Informed Consent
Item
1. must sign study-specific, irb approved informed consent form prior to study entry. note consent by legally authorized representative is not allowed for this trial.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. must be > = 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Life Expectancy | Age Related | Comorbidity Related | Breast Carcinoma Excluded
Item
3. must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer.
boolean
C0023671 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0678222 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
Breast Carcinoma | Invasive Ductal Breast Carcinoma | Lobular breast cancer Invasive
Item
4. must have pathology proven breast cancer. pathology must be invasive ductal or lobular
boolean
C0678222 (UMLS CUI [1])
C1134719 (UMLS CUI [2])
C3549742 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
TNM Breast tumor staging
Item
5. must meet stage ii - iii group criteria per ajcc staging manual 7th edition.
boolean
C0474926 (UMLS CUI [1])
Operation on breast | Mastectomy | Breast-Conserving Surgery | Segmental Mastectomy | Reexcision Surgical margins allowed
Item
6. must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. re-excision of surgical margins is permitted.
boolean
C3714726 (UMLS CUI [1])
C0024881 (UMLS CUI [2])
C0917927 (UMLS CUI [3])
C0024885 (UMLS CUI [4])
C0184913 (UMLS CUI [5,1])
C0229985 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
Multicentric Breast Carcinoma allowed | Paget Disease allowed
Item
7. note: multicentric breast cancer and paget's disease of the nipple are permitted.
boolean
C2986664 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C1368019 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Body Weight Pounds Quantity
Item
1. weight over 410 pounds.
boolean
C0005910 (UMLS CUI [1,1])
C0439219 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Malignant neoplasm of breast Not involving Epithelium | Sarcoma of breast | Breast Lymphoma
Item
2. non-epithelial breast malignancies such as sarcoma or lymphoma.
boolean
C0006142 (UMLS CUI [1,1])
C0205429 (UMLS CUI [1,2])
C0014609 (UMLS CUI [1,3])
C0349667 (UMLS CUI [2])
C1704251 (UMLS CUI [3])
Surgical margins | Assessment Microscopic Unsuccessful | Positive Surgical Margins | Exception Reexcision Surgical margins | Exception Surgical margins Free of Disease
Item
3. surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (if surgical margins are rendered free of disease by re-excision, the patient is eligible).
boolean
C0229985 (UMLS CUI [1])
C1516048 (UMLS CUI [2,1])
C0205288 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C1709603 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0184913 (UMLS CUI [4,2])
C0229985 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0229985 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0012634 (UMLS CUI [5,4])
Problem with female breast size Limitation Technical Problem
Item
4. breast size exceeding the technical limitation of daily set-up reproducibility. this may be center-specific and will be assessed at the discretion of the treating center.
boolean
C0850669 (UMLS CUI [1,1])
C0449295 (UMLS CUI [1,2])
C1710348 (UMLS CUI [1,3])
Breast tissue expander Postoperative Temporary | Requirement Individual needs assessment
Item
5. women with post-surgical temporary breast expanders will require individual assessment. depending on the manufacturing product and other treatment planning-specific details the patient may be eligible or may be deemed ineligible, as determined by treating investigator.
boolean
C0588162 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C0205374 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0679839 (UMLS CUI [2,2])
Breast Carcinoma Previous
Item
6. prior history of breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Irradiation of breast Previous | Radiotherapy to thorax Previous
Item
7. prior radiation to the breast or thorax.
boolean
C2148528 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C4038705 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Collagen-vascular disease | Dermatomyositis | Elevated creatine kinase | Exanthema | Lupus Erythematosus, Systemic | Scleroderma
Item
8. 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 | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Exception Hormonal contraception | Childbearing Potential Serum pregnancy test negative
Item
9. pregnancy or lactation at the time of proposed study entry. women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy such as an intrauterine device or condom with spermicide. (note: women of childbearing potential must have a negative serum pregnancy test within 3 weeks of study registration).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0021900 (UMLS CUI [4])
C0221829 (UMLS CUI [5])
C0087145 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C2985296 (UMLS CUI [7,2])
C3831118 (UMLS CUI [8,1])
C0430061 (UMLS CUI [8,2])
Mental disorders Protocol Compliance Excluded | Addictive Behavior Protocol Compliance Excluded | Condition Protocol Compliance Excluded
Item
10. 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])
C0525058 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Cancer Other | Exception Disease Free Duration | Exception Low Risk Recurrence | Exception Carcinoma in situ of uterine cervix Treated | Exception Colon Carcinoma In situ Treated | Exception Malignant melanoma in situ Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
11. prior history of non-breast malignancies unless they have been disease free for 5 or more years and are deemed by their physician to be at low risk for recurrence. further, patients who have the following cancers treated within the prior 5 years are permitted: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, basal cell or squamous cell carcinoma of the skin.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
C0034897 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0699790 (UMLS CUI [5,2])
C0444498 (UMLS CUI [5,3])
C1522326 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0854696 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0007117 (UMLS CUI [7,2])
C1522326 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0553723 (UMLS CUI [8,2])
C1522326 (UMLS CUI [8,3])