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The GammaPod machine was made by Xcision Medical Systems and is already FDA cleared to deliver focused radiation within the breast. Unlike current radiation machines, the GammaPod was designed specifically for treating breast cancer. The GammaPod can pinpoint radiation to the tumor bed in the breast which lowers the amount of radiation to nearby tissues. The machine uses a breast cup system to hold the breast in place for the treatment. This breast cup system was tested at MSGCCC (Marlene Stewart Greenebaum Comprehensive Cancer Center). Patients reported this system was more comfortable than an MRI or mammogram. The cup system was able to securely position the breast for treatment in the correct location.
Receiving radiation before surgery is not a new concept in cancer management. Preoperative radiation has proven to result in improved disease free survival in certain types of cancer.
With this study treatment, the participants will receive a dose of breast radiation therapy before the lumpectomy surgery. The lumpectomy surgery is where they remove the participant's tumor.
The purpose of this research study is to determine a safe and effective dose of pre-operative radiation to treat early stage breast cancer. The pre-operative radiation is delivered using the FDA approved, GammaPod machine. The study will also determine the cosmesis of pre-operative radiation at different doses. Cosmesis is another word for looking at skin changes. The research team will use questionnaires for patient and physicians to assess adverse cosmesis changes as accurately as possible. In addition, the investigators are going to assess radiation related changes using photo software analysis tools and patients quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1: 21 Gy | Active Comparator | Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy. |
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| Dose Level 2: 24 Gy | Active Comparator | Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy. |
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| Dose Level 3: 27 Gy | Active Comparator | Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy. |
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| Dose Level 4: 30 Gy | Active Comparator | Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GammaPod Radiation | Radiation | The basic design is a dose-escalation phase Ib study with 4 predefined dose levels. With this study treatment, participants will receive the dose level assigned treatment of radiation therapy before the lumpectomy surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Establish the single-fraction radiation dose (MTD) | To establish the single-fraction radiation dose (MTD) delivered with the GammaPod that causes an incidence of dose-limiting toxicities (DLTs) that is statistically significantly 10% or lower. | 5 years |
| Incidence of Dose-Limiting Toxicities (DLTs) | The primary endpoint is DLTs defined as one or more instances of:
| 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod | To establish the comprehensive safety profile of single-fraction PBI delivered with the GammaPod. The following secondary toxicity and quality-of-life endpoints will be collected and reported:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Nichols, MD | Contact | 410-328-6080 | enichols1@umm.edu | |
| Caitlin Eggleston | Contact | 410-328-7586 | caitlineggleston@umm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Nichols, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMMC | Recruiting | Baltimore | Maryland | 21201 | United States |
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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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| 5 years |
| Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod | To establish the comprehensive safety profile of single-fraction PBI delivered with the GammaPod. The following secondary toxicity and quality-of-life endpoints will be collected and reported: -Rates of surgical morbidity (defined below), including seroma formation. Seroma will be defined as any palpable seroma on follow-up exam. If seroma results in pain/discomfort and/or requires drainage this should be noted as a 'symptomatic' seroma. Seroma formation is normal following lumpectomy surgery but is asymptomatic in the majority of cases. | 5 years |
| Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod | To establish the comprehensive safety profile of single-fraction PBI delivered with the GammaPod. The following secondary toxicity and quality-of-life endpoints will be collected and reported: -Patient and physician-assessed cosmesis after radiotherapy and surgery via questionnaire. | 5 years |
| Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod | To establish the comprehensive safety profile of single-fraction PBI delivered with the GammaPod. The following secondary toxicity and quality-of-life endpoints will be collected and reported: - Patient Quality of Life Assessments [EORTC QLQ-C30- scale goes from 1/not at all to 4/very much. There is additionally a rate of overall health and quality of life that is a scale from 1 to 7.] | 5 years |
| Rate of pathologic complete response (pCR) | To establish the rate of pathologic complete response (pCR) as a function of dose. pCR will be scored by pathology review of H&E slides. | 5 years |
| Rate of ipsilateral local tumor recurrence | Report ipsilateral local tumor recurrence using the Kaplan-Meier method. | 5 years |
| Upper Chesapeake Health | Recruiting | Bel Air | Maryland | 21014 | United States |
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| Central Maryland Oncology Center | Recruiting | Columbia | Maryland | 21044 | United States |
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| Baltimore Washington Medical Center | Recruiting | Glen Burnie | Maryland | 21061 | United States |
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| D017437 |
| Skin and Connective Tissue Diseases |