Trial Information

Feasibility and PhaseI/II Trial of Preoperative Proton Beam Radiotherapy With Concurrent Chemotherapy for Resectable Stage IIIA or Superior Sulcus NSCLC

PRIMARY OBJECTIVES:

I. To assess feasibility. (Phase I) II. To determine dose-limiting toxicity and maximum
tolerated dose. (Phase I) III. To determine the pathologic CR rate. (Phase II)

SECONDARY OBJECTIVES:

I. To assess late complications from irradiation using proton beam therapy in place of
conventional photon beam therapy. (Phase II) II. To assess acute side effects from
irradiation using proton beam therapy in place of conventional photon beam therapy. (Phase
II) III. To compare the dose distribution to tumor and surrounding normal structures using
DVH's (Dose Volume Histograms) generated from the proton plan used to treat the patient and
the photon plan generated for comparison purposes. (Phase II) IV. To determine
progression-free survival (Phase II) and late toxicity.

OUTLINE: This is a phase I, dose-escalation study of proton beam radiation therapy followed
by a phase II study.

Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent
chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5
and days 29-33.Treatment continues in the absence of disease progression or unacceptable
toxicity.

Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical
resection or additional chemoradiotherapy.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.