ID

38034

Beschreibung

Accelerated Hypofractionated Radiotherapy (AHF-RT) for the Treatment of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01278212

Link

https://clinicaltrials.gov/show/NCT01278212

Stichworte

Versionen (1)
  1. 10.09.19 10.09.19 -
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See clinicaltrials.gov

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10. September 2019

DOI

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Eligibility Breast Cancer NCT01278212

Englisch

Eligibility Breast Cancer NCT01278212

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
only women who satisfy all of the following conditions will be eligible for this study.
Beschreibung

Gender | Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
1. must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. must be at least 21 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. must have stage 0, i, or ii breast cancer
Beschreibung

Breast Carcinoma TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
4. on histological examination, the tumor must be ductal carcinoma in situ (dcis) or invasive adenocarcinoma of the breast.
Beschreibung

DCIS | Breast adenocarcinoma Invasive

Datentyp

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2,1]
C0858252
UMLS CUI [2,2]
C0205281
5. surgical treatment of the breast must have been breast conserving surgery (bcs). the margins of the resected specimen must be histologically free of tumor (including dcis component). reexcision of surgical margins is permitted.
Beschreibung

Breast-Conserving Surgery | Negative Surgical Margin Specimen Resected | Specimen Free of DCIS Component | Reexcision Surgical margins allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C0917927
UMLS CUI [2,1]
C1709157
UMLS CUI [2,2]
C0370003
UMLS CUI [2,3]
C1521996
UMLS CUI [3,1]
C0370003
UMLS CUI [3,2]
C0332296
UMLS CUI [3,3]
C0007124
UMLS CUI [3,4]
C1705248
UMLS CUI [4,1]
C0184913
UMLS CUI [4,2]
C0229985
UMLS CUI [4,3]
C0683607
6. gross disease may be unifocal or multifocal with pathologic (invasive and/or dcis) tumor size excised with negative margins.
Beschreibung

Disease Gross Unifocal | Disease Gross Multifocal | Invasive cancer | DCIS | Tumor size | Excision of neoplasm Negative Surgical Margin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439806
UMLS CUI [1,3]
C0443337
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0439806
UMLS CUI [2,3]
C0205292
UMLS CUI [3]
C0677898
UMLS CUI [4]
C0007124
UMLS CUI [5]
C0475440
UMLS CUI [6,1]
C1299802
UMLS CUI [6,2]
C1709157
7. patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). axillary staging is not required for patients with dcis.
Beschreibung

Invasive carcinoma of breast | Requirement Axillary lymph nodes TNM clinical staging | Sentinel Lymph Node Biopsy | Sentinel Lymph Node Negative | Excision of axillary lymph nodes | Axillary lymph nodes sampling | Axillary lymph nodes Quantity | Sentinel Lymph Node Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0729594
UMLS CUI [2,3]
C3258246
UMLS CUI [3]
C0796693
UMLS CUI [4,1]
C1522495
UMLS CUI [4,2]
C1513916
UMLS CUI [5]
C0193867
UMLS CUI [6]
C0398420
UMLS CUI [7,1]
C0729594
UMLS CUI [7,2]
C1265611
UMLS CUI [8,1]
C1522495
UMLS CUI [8,2]
C1514241
8. must begin adjuvant therapy (chemotherapy or radiotherapy) within 9 weeks following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure)
Beschreibung

Chemotherapy, Adjuvant | Radiotherapy, Adjuvant | Status post Operative Surgical Procedure Breast Carcinoma | Segmental Mastectomy | Reexcision Surgical margins | Axillary lymph nodes TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2]
C0242939
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0678222
UMLS CUI [4]
C0024885
UMLS CUI [5,1]
C0184913
UMLS CUI [5,2]
C0229985
UMLS CUI [6,1]
C0729594
UMLS CUI [6,2]
C3258246
9. patients must have all usual and customary hormone receptor (er/pr) and estrogen receptor (er) analysis performed on the primary tumor prior to enrollment. patients with invasive disease must have her2 receptor status determined (positive or negative) with immuno-histochemistry (ihc) and/or fluorescent in-situ hybridization (fish).
Beschreibung

