A Pilot Study of Stereotactic Body Radiation Therapy (SBRT) After TEMLA for Stage III and IV (Oligometastatic) Non-Small Cell Lung Cancer
I. To assess the feasibility/toxicity of combining transcervical extended mediastinal
lymphadenectomy (TEMLA) with or without minimally invasive surgery and stereotactic body
radiation therapy (SBRT).
I. To assess time to initiation of chemotherapy following TEMLA with or without minimally
invasive surgery and SBRT.
II. To assess feasibility/toxicity of combining TEMLA with or without minimally invasive
surgery with various chemotherapy regimens (to be determined by medical oncologist based on
patient and tumor characteristics).
III. To estimate survival following TEMLA with or without minimally invasive surgery and
IV. To define any differences in quality of life/toxicity following TEMLA with or without
minimally invasive surgery and SBRT based on tumor location (peripheral/central).
Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction
of SBRT to the primary tumor and mediastinal lymph node beds (if positive on TEMLA), with or
without minimally invasive surgery.
After completion of study treatment, patients are followed up at 6, 9, and 12 months, and
then every 6 months for 4 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals.
Up to 5 years
Roswell Park Cancer Institute
United States: Institutional Review Board
|Roswell Park Cancer Institute||Buffalo, New York 14263|