The primary objective of this study is disease free survival rate at 5 years in stage IA2 (T1aN0M0 or T1bN0M0 only) non-small cell lung cancer (NSCLC) patients treated either by surgery or stereotactic body radiation therapy (SBRT).
Today, the best medical literature available confirms that surgery is superior to radiation therapy in the treatment of the early stage lung cancer. However, good emerging data demonstrates potential equality between these two treatments. Two major international studies have tried to compare both treatments but have failed to complete the study because of the lack of patients accrual. We chose to design a trial in which patients will be part of a shared decision making process in selecting the treatment modality. Patients with early stage lung cancer, that can undergo surgical treatment will be offered SBRT, and in conjunction with the pulmonologist will decide which treatment they prefer. We intend to complete the recruitment of patients within 02 years, then follow-up for 5 more years to collect data.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Lung Cancer Anatomical Resection
SBRT treatment. 48Gy in 4 sessions for peripheral lesions and 50Gy in 5 sessions for central lesions.
Hôtel-Dieu de Québec (CHUQ)
Québec, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
Québec, Quebec, Canada
Disease free survival
To compare the disease free survival of patients with Stage up to IA2 (T1aN0M0 or T1bN0M0) NSCLC managed either by SBRT or surgery.
Time frame: 5 years
Overall Survival
Overall survival rate at 5 years in both arms
Time frame: 5 years
Level of morbidity
Level of morbidity in both arms (CTCAE 4.0 - common toxicity criteria)
Time frame: 5 years
Level of efficacy in the SBRT arm
Level of efficacy in the SBRT arm (RECIST 1.1)
Time frame: 5 years
QOL assessment
QOL assessment with SF36 questionnaire (pre and post treatment) in both arms
Time frame: 5 years
FEV1 and DLCO decline at 1-year post-treatment in both arms
FEV1 or DLCO decline at 1-year post-treatment in both arms
Time frame: 1 year
Health economic evaluation in both arms
Health economic evaluation in both arms
Time frame: 5 years
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