Protocol Title:

A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With Locally Advanced Non-Small Cell Lung Cancer.

Protocol Status:

Closed

Protocol Number:

R 0214

Type of Cancer:

Lung cancer (non-small cell)

Principal Investigator :

Danny Song, MD

Research Nurse:

Shirl DiPasquale, RN

Phase Number:

III

General Eligibility:

Patients with newly diagnosed Stage IIIA or IIIB non-small cell lung cancer having completed definitive locoregional therapy (with surgery and/or radiation therapy, with or without chemotherapy) [chemotherapy alone does not constitute definitive therapy]) with complete response, partial response, or stable disease after therapy.
Patients must be = 18 years of age. Patients must be restaged and enrolled within 16 weeks of completing previous therapy; any acute/subacute = grade 3 toxicities from previous therapy must be resolved to = grade 2 at the time of study entry. No evidence of progressive disease at the time of study entry and MRI or CT of the head showing no suspicion for CNS metastases within 6 weeks of study entry. No evidence of extracranial distant
metastatic disease. No prior cranial irradiation. Patients may not be entered on other phase III studies. Pregnant
women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus.

Purpose:

Primary:
• Determine whether prophylactic cranial irradiation (PCI) improves survival after effective locoregional/systemic
therapy for patients with locally advanced non-small cell lung cancer.
Secondary:
• Determine the neuropsychologic impact of PCI, determine the impact of PCI on QOL, and determine the impact
of PCI on the incidence of CNS metastases.

Treatment:

Patients randomized to Arm 1 will receive prophylactic cranial irradiation (PCI) 2 Gy/fraction for 15 daily fractions for a dose of 30 Gy.
Those randomized to Arm 2 will remain under observation