About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Solid tumor malignancy with a clinical indication for radiation
Patients must have measurable disease
Target lesion(s) which are amenable to lattice therapy plan
When applicable, target lesion for radiation amenable to immobilization during delivery of radiotherapy
Disqualifiers
Patients receiving cytotoxic chemotherapy or known radiosensitizing agents within 5 days before or after lattice therapy.
Patients with hematologic malignancies including lymphoma and leukemia as well as primary or metastatic central nervous system (CNS) malignancies.
Patients with a history of conditions which predispose them to increased radiation toxicity
Patients with known contraindications to radiation therapy
Trial design
Single group
Treatments tested in this trial
Lattice therapy (LRT)
Radiation5 Fractions LRT
Treatment groups
Trial outcomes
Primary outcomes
Overall 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.
Adverse Events
To characterize the safety profile and adverse events (AEs) of lattice therapy.
Secondary outcomes
Overall Survival
To assess overall survival (OS) following lattice therapy. Overall survival will be assessed via review of medical and vital records.
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.
Other outcomes
Impact of Lattice Therapy on Systemic Immune Anti-tumor Responses via analysis of peripheral blood samples.
Blood will be collected pre-treatment, after the last lattice fraction, and at 5 days post-lattice therapy for analysis via flow cytometry. Differences in immune anti-tumor responses be assessed between timepoints/tumor types. Increased immune anti-tumor responses after therapy compared to baseline are anticipated.
Sponsors and contacts
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