Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Procedure: therapeutic lymphadenectomy
Radiation: stereotactic radiosurgery
Other: quality-of-life assessment
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Stereotactic Body Radiation Therapy (SBRT) After TEMLA With or Without Minimally Invasive Surgery for Stage III and Stage IV (Oligometastatic) Non-small Cell Lung Cancer|
- Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals.
- Time until chemotherapy [ Time Frame: From the date of SBRT completion until the date of chemotherapy initiation, assessed up to 5 years ] [ Designated as safety issue: No ]A 90% confidence interval will be presented.
- Incidence of toxicity associated with combining TEMLA with or without minimally invasive surgery stratified by chemotherapy regimens [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]Exact 90% confidence intervals will be obtained for each unique chemotherapy regimen. Will be compared at each time-point between tumor locations using the Fisher's exact test.
- Overall survival [ Time Frame: From SBRT completion until death, assessed up to 5 years ] [ Designated as safety issue: No ]Will be described using standard Kaplan-Meier methodologies. The median survival time, 3-year survival rate, and 5-year survival rate and will be estimated and presented with 90% confidence intervals.
- Quality of life (QoL) scores from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ Lung Cancer-Specific Module [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Will be compared with cumulative toxicity rates at each time-point between tumor locations using the Mann-Whitney U test. Comparisons of QoL scores between time-points will be made using the Wilcoxon signed rank test.
|Study Start Date:||March 2013|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (TEMLA and SBRT)
Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without minimally invasive surgery.
Procedure: therapeutic lymphadenectomy
Undergo TEMLARadiation: stereotactic radiosurgery
Undergo SBRTOther: quality-of-life assessment
Other Name: quality of life assessment
I. To assess the feasibility/toxicity of combining transcervical extended mediastinal lymphadenectomy (TEMLA) with or without video-assisted thoracoscopic surgery (VATS) and stereotactic body radiation therapy (SBRT).
I. To assess time to initiation of chemotherapy following TEMLA with or without video-assisted thoracoscopic surgery (VATS)and SBRT.
II. To assess feasibility/toxicity of combining TEMLA with or without VATS and SBRT 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 VATS and SBRT. IV. To define any differences in quality of life/toxicity following TEMLA with or without VATS and SBRT based on tumor location (peripheral/central).
V. To assess response for primary tumor control and overall survival in TEMLA only patients.
VI. To assess progression free survival for TEMLA with or without (VATS) patients.
Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without VATS.
After completion of study treatment, patients are followed up at 6,9, and 12 months, every 6 months for 2 years and annually for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781741
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Anurag Singh||Roswell Park Cancer Institute|