ID

27242

Description

Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy; ODM derived from: https://clinicaltrials.gov/show/NCT01185132

Link

https://clinicaltrials.gov/show/NCT01185132

Keywords

Versions (1)
  1. 11/4/17 11/4/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01185132

English

Eligibility Breast Cancer NCT01185132

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed disease (ajc classification): tis, t1, t2 (≤ 3.0 cm), n0, m0.
Description

Disease TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
Description

Disease Multifocal Microscopic | Disease Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205292
UMLS CUI [1,3]
C0205288
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1301886
negative surgical margins ( ≥ 0.2 cm) after final surgery.
Description

Negative Surgical Margins Post Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1709157
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0543467
subjects with infiltrating lobular histologies or high nuclear grade dcis will be required to have breast mri scanning as part of the initial staging to verify localized disease.
Description

Histology Lobular Infiltrating | DCIS Nuclear grade High | Magnetic resonance imaging of breast Patient need for | Localized disease TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0344441
UMLS CUI [1,2]
C0205417
UMLS CUI [1,3]
C0332448
UMLS CUI [2,1]
C0007124
UMLS CUI [2,2]
C1518435
UMLS CUI [2,3]
C0205250
UMLS CUI [3,1]
C0344104
UMLS CUI [3,2]
C0686904
UMLS CUI [4,1]
C0277565
UMLS CUI [4,2]
C0474926
subjects with dcis will be included in the study only if they had an mri prior to lumpectomy.
Description

DCIS | MRI Before Lumpectomy

Data type

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0024885
findings on mri scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease.
Description

Distant metastasis Suspected MRI Scan | Ultrasonography Patient need for | Biopsy Patient need for | Exclusion Disease Multifocal | Exclusion Disease Multicentric

Data type

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0750491
UMLS CUI [1,3]
C0917711
UMLS CUI [2,1]
C0041618
UMLS CUI [2,2]
C0686904
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0686904
UMLS CUI [4,1]
C2828389
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0205292
UMLS CUI [5,1]
C2828389
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0439743
subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.
Description

Calcifications Malignant Mammography | Mammography Repeat Post Operative Surgical Procedures | Excision Calcifications Malignant

Data type

boolean

Alias
UMLS CUI [1,1]
C0006660
UMLS CUI [1,2]
C0205282
UMLS CUI [1,3]
C0024671
UMLS CUI [2,1]
C0024671
UMLS CUI [2,2]
C0205341
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C0543467
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C0006660
UMLS CUI [3,3]
C0205282
willing to complete additional screening requirements and meet eligibility criteria as defined in protocol sec. 4.4.
Description

Protocol Compliance | Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C1516637
UMLS CUI [2,2]
C2348563
successful placement of fiducial markers for igrt requiring nonmigrating fiducials.
Description

Placement Fiducial Markers | Radiotherapy, Image-Guided

Data type

boolean

Alias
UMLS CUI [1,1]
C0441587
UMLS CUI [1,2]
C2826325
UMLS CUI [2]
C3179062
ptv to ipsilateral breast ratio (ibr) ≤ 25 %.
Description

PTV Breast Ipsilateral Ratio

Data type

boolean

Alias
UMLS CUI [1,1]
C0454199
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0441989
UMLS CUI [1,4]
C0456603
radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.
Description

Therapeutic radiology procedure Anticipated | Lumpectomy | Reexcision Surgical margins

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C3840775
UMLS CUI [2]
C0024885
UMLS CUI [3,1]
C0184913
UMLS CUI [3,2]
C0229985
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or breast-feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
have collagen-vascular disease.
Description

Collagen-vascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0262428
inadequate surgical margins ( < 0.2 cm) after final surgery.
Description

Surgical margins Inadequate Post Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0229985
UMLS CUI [1,2]
C0205412
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0543467
subjects with persistent malignant/suspicious micro-calcifications.
Description

Microcalcifications Malignant persistent | Microcalcifications Suspicious persistent

Data type

boolean

Alias
UMLS CUI [1,1]
C0521174
UMLS CUI [1,2]
C0205282
UMLS CUI [1,3]
C0205322
UMLS CUI [2,1]
C0521174
UMLS CUI [2,2]
C0750493
UMLS CUI [2,3]
C0205322
gross multifocal disease and microscopic disease greater than 3.0 cm.
Description