Hormone Receptor Analysis Primary tumor | Estrogen receptor assay Primary tumor | Progesterone receptor assay Primary tumor | Invasive cancer | HER2 Status Immunohistochemistry | HER2 Status FISH

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0936012
UMLS CUI [1,3]
C0677930
UMLS CUI [2,1]
C0201553
UMLS CUI [2,2]
C0677930
UMLS CUI [3,1]
C0373717
UMLS CUI [3,2]
C0677930
UMLS CUI [4]
C0677898
UMLS CUI [5,1]
C1512413
UMLS CUI [5,2]
C0021044
UMLS CUI [6,1]
C1512413
UMLS CUI [6,2]
C0162789
10. at the time of study enrollment, patients must have had a history & physical exam within 4 months and a bilateral mammogram within 6 months.
Beschreibung

Medical History | Physical Examination | Bilateral mammography

Datentyp

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0203027
11. patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to enrollment and are deemed by their physician to be at low risk for recurrence. patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
Beschreibung

Malignant Neoplasms Disease Free Duration | Exception Breast Carcinoma | Patients Low Risk Recurrence | Carcinoma in situ of uterine cervix Treated | Colon Carcinoma In situ Treated | Malignant melanoma in situ Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0332296
UMLS CUI [1,4]
C0449238
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C3538919
UMLS CUI [3,3]
C0034897
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0699790
UMLS CUI [5,2]
C0444498
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C0854696
UMLS CUI [6,2]
C1522326
UMLS CUI [7,1]
C0007117
UMLS CUI [7,2]
C1522326
UMLS CUI [8,1]
C0553723
UMLS CUI [8,2]
C1522326
12. patients must live in a county that is designated as appalachian and/or rural by kentucky cancer registry criteria (see list below) and/or must hold their primary residence at least 10 miles from the nearest radiation facility. patients who do not fit these criteria may still be considered eligible if they are determined to suffer significant financial and/or transportation hardship during a typical course of cf-rt or hf-rt (in the judgment of any of their treating physicians). patients who live outside the commonwealth of kentucky are eligible if they fit any of these aforementioned conditions.
Beschreibung

Residence Appalachian Region | Residence Rural area | Residence Nearby Radiotherapy facility | Patients Hardship | Patients Transportation hardship | Radiotherapy Conventional Fractionated | Hypofractionated radiation therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0003609
UMLS CUI [2,1]
C0237096
UMLS CUI [2,2]
C0178837
UMLS CUI [3,1]
C0237096
UMLS CUI [3,2]
C1706276
UMLS CUI [3,3]
C0337999
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0032854
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C0040756
UMLS CUI [5,3]
C0032854
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C0439858
UMLS CUI [6,3]
C1979893
UMLS CUI [7]
C1831786
appalachian counties in ky include: adair, bath, bell, boyd, breathitt, carter, casey, clark, clay, clinton, cumberland, edmonson, elliott, estill, fleming, floyd, garrard, green, greenup, harlan, hart, jackson, johnson, knott, knox, laurel, lawrence, lee, leslie, letcher, lewis, lincoln, madison, magoffin, martin, mccreary, menifee, metcalfe, monroe, montgomery, morgan, nicholas, owsley, perry, pike, powell, pulaski, robertson, rockcastle, rowan, russell, wayne, whitley, wolfe.
Beschreibung

Appalachian Region Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003609
UMLS CUI [1,2]
C0205369
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
men are not eligible for this study. women with one or more of the following conditions are ineligible for this study.
Beschreibung

Gender | Gender Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C1550543
1. t3, stage iii, or stage iv breast cancer
Beschreibung

Breast Carcinoma TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
2. more than 3 histologically positive axillary nodes
Beschreibung

Axillary lymph nodes Positive Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C1265611
3. axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
Beschreibung

Axillary lymph nodes | Extension Extracapsular Microscopic | Extension Extracapsular Macroscopic

