Proton Beam Radiation Therapy in Patients With Resected N2 Non-Small Cell Lung Cancer
Summary
This clinical trial tests proton beam radiation therapy in patients with non-small cell lung cancer who have undergone surgical resection and have lymph nodes involving the middle of the chest. Proton therapy is a type of radiation treatment that kills cancer cells while avoiding surrounding healthy tissue. Proton beam therapy is sometimes used after cancer surgery to reduce the risk of cancer recurrence (coming back). Giving proton beam radiation therapy may work better than conventional radiation treatment after surgery in patients with non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVE: I. To assess the safety of proton beam radiation therapy (PBRT) for resected N2 non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To measure the radiation dose to the circulating immune compartment and explore its association with clinical endpoints. II. To assess the efficacy of PBRT for resected N2 NSCLC. OUTLINE: Patients undergo radiation treatment planning and then undergo proton beam radiation therapy on study. Patients also undergo collection of blood samples. Patients are followed up for 24 months after first dose of radiotherapy.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- RadiationProton Beam Radiation Therapy
Undergo proton beam radiation therapy
- OtherRadiology, Treatment Planning
Undergo radiation treatment planning
Outcome measures
Primary
Incidence of adverse events (AEs)
AEs will be categorized according to Common Terminology Criteria for Adverse Events (CTCAE) and classified as either early (occurring any time from enrollment through 90 days) or late (occurring any time from 90 days through 2 years). Will also categorize toxicity according to grade and separately report toxicity of any grade and toxicity of high grade (grade 3 or greater). Descriptive statistics will be used to summarize the data.
Time frame: Up to 90 days from enrollment
Secondary
Radiation dose to immune compartment
Time frame: Single episode prior to first radiation treatment
Disease-free survival
Time frame: From date of surgery to the date of local, regional, or distant recurrence or death, whichever earlier, with censoring at the date of the last follow up, assessed up to 24 months after first dose of radiation
Overall survival
Time frame: From the date of surgery to the date of death with censoring at date of last follow up if alive, assessed up to 24 months after first dose of radiation
Eligibility criteria
Study locations (1)
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322