Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cincinnati

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Lattice therapy (LRT)

    Radiation

    5 Fractions LRT

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Lattice radiation therapy (LRT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
60 days post treatment
2

Adverse Events

To characterize the safety profile and adverse events (AEs) of lattice therapy.

Time frame
Up to 60 days post-treatment

Secondary outcomes

1

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
2

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

Other outcomes

1

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.

Time frame
Up to 5 days post-treatment

Sponsors and contacts

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