Datentyp

boolean

Alias
UMLS CUI [1]
C0729594
UMLS CUI [2,1]
C0231448
UMLS CUI [2,2]
C1517049
UMLS CUI [2,3]
C0205288
UMLS CUI [3,1]
C0231448
UMLS CUI [3,2]
C1517049
UMLS CUI [3,3]
C0439806
4. one or more positive non-axillary sentinel node(s) (note that intramammary nodes are staged as axillary nodes.)
Beschreibung

Sentinel Lymph Nodes Positive Quantity | Exception Sentinel Lymph Nodes Axillary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1522495
UMLS CUI [2,3]
C0004454
5. palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
Beschreibung

Axillary lymph nodes Ipsilateral Suspicious Palpable | Axillary lymph nodes Contralateral Suspicious Palpable | Supraclavicular lymph nodes Suspicious Palpable | Infraclavicular lymph nodes Suspicious Palpable | Internal mammary lymph nodes Suspicious Palpable | Axillary lymph nodes Ipsilateral Suspicious Radiography | Axillary lymph nodes Contralateral Suspicious Radiography | Supraclavicular lymph nodes Suspicious Radiography | Infraclavicular lymph nodes Suspicious Radiography | Internal mammary lymph nodes Suspicious Radiography | Exception Negative Lymph Node

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C0441989
UMLS CUI [1,3]
C0750493
UMLS CUI [1,4]
C0522499
UMLS CUI [2,1]
C0729594
UMLS CUI [2,2]
C0441988
UMLS CUI [2,3]
C0750493
UMLS CUI [2,4]
C0522499
UMLS CUI [3,1]
C0229730
UMLS CUI [3,2]
C0750493
UMLS CUI [3,3]
C0522499
UMLS CUI [4,1]
C0229743
UMLS CUI [4,2]
C0750493
UMLS CUI [4,3]
C0522499
UMLS CUI [5,1]
C0542554
UMLS CUI [5,2]
C0750493
UMLS CUI [5,3]
C0522499
UMLS CUI [6,1]
C0729594
UMLS CUI [6,2]
C0441989
UMLS CUI [6,3]
C0750493
UMLS CUI [6,4]
C0034571
UMLS CUI [7,1]
C0729594
UMLS CUI [7,2]
C0441988
UMLS CUI [7,3]
C0750493
UMLS CUI [7,4]
C0034571
UMLS CUI [8,1]
C0229730
UMLS CUI [8,2]
C0750493
UMLS CUI [8,3]
C0034571
UMLS CUI [9,1]
C0229743
UMLS CUI [9,2]
C0750493
UMLS CUI [9,3]
C0034571
UMLS CUI [10,1]
C0542554
UMLS CUI [10,2]
C0750493
UMLS CUI [10,3]
C0034571
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0678034
6. suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
Beschreibung

Breast Microcalcification Ipsilateral Suspicious | Breast Microcalcification Contralateral Suspicious | Breast Density Ipsilateral Suspicious | Breast Density Contralateral Suspicious | Abnormality of the breast Ipsilateral Suspicious Palpable | Abnormality of the breast Contralateral Suspicious Palpable | Exception Abnormality Benign Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0520594
UMLS CUI [1,2]
C0441989
UMLS CUI [1,3]
C0750493
UMLS CUI [2,1]
C0520594
UMLS CUI [2,2]
C0441988
UMLS CUI [2,3]
C0750493
UMLS CUI [3,1]
C1659543
UMLS CUI [3,2]
C0441989
UMLS CUI [3,3]
C0750493
UMLS CUI [4,1]
C1659543
UMLS CUI [4,2]
C0441988
UMLS CUI [4,3]
C0750493
UMLS CUI [5,1]
C4025829
UMLS CUI [5,2]
C0441989
UMLS CUI [5,3]
C0750493
UMLS CUI [5,4]
C0522499
UMLS CUI [6,1]
C4025829
UMLS CUI [6,2]
C0441988
UMLS CUI [6,3]
C0750493
UMLS CUI [6,4]
C0522499
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1704258
UMLS CUI [7,3]
C0205183
UMLS CUI [7,4]
C0005558
7. non-epithelial breast malignancies such as sarcoma or lymphoma
Beschreibung

Breast Carcinoma not involving Epithelium | Sarcoma | Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205429
UMLS CUI [1,3]
C0014609
UMLS CUI [2]
C1261473
UMLS CUI [3]
C0024299
8. proven multicentric carcinoma (invasive cancer or dcis) in more than one quadrant or separated by 4 or more centimeters
Beschreibung

Multicentric Breast Carcinoma Quadrant Quantity | Invasive cancer | DCIS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986664
UMLS CUI [1,2]
C1631280
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0677898
UMLS CUI [3]
C0007124
9. paget's disease of the nipple
Beschreibung

Paget's Disease of the Nipple

Datentyp

boolean

Alias
UMLS CUI [1]
C1704323
10. synchronous bilateral invasive or non-invasive breast cancer
Beschreibung

Invasive carcinoma of breast Bilateral Synchronous | Breast Carcinoma Except Invasive carcinoma of breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0238767
UMLS CUI [1,3]
C0439580
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0853879
11. history of invasive breast cancer or dcis (patients with a history of lobular carcinoma in situ (lcis) treated by surgery alone are eligible.)
Beschreibung

Medical History Invasive cancer | Medical History DCIS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0677898
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0007124
12. surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation (if surgical margins are rendered free of disease by reexcision, the patient is eligible.)
Beschreibung

Surgical margins Microscopy Assessment Unsuccessful | Surgical margins Positive Evaluation Pathologic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0229985
UMLS CUI [1,2]
C0026018
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C1272705
UMLS CUI [2,1]
C0229985
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C1521733
13. treatment plan that includes regional nodal irradiation
Beschreibung

Radiotherapy to lymph nodes regional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1504399
UMLS CUI [1,2]
C0205147
14. current therapy with any hormonal agents such as raloxifene (evista®), tamoxifen, or other selective estrogen receptor modulators (serms), either for osteoporosis or breast cancer prevention (patients are eligible only if these medications are discontinued prior to enrollment.)
Beschreibung

Antineoplastic Agents, Hormonal | Raloxifene | Evista | Tamoxifen | Selective Estrogen Receptor Modulators | Prophylactic treatment Osteoporosis | Prophylactic treatment Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0282559
UMLS CUI [2]
C0244404
UMLS CUI [3]
C0720318
UMLS CUI [4]
C0039286
UMLS CUI [5]
C0732611
UMLS CUI [6,1]
C0199176
UMLS CUI [6,2]
C0029456
UMLS CUI [7,1]
C0199176
UMLS CUI [7,2]
C0678222
15. cosmetic breast implants (patients who have had implants removed are eligible.)
Beschreibung

Breast implants cosmetic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0179412
UMLS CUI [1,2]
C0010164
16. prior breast or thoracic rt for any condition
Beschreibung

Radiotherapy to breast | Radiotherapy to thorax

Datentyp

boolean

Alias
UMLS CUI [1]
C0948310
UMLS CUI [2]
C4038705
17. collagen vascular disease, specifically dermatomyositis with a cpk level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma
Beschreibung

Collagen-vascular disease | Dermatomyositis | Elevated creatine kinase | Exanthema | Lupus Erythematosus, Systemic | Scleroderma

Datentyp

boolean

Alias
UMLS CUI [1]
C0262428
UMLS CUI [2]
C0011633
UMLS CUI [3]
C0151576
UMLS CUI [4]
C0015230
UMLS CUI [5]
C0024141
UMLS CUI [6]
C0011644
18. pregnancy or lactation at the time of proposed randomization. women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Exception Hormonal contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2985296
19. psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
Beschreibung

Mental disorders Exclude Protocol Compliance | Addictive Behavior Excludes Protocol Compliance | Condition Excludes Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0525058
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Ähnliche Modelle

