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This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be performed within 3 weeks (+/- 1 week) of completing radiation.
This study will assess the safety of partial breast radiosurgery as measured by the incidence of acute toxicity and wound healing complications in three dose cohorts.
Patients will be enrolled in cohorts of 8 patients starting at dose level 1 (15 Gy). If 2 or more dose limiting toxicities (DLTs) are observed at dose level 1, the trial will be stopped for evaluation and consideration of revision. If at most one DLT is observed then escalation continues to the next dose level. The cohorts will escalate by 3Gy up to 21 Gy of irradiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose radiosurgery: Dose Level 1 | Experimental | A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. |
|
| Single dose radiosurgery: Dose Level 2 | Experimental | A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. |
|
| Single dose radiosurgery: Dose Level 3 | Experimental | A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiosurgery | Radiation | Single dose or radiation in 15Gy, 18Gy or 21Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | As measured by the incidence of acute toxicity and wound healing complications | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic Outcome | Percent of patients with excellent or good cosmetic outcome at 3 years based on physician's assessment. EXCELLENT is defined as: when compared to the untreated breast or the original appearance of the treated breast, there is minimal or no difference in the size or shape of the treated breast. The way the breast feels (its texture) is the same or slightly different. There may be thickening, scar tissue, or seroma within the breast but not enough to change the appearance. GOOD is defined as: there is mild asymmetry between the breasts, which means that there is some acceptable difference in the size or shape of the treated breast as compared to the opposite breast or the appearance of the breast before treatment. There may be some mild reddening or darkening of the breast. The thickening or scar tissue within the breast causes a mild change in its shape or size. |
| Measure | Description | Time Frame |
|---|---|---|
| Acquire Tissue | Pre and post-radiotherapy for exploratory analysis of radiation response | Pre and post SRS radiosurgery |
| Magnetic Resonance Images(MRI) | Pre and post-radiotherapy for exploratory analysis of radiation response. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Blitzblau, MD PhD | Duke University Medical Center, Dept of Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11030294 | Background | Nattinger AB, Hoffmann RG, Kneusel RT, Schapira MM. Relation between appropriateness of primary therapy for early-stage breast carcinoma and increased use of breast-conserving surgery. Lancet. 2000 Sep 30;356(9236):1148-53. doi: 10.1016/S0140-6736(00)02757-4. | |
| 19395195 | Background | Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Dose Radiosurgery: Dose Level 1 | A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy |
| FG001 | Single Dose Radiosurgery: Dose Level 2 | A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy |
| FG002 | Single Dose Radiosurgery: Dose Level 3 | A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Dose Radiosurgery: Dose Level 1 | A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy |
| BG001 | Single Dose Radiosurgery: Dose Level 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose | As measured by the incidence of acute toxicity and wound healing complications | Participants receiving all dose levels (8 at 15Gy/Dose level 1, 8 at 18Gy/Dose level 2, 16 at 21Gy/Dose level 3) | Posted | Number | Gray (Gy) | 30 days |
|
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Dose Radiosurgery: Dose Level 1 | A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain -cardiac | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Mewshaw, MS RN | Assistant Research Practice Manager | (919) 668-5211 | Jennifer.Mewshaw@duke.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
| 3 years |
| Local Control | 3 years |
| Pre and post SRS radiosurgery |
| 16184459 | Background | Luini A, Orecchia R, Gatti G, Intra M, Ciocca M, Galimberti V, Veronesi P, Santos GR, Gilardi D, Veronesi U. The pilot trial on intraoperative radiotherapy with electrons (ELIOT): update on the results. Breast Cancer Res Treat. 2005 Sep;93(1):55-9. doi: 10.1007/s10549-005-3782-1. |
| 26488758 | Derived | Horton JK, Siamakpour-Reihani S, Lee CT, Zhou Y, Chen W, Geradts J, Fels DR, Hoang P, Ashcraft KA, Groth J, Kung HN, Dewhirst MW, Chi JT. FAS Death Receptor: A Breast Cancer Subtype-Specific Radiation Response Biomarker and Potential Therapeutic Target. Radiat Res. 2015 Nov;184(5):456-69. doi: 10.1667/RR14089.1. Epub 2015 Oct 21. |
A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy |
| BG002 | Single Dose Radiosurgery: Dose Level 3 | A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Cosmetic Outcome | Percent of patients with excellent or good cosmetic outcome at 3 years based on physician's assessment. EXCELLENT is defined as: when compared to the untreated breast or the original appearance of the treated breast, there is minimal or no difference in the size or shape of the treated breast. The way the breast feels (its texture) is the same or slightly different. There may be thickening, scar tissue, or seroma within the breast but not enough to change the appearance. GOOD is defined as: there is mild asymmetry between the breasts, which means that there is some acceptable difference in the size or shape of the treated breast as compared to the opposite breast or the appearance of the breast before treatment. There may be some mild reddening or darkening of the breast. The thickening or scar tissue within the breast causes a mild change in its shape or size. | Participants with a physician's assessment available. | Posted | Number | percentage of participants | 3 years |
|
|
|
| Secondary | Local Control | Data not collected. | Posted | 3 years |
|
|
| Other Pre-specified | Acquire Tissue | Pre and post-radiotherapy for exploratory analysis of radiation response | Not Posted | Pre and post SRS radiosurgery | Participants |
| Other Pre-specified | Magnetic Resonance Images(MRI) | Pre and post-radiotherapy for exploratory analysis of radiation response. | Not Posted | Pre and post SRS radiosurgery | Participants |
| 0 |
| 8 |
| 0 |
| 8 |
| 8 |
| 8 |
| EG001 | Single Dose Radiosurgery: Dose Level 2 | A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy Note: One participant in dose level 2 was killed in an unrelated motor vehicle accident and was not considered in all-cause mortality. | 1 | 8 | 0 | 8 | 8 | 8 |
| EG002 | Single Dose Radiosurgery: Dose Level 3 | A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy. Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy | 1 | 16 | 0 | 16 | 15 | 16 |
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Breast infection | Infections and infestations | Systematic Assessment |
|
| Infections and infestations-Other | Infections and infestations | Systematic Assessment |
|
| Rash pustular | Infections and infestations | Systematic Assessment |
|
| Skin infection | Infections and infestations | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fibrosis deep connective tissue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Superficial soft tissue fibrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Breast atrophy | Reproductive system and breast disorders | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Nipple deformity | Reproductive system and breast disorders | Systematic Assessment |
|
| Reproductive system and breast disorders-Other | Reproductive system and breast disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
| Lymphedema | Vascular disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |