GammaPod Registry and Quality of Life Nomogram
ConditionBreast Cancer Female
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
This study is a prospective, single arm study (registry) summarizing patient-level adverse-event and tumor outcomes as well as a number of feasibility and dosimetric characteristics of delivering a single-fraction boost with the GammaPod.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Women with breast cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Quality Of Life Sizing Nomogram
RadiationIf the participant meets the eligibility criteria of the study, and participant chooses to take part, they will receive the tumor bed boost in 8 Gy in 1 fraction just prior to starting whole breast radiation after joining the study. Treatment to the whole breast will begin within 7-8 days from the TB boost (GammaPodTM) treatment. The radiation therapy will take approximately 6 weeks to complete. Follow-up visits specifically for this study will continue for one year, although the physician will continue to follow as part of routine care.
Treatment groups
160 Participants
are divided into 1 treatment groupGroup A: GammaPod Quality of Life Evaluations1 intervention
Trial outcomes
Primary outcomes
1
Quality Of Life Evaluations
Evaluate the quality of life impact shortening treatment by 3-4 fractions may have on a patient via questionnaire(s).
Time frame
1 yearSecondary outcomes
1
GammaPod Nomogram construction
Development of a sizing nomogram for the breast immobilization device using a diagram representing the relations between three or more variable quantities by means of a number of scales, so arranged that the value of one variable can be found by a simple geometric construction, for example, by drawing a straight line intersecting the other scales at the appropriate values.
Time frame
1 year2
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
Evaluate acute toxicity of the GammaPod treatment during and up to 1 month following completion of the whole breast +/- LN portion of treatment using a questionnaire.
Time frame
~10 weeks3
Number of participants with treatment related adverse events as assessed by CTCAE v4.0 post one year from treatment
The evaluation of long-term toxicity at one year to assess the presence of subcutaneous fibrosis, and fat necrosis.
Time frame
~1.5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
University of Texas, Southwestern Medical Center at Dallas
Collaborator
Source ClinicalTrials.gov