Eligibility Breast Cancer NCT01278212

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Criteria Fulfill
Item
only women who satisfy all of the following conditions will be eligible for this study.
boolean
C0079399 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Informed Consent
Item
1. must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. must be at least 21 years old
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
3. must have stage 0, i, or ii breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
DCIS | Breast adenocarcinoma Invasive
Item
4. on histological examination, the tumor must be ductal carcinoma in situ (dcis) or invasive adenocarcinoma of the breast.
boolean
C0007124 (UMLS CUI [1])
C0858252 (UMLS CUI [2,1])
C0205281 (UMLS CUI [2,2])
Breast-Conserving Surgery | Negative Surgical Margin Specimen Resected | Specimen Free of DCIS Component | Reexcision Surgical margins allowed
Item
5. surgical treatment of the breast must have been breast conserving surgery (bcs). the margins of the resected specimen must be histologically free of tumor (including dcis component). reexcision of surgical margins is permitted.
boolean
C0917927 (UMLS CUI [1])
C1709157 (UMLS CUI [2,1])
C0370003 (UMLS CUI [2,2])
C1521996 (UMLS CUI [2,3])
C0370003 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
C0007124 (UMLS CUI [3,3])
C1705248 (UMLS CUI [3,4])
C0184913 (UMLS CUI [4,1])
C0229985 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Disease Gross Unifocal | Disease Gross Multifocal | Invasive cancer | DCIS | Tumor size | Excision of neoplasm Negative Surgical Margin
Item
6. gross disease may be unifocal or multifocal with pathologic (invasive and/or dcis) tumor size excised with negative margins.
boolean
C0012634 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
C0443337 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0439806 (UMLS CUI [2,2])
C0205292 (UMLS CUI [2,3])
C0677898 (UMLS CUI [3])
C0007124 (UMLS CUI [4])
C0475440 (UMLS CUI [5])
C1299802 (UMLS CUI [6,1])
C1709157 (UMLS CUI [6,2])
Invasive carcinoma of breast | Requirement Axillary lymph nodes TNM clinical staging | Sentinel Lymph Node Biopsy | Sentinel Lymph Node Negative | Excision of axillary lymph nodes | Axillary lymph nodes sampling | Axillary lymph nodes Quantity | Sentinel Lymph Node Positive
Item
7. patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). axillary staging is not required for patients with dcis.
boolean
C0853879 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0729594 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0796693 (UMLS CUI [3])
C1522495 (UMLS CUI [4,1])
C1513916 (UMLS CUI [4,2])
C0193867 (UMLS CUI [5])
C0398420 (UMLS CUI [6])
C0729594 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C1522495 (UMLS CUI [8,1])
C1514241 (UMLS CUI [8,2])
Chemotherapy, Adjuvant | Radiotherapy, Adjuvant | Status post Operative Surgical Procedure Breast Carcinoma | Segmental Mastectomy | Reexcision Surgical margins | Axillary lymph nodes TNM clinical staging
Item
8. must begin adjuvant therapy (chemotherapy or radiotherapy) within 9 weeks following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure)
boolean
C0085533 (UMLS CUI [1])
C0242939 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0678222 (UMLS CUI [3,3])
C0024885 (UMLS CUI [4])
C0184913 (UMLS CUI [5,1])
C0229985 (UMLS CUI [5,2])
C0729594 (UMLS CUI [6,1])
C3258246 (UMLS CUI [6,2])
Hormone Receptor Analysis Primary tumor | Estrogen receptor assay Primary tumor | Progesterone receptor assay Primary tumor | Invasive cancer | HER2 Status Immunohistochemistry | HER2 Status FISH
Item
