This phase I trial studies how well pulsed low dose radiation therapy and chemotherapy work in reducing the rates of severe acute esophagitis in patients with stage IIIA non-small cell lung cancer and stage IB-IIIC esophageal cancer. Pulsed low dose rate radiation therapy uses short pulses to deliver low doses of radiation for extended times and may reduce the rate of severe acute esophagitis in patients with lung and esophageal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03094884.
PRIMARY OBJECTIVE:
I. To determine the rate of severe acute esophagitis in patients with lung cancer and esophageal cancer treated with concurrent chemotherapy and radiation therapy (CRT) using pulsed low dose rate (PLDR) technique.
SECONDARY OBJECTIVES:
I. To assess the rate of >= grade 2 radiation pneumonitis.
II. To assess quality of life (using questionnaires European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-30] and EORTC QLQ-Oesophageal Module 18 [OES18]).
III. To assess response rate based on surgical pathology.
IV. To assess progression-free survival (PFS).
OUTLINE:
Patients undergo PLDR radiation therapy via intensity modulated radiation therapy (IMRT) or volume modulated arc therapy (VMAT) over 27-30 minutes for 5 days a week for 5-6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive concurrent standard of care chemotherapy with carboplatin and paclitaxel followed by standard of care surgery 6-12 weeks later.
After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter until disease progression, death or up to 5 years after surgery.
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorJoshua E. Meyer
