Registry for GammaPod and Quality of Life in Breast Cancer
Tumor Bed Boost Using a Breast Specific Radiosurgery Device, The GammaPodTM: Registry Study and Evaluation of Quality of Life With Development of Sizing Nomogram
This study is testing how well the GammaPod treatment works for women with early-stage breast cancer who have had surgery, while also looking at how it affects their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | radiation |
| Locations | 4 sites (Bel Air, Maryland and 3 other locations) |
| Trial ID | NCT03562273 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on patient outcomes, adverse events, and dosimetric characteristics associated with the GammaPod, a device used for delivering a single-fraction boost in breast cancer treatment. It focuses on women who have undergone breast-conserving therapy after surgical lumpectomy for early-stage breast cancer. The study will evaluate the feasibility and effectiveness of this treatment approach while also assessing the quality of life of participants. By gathering this information, the study seeks to improve treatment protocols and patient care in breast cancer management.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and older with a diagnosis of invasive or non-invasive breast cancer who have undergone partial mastectomy and are suitable for breast-conserving therapy.
Not a fit: Patients who have had prior radiation to the treated breast or are not candidates for breast-conserving therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for breast cancer patients by optimizing radiation therapy techniques.
How similar studies have performed: Previous studies have shown promising results with similar approaches in breast cancer treatment, indicating potential for success in this registry.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient must sign consent for study participation. * The patient must be female and have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomy. * The patient must be deemed an appropriate candidate for breast conserving therapy (i.e. not pregnant, never had radiation to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy). * Patients with involved lymph nodes are candidates for the study. * Surgical margins are negative for invasive (no tumor on ink) or non-invasive breast cancer (2 mm negative margin). * The greatest dimension of the tumor is less than 4cm before surgery. * Multifocal disease is allowed if it was removed by a single lumpectomy resection and the patient remained a candidate for breast conservation. * Age 18 years and older. * Women of childbearing potential (pre-menopausal defined as having a menstrual period within the past 1 year) must have a negative serum pregnancy test or complete a pregnancy waiver form per institutional policy. * The surgical cavity is clearly visible on CT images. Of note, clips are not required but recommended. * The patient must weigh less than 150Kg (330lb), which is the limit of the imaging couch. * The patient must be less than 6'6" in height. * The patient must feel comfortable in the prone position. * Diagnosis of prior contralateral breast cancer is allowed. * Diagnosis of synchronous bilateral cancers is allowed. In this case if bilateral boosts are required, a patient would not have both treatments on the same day. * Oncoplastic reduction surgery is allowed if the lumpectomy cavity can be clearly visualized. Exclusion Criteria: * Patients with proven multi-centric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm). * Prior radiation therapy to that breast or that hemi thorax. * Unable to fit into the immobilization breast cup with an adequate seal. * Male gender. * Patient cannot comfortably be set up in the prone position (i.e. physical disability) * Unable to fit into the breast immobilization device due to breast size or other anatomical reason. * Mastectomy is the surgery performed. * Patient has received prior radiotherapy to the involved breast. * Tumor bed is less than 3 mm from the skin surface. * Greater than 50% of the target volume is above the upper border of the table. * Patients with skin involvement, regardless of tumor size. * Patients with connective tissue disorders specifically systemic lupus erythematosis, scleroderma, or dermatomyositis. * Patients with psychiatric or addictive disorders that would preclude obtaining informed consent. * Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females. * Patients with breast implants/tissue expanders or flap reconstruction.
Where this trial is running
Bel Air, Maryland and 3 other locations
- Upper Chesapeake Health — Bel Air, Maryland, United States (Recruiting)
- Central Maryland Oncology Center — Columbia, Maryland, United States (Recruiting)
- Baltimore Washington Medical Center — Glen Burnie, Maryland, United States (Recruiting)
- UTSouthwestern — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth M. Nichols, M.D. — University of Maryland
- Study coordinator: Elizabeth M. Nichols, M.D.
- Email: enichols1@umm.edu
- Phone: 410-328-2324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.