9. patients must have all usual and customary hormone receptor (er/pr) and estrogen receptor (er) analysis performed on the primary tumor prior to enrollment. patients with invasive disease must have her2 receptor status determined (positive or negative) with immuno-histochemistry (ihc) and/or fluorescent in-situ hybridization (fish).
boolean
C0019929 (UMLS CUI [1,1])
C0936012 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
C0201553 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C0373717 (UMLS CUI [3,1])
C0677930 (UMLS CUI [3,2])
C0677898 (UMLS CUI [4])
C1512413 (UMLS CUI [5,1])
C0021044 (UMLS CUI [5,2])
C1512413 (UMLS CUI [6,1])
C0162789 (UMLS CUI [6,2])
Medical History | Physical Examination | Bilateral mammography
Item
10. at the time of study enrollment, patients must have had a history & physical exam within 4 months and a bilateral mammogram within 6 months.
boolean
C0262926 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
C0203027 (UMLS CUI [3])
Malignant Neoplasms Disease Free Duration | Exception Breast Carcinoma | Patients Low Risk Recurrence | Carcinoma in situ of uterine cervix Treated | Colon Carcinoma In situ Treated | Malignant melanoma in situ Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated
Item
11. patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to enrollment and are deemed by their physician to be at low risk for recurrence. patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
C0034897 (UMLS CUI [3,3])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0699790 (UMLS CUI [5,1])
C0444498 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C0854696 (UMLS CUI [6,1])
C1522326 (UMLS CUI [6,2])
C0007117 (UMLS CUI [7,1])
C1522326 (UMLS CUI [7,2])
C0553723 (UMLS CUI [8,1])
C1522326 (UMLS CUI [8,2])
Residence Appalachian Region | Residence Rural area | Residence Nearby Radiotherapy facility | Patients Hardship | Patients Transportation hardship | Radiotherapy Conventional Fractionated | Hypofractionated radiation therapy
Item
12. patients must live in a county that is designated as appalachian and/or rural by kentucky cancer registry criteria (see list below) and/or must hold their primary residence at least 10 miles from the nearest radiation facility. patients who do not fit these criteria may still be considered eligible if they are determined to suffer significant financial and/or transportation hardship during a typical course of cf-rt or hf-rt (in the judgment of any of their treating physicians). patients who live outside the commonwealth of kentucky are eligible if they fit any of these aforementioned conditions.
boolean
C0237096 (UMLS CUI [1,1])
C0003609 (UMLS CUI [1,2])
C0237096 (UMLS CUI [2,1])
C0178837 (UMLS CUI [2,2])
C0237096 (UMLS CUI [3,1])
C1706276 (UMLS CUI [3,2])
C0337999 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C0032854 (UMLS CUI [4,2])
C0030705 (UMLS CUI [5,1])
C0040756 (UMLS CUI [5,2])
C0032854 (UMLS CUI [5,3])
C1522449 (UMLS CUI [6,1])
C0439858 (UMLS CUI [6,2])
C1979893 (UMLS CUI [6,3])
C1831786 (UMLS CUI [7])
Appalachian Region Specified
Item
appalachian counties in ky include: adair, bath, bell, boyd, breathitt, carter, casey, clark, clay, clinton, cumberland, edmonson, elliott, estill, fleming, floyd, garrard, green, greenup, harlan, hart, jackson, johnson, knott, knox, laurel, lawrence, lee, leslie, letcher, lewis, lincoln, madison, magoffin, martin, mccreary, menifee, metcalfe, monroe, montgomery, morgan, nicholas, owsley, perry, pike, powell, pulaski, robertson, rockcastle, rowan, russell, wayne, whitley, wolfe.
boolean
C0003609 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Gender | Gender Criteria Fulfill
Item
men are not eligible for this study. women with one or more of the following conditions are ineligible for this study.
boolean
C0079399 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Breast Carcinoma TNM Breast tumor staging
Item
