontrolled infection history of other malignancy, except for curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. subjects with other malignancies who have been disease-free for at least 5 years are eligible
Beskrivning

Vascular Disease | Communicable Disease Uncontrolled | Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Disease Free Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C0042373
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C1707251
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C0553723
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1273390
UMLS CUI [6,3]
C0851140
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0012634
UMLS CUI [7,3]
C0332296
UMLS CUI [7,4]
C0449238
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Similar models

Eligibility Breast Cancer NCT00570908

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Invasive carcinoma of breast | Disease TNM Breast tumor staging
Item
patients must be age 18 or older. histological or cytologically confirmed invasive breast cancer, with stage iv disease.
boolean
C0001779 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
CNS metastases Measurable Radiography | CNS metastases Size T1 MRI gadolinium-enhanced | Absence Disease Except CNS
Item
evidence of radiographically measurable cns metastases (greater than or equal to 10mm on t1-weighted gadolinium-enhanced mri) within 2 weeks prior to starting treatment. patients without known extra-cns disease are eligible.
boolean
C0686377 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C0686377 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C2697938 (UMLS CUI [2,3])
C0855566 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332300 (UMLS CUI [3,3])
C3714787 (UMLS CUI [3,4])
Metastatic malignant neoplasm to brain | Meningeal Carcinomatosis | Therapeutic radiology procedure Spine Involvement meningeal
Item
must have metastases in the brain. patients with concurrent leptomeningeal carcinomatosis are eligible for the study. local radiation to sites of meningeal involvement in the spine is allowed.
boolean
C0220650 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0037949 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0521400 (UMLS CUI [3,4])
Whole brain radiation therapy Previous Absent | Radiotherapy to brain Stereotactic | Lesion of brain New Measurable | Whole brain radiation therapy Expected
Item
no prior whole brain radiation. patients who had previous stereotactic brain irradiation are eligible, provided they have new measurable brain lesions (which has not been radiated previously) and will receive wbrt at 30gy over 10 fractions.
boolean
C1520143 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0948319 (UMLS CUI [2,1])
C0729296 (UMLS CUI [2,2])
C0221505 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C1513040 (UMLS CUI [3,3])
C1520143 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
Excision CNS metastases | Measurable Disease Remaining Brain | Status post Operative Surgical Procedures
Item
may undergo surgical resection of cns metastases if clinically indicated, but must have remaining measurable disease in the brain after surgery.
boolean
C0728940 (UMLS CUI [1,1])
C0686377 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1527428 (UMLS CUI [2,2])
C0006104 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
Capecitabine Adjuvant therapy Absent | Capecitabine Absent Neoplasm Metastasis | Fluorouracil Adjuvant therapy Completed | Fluorouracil Neoplasm Metastasis Treatment completed
Item
no prior treatment with capecitabine in the adjuvant or metastatic settings. patients may have completed 5-fluorouracil based treatment in the adjuvant setting or metastatic setting more than one year prior.
boolean
C0671970 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0671970 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0016360 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C0016360 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C0580352 (UMLS CUI [4,3])
trastuzumab | Treatment To be stopped
Item
patients who had previous trastuzumab therapy will be eligible but treatment will be discontinued prior to enrollment.
boolean
C0728747 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Cardiac ejection fraction Normal Range Echocardiography | Cardiac ejection fraction Normal Range MUGA scan
Item
cardiac ejection fraction within institutional range of normal as measure by echocardiogram or muga scans at baseline.
boolean
C0232174 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
C0232174 (UMLS CUI [2,1])
C0086715 (UMLS CUI [2,2])
C0521317 (UMLS CUI [2,3])
