Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below.

Immobilization of breast during radiation.

The Gamma Pod

CT simulation

Elizabeth M Nichols, MD

In this study, investigators plan to deliver a 8 Gy Tumor Bed (TB) boost using the Gamma Pod™ system followed by a conventional (50Gy in 25 fractions) or hypofractionated (40Gy in 15 fractions) course of whole breast radiation. The clinical target volume receiving 8 Gy will be the surgical cavity as defined by the surgical clips and post-surgical changes + 5 mm. The planning target volume (PTV) will add 5 mm to the clinical target volume to account for geometric uncertainties.

The current standard of care in our clinic when delivering a conventional course of whole breast radiation is to deliver between 60 and 66 Gy to the tumor bed when negative margins are achieved, with the initial \~45-50 Gy delivered to the whole breast and the 10-16 Gy TB boost delivered in 5-8 fractions.The current standard of care in our clinic when delivering a hypofractionated course of whole breast radiation is to deliver between 50 and 52 Gy to the tumor bed when negative margins are achieved, with the initial \~40-42.5 Gy delivered to the whole breast in 15 or 16 fractions respectively followed 10 Gy TB boost delivered in 4 or 5 fractions (total 20). The clinical target volume for the TB boost in this study is quite similar to conventional TB boost. The only difference is that the planning target volume margin is smaller in this study (5 mm instead of 10 mm) due to the reduced set up uncertainties with the breast cup immobilization and localization devices. The current institutional standard is covering the TB + 15 mm dosimetric margin. Since the reproducibility is improved by 5 mm with the aid of the breast immobilization cup, the TB + 10 mm dosimetric margin will be used on this study. Using the radiobiological equivalent dose (BED) formula, {BED = n D(1 + D/(α/β))}, the 8 Gy single fraction dose is equivalent to 16 Gy delivered in 8 fractions. Wherein the BED formula, n is the number of fractions, D is the dose per fraction and α/β is estimated to be between 3 and 4. On this study, the investigators will deliver either 40 Gy in fifteen (15) fractions (hypofractionated) or 50Gy in twenty-five (25) fractions (conventional) to the whole breast following a single 8 Gy boost using the Gamma Pod™. The summed dose to the boost region will be radiobiologically equivalent to a total dose of 52 (hypofractionated) or 66 Gy (conventional).

The safety and feasibility of delivering the boost dose to the tumor bed using a single fraction external beam is supported by past clinical trials. Besides the use of electrons and external beam from a linear accelerator, intracavitary balloons and intraoperative x-rays and electron beams have also been used to deliver a Tumor Bed (TB) boost. In the T A R G I T trial, a single dose of 20 Gy is delivered to the TB using the Intrabeam™ device while the dose drops to between 5 and 7 Gy 1 cm into the normal breast. With long term follow up (median follow-up of 60.5 months), the 5- year local recurrence rate was less than 2 %. In the largest intraoperative electron experience, investigators delivered 9 to 10 Gy in a single treatment prior to whole breast radiation using 9 (million electron volts) electrons. Long-term local control rates and cosmesis appear similar to or better than more conventional techniques. In this proposed study, the investigators plan to deliver 8 Gy to the TB rather than 20 Gy with low energy x-rays or 9-10 Gy with electrons before whole breast irradiation, based on 1) there is no benefit of dose escalation over the biological equivalent dose of 16 Gy at 2 Gy per fraction which is equal to 8 Gy in 1 fraction and 2) known increased side effects with higher doses to the tumor bed. The investigators believe that the proposed dose should be similarly tolerated as observed in these trials, since the volume of normal breast irradiated is similar using a lower dose. In addition, this treatment will similarly shorten treatment by 1 to 1½ weeks by replacing the 8 treatments to the TB.

The Gamma Pod: A Clinical Feasibility Study Device GCC 1202: The Gamma Pod: A Clinical Feasibility Study

(GCC 1202): Tumor Bed Dose Delivery Using a Breast Specific Radiosurgery Device. The Gamma Pod : A Clinical Feasibility Study

Patients must be undergoing breast conserving therapy and PI will evaluate for feasibility by ensuring coverage of the target volume with appropriate dose homogeneity and conformity as defined in the study. Per inclusion criteria, the volume of the tumor bed clinical target volume (CTV) is less than 25% of the whole breast planning target volume (PTV) which is a criteria used for partial breast alone trials (ie. NSABP B-39). If the tumor bed cannot fit this criteria, then patient is unable to be treated utilizing GammaPod.

Adverse events from the use of the adhesive spray was measured by photos taken pre-entry and during radiation.

University of Maryland, Baltimore

Principal Investigator

Systematic assessment during through regular physician assessments.

The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below.

The Gamma Pod: Immobilization of breast during radiation.

CT simulation: See arm description

Pilot Study

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity/Race

Race/Ethnicity, Customized

United States

Region of Enrollment

Elizabeth Nichols

Demonstration of the Feasibility and Safety of Delivering a Radiation Treatment Using the GammaPod (TM)

Number of Participants With Acute Toxicities Measured by Common Terminology Criteria for Adverse Events (CTCAE); The Evaluation of Acute Toxicity During and up to 1 Month After Gamma Pod TB Boost.

Number of Participants With Long-term Toxicities Measured by Common Terminology Criteria for Adverse Events (CTCAE); The Evaluation of Long-term Toxicity at One Year to Assess the Presence of Subcutaneous Fibrosis and Fat Necrosis.

Spots Global Cancer Trial Database for the gamma pod