Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung

The introduction of stereotactic body radiation therapy (SBRT) has allowed safe dose
escalation in treatment regimens for cancer. Several studies have shown a radiation
dose-response relationship for survival and local control for tumors of the lung, including
cancer that originates in the lung (such as non-small cell lung cancer) as well as cancer
that metastasizes to the lung.

The purpose of this study is to determine the response rate and toxicity of SBRT treatment of
patients with lung tumors. This study will use a dose of 60 gray (Gy) in 5 fractions of 12
Gy. This provides a biological equivalent dose with alpha/beta ratio of 10 (BED10) of 132 Gy
with the anticipation of achieving local control without increased toxicity. Previous studies
have shown that the response rate with SBRT across multiple studies is approximately 50%,
with an additional 25-40% of patients having stable disease. We hypothesize that this regimen
will achieve a response rate of 70% with grade 3 toxicity of less than 5%.

Inclusion Criteria:

1. Histologic confirmation of non small cell lung cancer or other solid primary tumor
metastatic to lungs

2. Medically inoperable stage I or II non small cell lung cancer with negative lymph
nodes or metastatic cancer to lung with less than or equal to 3 lesions

3. Age greater than or equal to 18 years old

4. Zubrod performance status less than or equal to 1

5. Negative pregnancy test for women of child bearing potential

6. Informed consent

7. Each lesion must be less than or equal to 5 cm in maximal diameter and multiple
lesions must be less than or equal to 18 cm for the sum of the diameters in 3
dimensions. Example: 3 lesions each 2+2+2 cm have an aggregate diameter of 18 cm which
is acceptable.

8. No prior radiation to lesions being treated

9. For metastatic disease to lung, primary tumor needs to be controlled (no evidence of
progression on imaging for at least 2 months).

Exclusion Criteria:

1. Contraindications to radiation

2. Within or touching the zone of proximal bronchial tree defined as a volume 2 cm in all
directions around the proximal bronchial tree (carina, right and left main bronchi,
right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus,
lingular bronchus, right and left lower lobe bronchi)

3. Pregnant or lactating females who chose to breast feed

4. Patients must have recovered from toxicity of prior therapy

5. Any co morbid condition that' in the view of the attending physician' renders the
patient at high risk from treatment complications

6. Cytologically positive pleural effusion