GCC 1926- Phase Ib Dose Escalation of Single-Fraction Preoperative Stereotactic Partial-Breast Irradiation for Early-Stage Breast Cancer
Summary
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.
Arms & interventions
- RadiationGammaPod 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.
Outcome measures
Primary
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.
Time frame: 5 years
Incidence of Dose-Limiting Toxicities (DLTs)
The primary endpoint is DLTs defined as one or more instances of: * Surgical infection: Defined as redness that resolves on antibiotics (sometimes the surgical site may look red as a result of natural healing processes and does not resolve with antibiotics) with or without fever and/or elevated white blood cell count. The risk of infection for this surgical procedure (lumpectomy ± SLN biopsy) is \<5%. * Nonhealing surgical incision (\>30 days). The risk is \<5%. * Reoperation secondary to infection/wound healing problem. Risk is \<5%.
Time frame: 5 years
Secondary
Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
Time frame: 5 years
Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
Time frame: 5 years
Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
Time frame: 5 years
Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
Time frame: 5 years
Rate of pathologic complete response (pCR)
Time frame: 5 years
Rate of ipsilateral local tumor recurrence
Time frame: 5 years
Eligibility criteria
Study locations (4)
UMMC
Baltimore, Maryland, 21201
Upper Chesapeake Health
Bel Air, Maryland, 21014
Central Maryland Oncology Center
Columbia, Maryland, 21044
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061