Despite improved staging and operative techniques, the rate of incomplete resection (R1) of NSCLC has remained significant over the last decades. Patients with R1 resection have significantly worse survival compared to those with complete resection (R0). This is a phase I study that investigates the feasibility and safety of delivering Stereotactic Body Radiotherapy (SBRT) to patients with locally invasive NSCLC (cT3-4, N0-1) who are at risk for incomplete resection. Twenty patients with NSCLC will be treated with SBRT followed by surgery and appropriate adjuvant therapy. Patients will be divided into groups, of 5 patients each, treated with escalating doses (35, 40, 45 and 50 Gy) in 10 daily fractions. The primary outcome is the feasibility i.e. the ability to complete safely SBRT and surgery (within 6 weeks). Secondary outcomes include acute and late adverse events, R0/R1/R2 rates and secondary surrogates of feasibility. If successful, this study will lead to further evaluation of pre-operative SBRT in NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Dose escalation of neo-adjuvant SBRT in operable patients with locally advanced non-small cell lung cancer. The first cohort will be treated with a dose of 35 Gy in 10 fractions, the second cohort will be treated with a dose of 40 Gy in 10 fractions, the third cohort will be treated with a dose of 45 Gy in 10 fractions, the fourth cohort will be treated with a dose of 50 Gy in 10 fractions. The SBRT doses will be escalated only once all patients in the previous cohort will have completed safely their treatments.
Juravinski Cancer Centre
Hamilton, Ontario, Canada
RECRUITINGFeasibility of SBRT followed by surgery (proportion of patients who can undergo 10 fractions of SBRT followed by Surgery)
Feasibility of neo-adjuvant SBRT followed by surgery. This will be measured as the proportion of patients who can undergo 10 fractions of SBRT followed by Surgery as scheduled (within 6 weeks from registration).
Time frame: 18 months
Early safety of SBRT-S through collection of serious adverse events (CTCAE version 4.0 grade 3 or higher) from beginning of SBRT to 4 weeks after completion of surgery.
Time frame: 18 months
Late safety profile of SBRT-S through collection of surgical complication rates assessed at 6 and 18 months post-registration (thus 30 months from opening of the study, assuming it takes 1 year to complete accrual).
Complications recorded include incidence of bronchopleural fistula, esophageal fistula, wound healing complications (dehiscence, infection) and post-operative pulmonary complications).
Time frame: 30 months
Secondary feasibility outcomes (including accrual rate, consent rate, rates of deviation from scheduled treatment plan, and reasons for delay)
These include accrual rate, consent rate, rates of deviation from scheduled treatment plan of 6 weeks, and reasons for delay)
Time frame: 18 months
Pathological response following neoadjuvant SBRT (proportion of R0, R1 and R2 resections)
To determine the proportion of R0, R1 and R2 resections after neoadjuvant SBRT.
Time frame: 18 months
Pathologic changes associated with neo-adjuvant SBRT with analysis of irradiated tissues
Time frame: 18 months
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