1. t3, stage iii, or stage iv breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Axillary lymph nodes Positive Quantity
Item
2. more than 3 histologically positive axillary nodes
boolean
C0729594 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Axillary lymph nodes | Extension Extracapsular Microscopic | Extension Extracapsular Macroscopic
Item
3. axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
boolean
C0729594 (UMLS CUI [1])
C0231448 (UMLS CUI [2,1])
C1517049 (UMLS CUI [2,2])
C0205288 (UMLS CUI [2,3])
C0231448 (UMLS CUI [3,1])
C1517049 (UMLS CUI [3,2])
C0439806 (UMLS CUI [3,3])
Sentinel Lymph Nodes Positive Quantity | Exception Sentinel Lymph Nodes Axillary
Item
4. one or more positive non-axillary sentinel node(s) (note that intramammary nodes are staged as axillary nodes.)
boolean
C1522495 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1522495 (UMLS CUI [2,2])
C0004454 (UMLS CUI [2,3])
Axillary lymph nodes Ipsilateral Suspicious Palpable | Axillary lymph nodes Contralateral Suspicious Palpable | Supraclavicular lymph nodes Suspicious Palpable | Infraclavicular lymph nodes Suspicious Palpable | Internal mammary lymph nodes Suspicious Palpable | Axillary lymph nodes Ipsilateral Suspicious Radiography | Axillary lymph nodes Contralateral Suspicious Radiography | Supraclavicular lymph nodes Suspicious Radiography | Infraclavicular lymph nodes Suspicious Radiography | Internal mammary lymph nodes Suspicious Radiography | Exception Negative Lymph Node
Item
5. palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
boolean
C0729594 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0750493 (UMLS CUI [1,3])
C0522499 (UMLS CUI [1,4])
C0729594 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
C0750493 (UMLS CUI [2,3])
C0522499 (UMLS CUI [2,4])
C0229730 (UMLS CUI [3,1])
C0750493 (UMLS CUI [3,2])
C0522499 (UMLS CUI [3,3])
C0229743 (UMLS CUI [4,1])
C0750493 (UMLS CUI [4,2])
C0522499 (UMLS CUI [4,3])
C0542554 (UMLS CUI [5,1])
C0750493 (UMLS CUI [5,2])
C0522499 (UMLS CUI [5,3])
C0729594 (UMLS CUI [6,1])
C0441989 (UMLS CUI [6,2])
C0750493 (UMLS CUI [6,3])
C0034571 (UMLS CUI [6,4])
C0729594 (UMLS CUI [7,1])
C0441988 (UMLS CUI [7,2])
C0750493 (UMLS CUI [7,3])
C0034571 (UMLS CUI [7,4])
C0229730 (UMLS CUI [8,1])
C0750493 (UMLS CUI [8,2])
C0034571 (UMLS CUI [8,3])
C0229743 (UMLS CUI [9,1])
C0750493 (UMLS CUI [9,2])
C0034571 (UMLS CUI [9,3])
C0542554 (UMLS CUI [10,1])
C0750493 (UMLS CUI [10,2])
C0034571 (UMLS CUI [10,3])
C1705847 (UMLS CUI [11,1])
C0678034 (UMLS CUI [11,2])
Breast Microcalcification Ipsilateral Suspicious | Breast Microcalcification Contralateral Suspicious | Breast Density Ipsilateral Suspicious | Breast Density Contralateral Suspicious | Abnormality of the breast Ipsilateral Suspicious Palpable | Abnormality of the breast Contralateral Suspicious Palpable | Exception Abnormality Benign Biopsy
Item
6. suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
boolean
C0520594 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0750493 (UMLS CUI [1,3])
C0520594 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
C0750493 (UMLS CUI [2,3])
C1659543 (UMLS CUI [3,1])
C0441989 (UMLS CUI [3,2])
C0750493 (UMLS CUI [3,3])
C1659543 (UMLS CUI [4,1])
C0441988 (UMLS CUI [4,2])
C0750493 (UMLS CUI [4,3])
C4025829 (UMLS CUI [5,1])
C0441989 (UMLS CUI [5,2])
C0750493 (UMLS CUI [5,3])
C0522499 (UMLS CUI [5,4])
C4025829 (UMLS CUI [6,1])
C0441988 (UMLS CUI [6,2])
C0750493 (UMLS CUI [6,3])
C0522499 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C1704258 (UMLS CUI [7,2])
C0205183 (UMLS CUI [7,3])
C0005558 (UMLS CUI [7,4])
Breast Carcinoma not involving Epithelium | Sarcoma | Lymphoma
Item
7. non-epithelial breast malignancies such as sarcoma or lymphoma
boolean
C0678222 (UMLS CUI [1,1])