Hematologic function | Liver function | Renal function | Toxicity Due to Prior Chemotherapy | Patient recovered | Diphosphonates | ECOG performance status
Item
hematological adequacy hepatic adequacy renal adequacy must have recovered from toxicity of prior chemotherapy with laboratory values as specified above. concurrent treatment with bisphosphonates is permitted. performance status of ecog 0-1.
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0600688 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C1514457 (UMLS CUI [4,3])
C1115804 (UMLS CUI [5])
C0012544 (UMLS CUI [6])
C1520224 (UMLS CUI [7])
Life Expectancy | Major surgery | Able to swallow Oral medication | Ability Retain Oral medication
Item
life expectancy of at least 12 weeks. at least 3 weeks since major surgical procedures. able to swallow and retain oral medication.
boolean
C0023671 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C2712086 (UMLS CUI [3,1])
C0175795 (UMLS CUI [3,2])
C0085732 (UMLS CUI [4,1])
C0333118 (UMLS CUI [4,2])
C0175795 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Hypersensitivity Capecitabine | Fluorouracil allergy | Dihydropyrimidine Dehydrogenase Deficiency
Item
pregnant or breast feeding. known allergy to capecitabine or 5-fluorouracil. known to have dihydropyrimidine dehydrogenase (dpd) deficiency.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0671970 (UMLS CUI [3,2])
C0570698 (UMLS CUI [4])
C1959620 (UMLS CUI [5])
Meningeal Carcinomatosis | Site CNS metastases
Item
patients who have leptomeningeal carcinomatosis as the only site of cns metastases.
boolean
C0220654 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
CYP3A4 Inhibitors | CYP3A4 Inducers
Item
patients taking concomitant medications which are cyp3a4 inhibitors or inducers.
boolean
C3850053 (UMLS CUI [1])
C3850041 (UMLS CUI [2])
Intrathecal chemotherapy Leptomeningeal Neoplasms | Mental disorders Adverse effects Compliance Oral medication | Addictive Behavior Adverse effects Compliance Oral medication
Item
patients who will receive intrathecal chemotherapy for leptomeningeal disease. patients with psychiatric or addictive disorders that would adversely effect compliance with oral medication.
boolean
C1517560 (UMLS CUI [1,1])
C0751297 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0175795 (UMLS CUI [2,4])
C0085281 (UMLS CUI [3,1])
C0879626 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
C0175795 (UMLS CUI [3,4])
Life Expectancy | Lymphangitic spread Symptomatic Lung | Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Gastrectomy | Small intestine excision
Item
life expectancy less than 3 months. symptomatic lymphangitic spread to lung. malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
boolean
C0023671 (UMLS CUI [1])
C3697833 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0024109 (UMLS CUI [2,3])
C0024523 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0516983 (UMLS CUI [4,3])
C0017118 (UMLS CUI [5])
C0192601 (UMLS CUI [6])
Immediate hypersensitivity Gadolinium-based Contrast Agent | Delayed Hypersensitivity Gadolinium-based Contrast Agent
Item
history of immediate or delayed hypersensitivity reaction to gadolinium contrast agents, or other contraindication or gadolinium contrast.
boolean
C0020523 (UMLS CUI [1,1])
C3249258 (UMLS CUI [1,2])
C0020522 (UMLS CUI [2,1])
C3249258 (UMLS CUI [2,2])
Medical contraindication MRI | Artificial cardiac pacemaker | Implantation of internal cardiac defibrillator | Brain Aneurysm clip | Cochlear Implants | Ocular Foreign Body | Shrapnel
Item
other known contraindication to mri, such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel,
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C1273352 (UMLS CUI [3])
C0006104 (UMLS CUI [4,1])
C0179977 (UMLS CUI [4,2])
C0009199 (UMLS CUI [5])
C3898107 (UMLS CUI [6])
C0522670 (UMLS CUI [7])
Vascular Disease | Communicable Disease Uncontrolled | Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Disease Free Duration
Item
1vascular disease within 12 months prior to enrollment uncontrolled infection history of other malignancy, except for curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. subjects with other malignancies who have been disease-free for at least 5 years are eligible
boolean
C0042373 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1707251 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0007117 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0553723 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C0851140 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
C0332296 (UMLS CUI [7,3])
C0449238 (UMLS CUI [7,4])
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