The purpose of this research study is to determine if lattice radiation therapy (LRT) will provide better treatment for bulky (large) tumors than current standard of care radiotherapy.
This will be a single-institution, single-arm Phase II trial with an anticipated total of 37 patients enrolled. Treatment will consist of 5 fractions of lattice radiation therapy delivered every other day. The primary endpoints will include the efficacy of lattice therapy as evaluated by ORR (CR or PR per RECIST criteria) at 60 days (2 months) post-treatment and safety. Toxicity will be evaluated at day 5 (+/- 2 days), day 15 (+/- 5 days), day 30 (+/- 5 days), and day 60 (+/- 7 days) post-completion of lattice therapy. This study will also include a translational analysis of the impact of lattice therapy on systemic immune responses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
5 Fractions LRT
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
RECRUITINGOverall Response Rate
To evaluate the efficacy of lattice therapy in patients with bulky tumors, as measured by objective response rate (ORR) at 60 days post-treatment.
Time frame: 60 days post treatment
Adverse Events
To characterize the safety profile and adverse events (AEs) of lattice therapy.
Time frame: Up to 60 days post-treatment
Overall Survival
To assess overall survival (OS) following lattice therapy. Overall survival will be assessed via review of medical and vital records.
Time frame: 12 months post treatment
Patient-reported Quality of Life
To determine patient-reported quality of life outcomes after lattice therapy via the Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7) tool as a measure of global quality of life. This is measured on 5 point Likert-type scale ranging from 0-4. Higher scores reflect better QOL.
Time frame: 60 days post treatment
Andrew Frankart, MD
CONTACT
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