Phase I Study: Locally Invasive NSCLC Treated With NEo-Adjuvant Stereotactic Body Radiation Therapy and REsection
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 Radiation Therapy (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.
View this trial on ClinicalTrials.gov
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