Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer

This protocol will investigate the potential role of SBRT for patients with stage 3 NSCLC.
Eligible patients will first have received standard 50.4 Gy chemoradiation. Patients entering
the study will have the opportunity to receive SBRT as a noninvasive option as compared to
surgical resection. For patients who are not surgical candidates, SBRT after 50.4 Gy
chemoradiation represents a technique of radiation consolidation that may be more effective
and less toxic than standard conventional fractionated radiation

PATIENT ELIGIBILITY Conditions for Patient Eligibility (Inclusion)

- Pathologically or cytologically confirmed NSCLC

- Stage III NSCLC according to the AJCC 7th edition staging criteria. Stage II (T1-3N1)
patient that are deemed medically inoperable are also eligible.

- Concurrent chemoradiation to a radiation dose of 50.4 Gy.

- residual tumor volume after concurrent chemoradiation that is appropriate for SBRT:

- Primary tumor <120cc (approximately 6cm diameter).

- Mediastinal/Hilar disease: 1-2 involved regions <60cc (approximately 5cmx3cmx3cm)

- Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL.

- Total bilirubin ≤ 2x upper institutional limit of normal (ULN), and AST or ALT ≤5x
ULN.

- ECOG performance status 0 to 2

- Minimum life expectancy of 12 weeks.

- Age older than 18 years.

- Voluntary, signed written informed consent.

- Women of childbearing potential must have a negative pregnancy test

- Men and women of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 1 months thereafter.

Conditions for Patient Ineligibility (Exclusion)

- Disease progression during or after standard chemoradiation to 50.4 Gy

- Prior thoracic radiation other than the pre-operative radiation not greater than 50.4

- Metastatic disease

- Uncontrolled severe, intercurrent illness.

- Women who are breast-feeding.

- No chemotherapy within 2 weeks from the first SBRT treatment.

- Concurrent anticancer therapy.

- Prior complete resection of all NSCLC.