An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

PRIMARY OBJECTIVE:

To test the safety and tolerability of an alternative fractionation regimen in locally
advanced non-small cell lung cancer (NSCLC), consisting of 44 Gy with concurrent chemotherapy
followed by a stereotactic body radiation therapy (SBRT) boost to remaining parenchymal and
nodal disease. The maximum tolerated dose of the SBRT boost will be determined.

SECONDARY OBJECTIVES:

1. To assess local control.

2. To assess distant metastasis and patterns of failure.

3. To assess overall survival at 1 and 2 years.

OUTLINE: This is a dose-escalation study of radiation therapy and SBRT.

Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for
4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.

After completion of study treatment, patients are followed up for 5 years.

Inclusion Criteria:

- Biopsy proven NSCLC, within 8 weeks prior to patient registration

- Unresectable disease

- Clinical stage Tx, T1-T4, N1-3, M0

- Karnofsky performance status (KPS) ≥ 70

- Pretreatment positron emission tomography (PET) CT scan to rule out metastatic disease

- The primary tumor may not be larger than 8 cm in maximum dimension

- If the primary tumor is central in location, defined as within 2 cm from the
tracheobronchial tree, it must be no larger than 5 cm

- Mediastinal and hilar lymphadenopathy can be no larger than 5 cm at any nodal
station

- Pretreatment brain CT with contrast or brain MRI to rule out metastases

- Pathologic assessment of the mediastinum to document involved nodal stations

- All of the above inclusion criteria must occur within 8 weeks prior to patient
registration, with the exception of pathologic assessment of the mediastinum and
biopsy to confirm NSCLC, which can be done within 12 weeks of patient registration

Exclusion Criteria:

- Prior history of lung cancer

- Pregnancy

- Prior history of radiation to the chest