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

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.

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 as long as regional
nodal radiation is not required by the treating physician.

- Surgical margins are negative for invasive or non-invasive breast cancer.

- The greatest dimension of the tumor is less than 4cm before surgery.

- The volume of the TB CTV is less than 25% of the whole breast PTV which is a criteria
used for partial breast alone trials (NSABP B-39).

- Multifocal disease is allowed if it was removed by a single lumpectomy resection and
the patient remained a candidate for breast conservation.

- Age 60 years and older.

- Women of childbearing potential must use an effective contraceptive method such as
condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription
birth control pills.A negative pregnancy test must be obtained prior to study
enrollment or waiver signed.

- The surgical cavity is clearly visible on CT images.

- The patient must weigh less than 150Kg (330lb), which is the limit of the imaging
couch.

- The patient must feel comfortable in the prone position.

Exclusion Criteria:

- Patients with proven multicentric carcinoma (tumors in different quadrants of the
breast or tumor separated by at least 4 cm).

- Prior radiation therapy above the umbilicus

- 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.

- Regional nodal irradiation is part of the treatment plan.

- Tumor bed is less than 5 mm from the skin surface.

- 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.