Image-Guided Hypofractionated Radiotherapy With Stereotactic Boost and Chemotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer
I. To determine the maximum tolerated dose (MTD) using hypofractionated RT in patients with
stage II-III NSCLC.
I. To determine the dose-limiting toxicity, if the MTD is reached.
II. To determine the tumor local control (LC).
III. To determine the lung cancer disease specific survival (DSS).
IV. To determine the overall survival (OS).
V. To assess the transforming growth factor-beta (TGF-B), interleukin (IL)-1, and IL-6
levels as predictive biomarkers for treatment induced tissue injury.
OUTLINE: This is a dose-escalation study of image-guided hypofractionated RT.
Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks
followed by 5 fractions of hypofractionated RT boost. Patients also receive standard
carboplatin and paclitaxel for 3 weeks.
After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months
for the first 2 years, and then periodically thereafter.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximal tolerated dose using hypofractionated radiotherapy in patients with stage II-III non small cell lung cancer.
The primary end point is to reach the maximum tolerated dose or a total of 75 Gy, whichever comes first, by escalating the daily dose of last 5 fractions.
up to 90 days
Jonsson Comprehensive Cancer Center
United States: Institutional Review Board
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