This phase I/II trial is studying the side effects and best dose of proton beam radiation therapy when given together with cisplatin and etoposide and to see how well it works in treating patients with stage IIIA non-small cell lung cancer (NSCLC) that can be removed by surgery. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue in patients with NSCLC. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving proton beam radiation therapy together with combination chemotherapy may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01076231.
PRIMARY OBJECTIVES:
I. The primary objectives are to determine feasibility and dose-limiting toxicity.
SECONDARY OBJECTIVES:
I. To determine the pathologic complete response (CR) rate which is defined as the fraction of patients who undergo surgery and have no evidence of disease based on surgical pathology at the maximum tolerated dose (MTD) and use a Simon minimax design to compare the study path CR rate of the historical rate of 15%.
II. To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy.
III. To assess acute side effects from irradiation using proton beam therapy in place of conventional photon beam therapy.
IV. 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.
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 intravenously (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.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorJacob E Shabason