C0205429 (UMLS CUI [1,2])
C0014609 (UMLS CUI [1,3])
C1261473 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
Multicentric Breast Carcinoma Quadrant Quantity | Invasive cancer | DCIS
Item
8. proven multicentric carcinoma (invasive cancer or dcis) in more than one quadrant or separated by 4 or more centimeters
boolean
C2986664 (UMLS CUI [1,1])
C1631280 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0677898 (UMLS CUI [2])
C0007124 (UMLS CUI [3])
Paget's Disease of the Nipple
Item
9. paget's disease of the nipple
boolean
C1704323 (UMLS CUI [1])
Invasive carcinoma of breast Bilateral Synchronous | Breast Carcinoma Except Invasive carcinoma of breast
Item
10. synchronous bilateral invasive or non-invasive breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0439580 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0853879 (UMLS CUI [2,3])
Medical History Invasive cancer | Medical History DCIS
Item
11. history of invasive breast cancer or dcis (patients with a history of lobular carcinoma in situ (lcis) treated by surgery alone are eligible.)
boolean
C0262926 (UMLS CUI [1,1])
C0677898 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0007124 (UMLS CUI [2,2])
Surgical margins Microscopy Assessment Unsuccessful | Surgical margins Positive Evaluation Pathologic
Item
12. surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation (if surgical margins are rendered free of disease by reexcision, the patient is eligible.)
boolean
C0229985 (UMLS CUI [1,1])
C0026018 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
C0229985 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C1521733 (UMLS CUI [2,4])
Radiotherapy to lymph nodes regional
Item
13. treatment plan that includes regional nodal irradiation
boolean
C1504399 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
Antineoplastic Agents, Hormonal | Raloxifene | Evista | Tamoxifen | Selective Estrogen Receptor Modulators | Prophylactic treatment Osteoporosis | Prophylactic treatment Breast Carcinoma
Item
14. current therapy with any hormonal agents such as raloxifene (evista®), tamoxifen, or other selective estrogen receptor modulators (serms), either for osteoporosis or breast cancer prevention (patients are eligible only if these medications are discontinued prior to enrollment.)
boolean
C0282559 (UMLS CUI [1])
C0244404 (UMLS CUI [2])
C0720318 (UMLS CUI [3])
C0039286 (UMLS CUI [4])
C0732611 (UMLS CUI [5])
C0199176 (UMLS CUI [6,1])
C0029456 (UMLS CUI [6,2])
C0199176 (UMLS CUI [7,1])
C0678222 (UMLS CUI [7,2])
Breast implants cosmetic
Item
15. cosmetic breast implants (patients who have had implants removed are eligible.)
boolean
C0179412 (UMLS CUI [1,1])
C0010164 (UMLS CUI [1,2])
Radiotherapy to breast | Radiotherapy to thorax
Item
16. prior breast or thoracic rt for any condition
boolean
C0948310 (UMLS CUI [1])
C4038705 (UMLS CUI [2])
Collagen-vascular disease | Dermatomyositis | Elevated creatine kinase | Exanthema | Lupus Erythematosus, Systemic | Scleroderma
Item
17. collagen vascular disease, specifically dermatomyositis with a cpk level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma
boolean
C0262428 (UMLS CUI [1])
C0011633 (UMLS CUI [2])
C0151576 (UMLS CUI [3])
C0015230 (UMLS CUI [4])
C0024141 (UMLS CUI [5])
C0011644 (UMLS CUI [6])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Exception Hormonal contraception
Item
18. pregnancy or lactation at the time of proposed randomization. women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2985296 (UMLS CUI [4,2])
Mental disorders Exclude Protocol Compliance | Addictive Behavior Excludes Protocol Compliance | Condition Excludes Protocol Compliance
Item
19. psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
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