Disease Multifocal Gross | Disease Microscopic Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205292
UMLS CUI [1,3]
C0439806
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205288
UMLS CUI [2,3]
C1301886
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Similar models

Eligibility Breast Cancer NCT01185132

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Disease TNM Breast tumor staging
Item
histologically confirmed disease (ajc classification): tis, t1, t2 (≤ 3.0 cm), n0, m0.
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Disease Multifocal Microscopic | Disease Diameter
Item
microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
boolean
C0012634 (UMLS CUI [1,1])
C0205292 (UMLS CUI [1,2])
C0205288 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
Negative Surgical Margins Post Operative Surgical Procedures
Item
negative surgical margins ( ≥ 0.2 cm) after final surgery.
boolean
C1709157 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Histology Lobular Infiltrating | DCIS Nuclear grade High | Magnetic resonance imaging of breast Patient need for | Localized disease TNM Breast tumor staging
Item
subjects with infiltrating lobular histologies or high nuclear grade dcis will be required to have breast mri scanning as part of the initial staging to verify localized disease.
boolean
C0344441 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0332448 (UMLS CUI [1,3])
C0007124 (UMLS CUI [2,1])
C1518435 (UMLS CUI [2,2])
C0205250 (UMLS CUI [2,3])
C0344104 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C0277565 (UMLS CUI [4,1])
C0474926 (UMLS CUI [4,2])
DCIS | MRI Before Lumpectomy
Item
subjects with dcis will be included in the study only if they had an mri prior to lumpectomy.
boolean
C0007124 (UMLS CUI [1])
C0024485 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0024885 (UMLS CUI [2,3])
Distant metastasis Suspected MRI Scan | Ultrasonography Patient need for | Biopsy Patient need for | Exclusion Disease Multifocal | Exclusion Disease Multicentric
Item
findings on mri scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease.
boolean
C1269798 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0917711 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C2828389 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0205292 (UMLS CUI [4,3])
C2828389 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0439743 (UMLS CUI [5,3])
Calcifications Malignant Mammography | Mammography Repeat Post Operative Surgical Procedures | Excision Calcifications Malignant
Item
subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.
boolean
C0006660 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,3])
C0024671 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0543467 (UMLS CUI [2,4])
C0728940 (UMLS CUI [3,1])
C0006660 (UMLS CUI [3,2])
C0205282 (UMLS CUI [3,3])
Protocol Compliance | Clinical Trial Eligibility Criteria Study Protocol
Item
willing to complete additional screening requirements and meet eligibility criteria as defined in protocol sec. 4.4.
boolean
C0525058 (UMLS CUI [1])
C1516637 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Placement Fiducial Markers | Radiotherapy, Image-Guided
Item
successful placement of fiducial markers for igrt requiring nonmigrating fiducials.
boolean
C0441587 (UMLS CUI [1,1])
C2826325 (UMLS CUI [1,2])
C3179062 (UMLS CUI [2])
PTV Breast Ipsilateral Ratio
Item
ptv to ipsilateral breast ratio (ibr) ≤ 25 %.
boolean
C0454199 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0456603 (UMLS CUI [1,4])
Therapeutic radiology procedure Anticipated | Lumpectomy | Reexcision Surgical margins
Item
radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.
boolean
C1522449 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0024885 (UMLS CUI [2])
C0184913 (UMLS CUI [3,1])
C0229985 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Collagen-vascular disease
Item
have collagen-vascular disease.
boolean
C0262428 (UMLS CUI [1])
Surgical margins Inadequate Post Operative Surgical Procedures
Item
inadequate surgical margins ( < 0.2 cm) after final surgery.
boolean
C0229985 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
Microcalcifications Malignant persistent | Microcalcifications Suspicious persistent
Item
subjects with persistent malignant/suspicious micro-calcifications.
boolean
C0521174 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
C0521174 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C0205322 (UMLS CUI [2,3])
Disease Multifocal Gross | Disease Microscopic Diameter
Item
gross multifocal disease and microscopic disease greater than 3.0 cm.
boolean
C0012634 (UMLS CUI [1,1])
C0205292 (UMLS CUI [1,2])
C0439806 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205288 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
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