Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

April 28, 2026 updated by: Andrew Frankart, University of Cincinnati

A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Andrew Frankart, MD

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
          • Andrew Frankart, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • Age ≥18 years.
  • ECOG Performance status ≤2
  • Life expectancy greater than 3 months
  • Women of child-bearing potential and men must agree to avoid conception via abstinence (ideal) or a method of birth control (e.g., hormonal or barrier method of birth control) prior to study entry and for at least 30 days after completion of lattice therapy administration.
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • 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
  • Patients with uncontrolled intercurrent illness
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lattice radiation therapy (LRT)
Lattice radiation therapy (LRT) : 5 fractions
Radiation: Lattice therapy (LRT)
5 Fractions LRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: 60 days post treatment
To evaluate the efficacy of lattice therapy in patients with bulky tumors, as measured by objective response rate (ORR) at 60 days post-treatment.
60 days post treatment
Adverse Events
Time Frame: Up to 60 days post-treatment
To characterize the safety profile and adverse events (AEs) of lattice therapy.
Up to 60 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 12 months post treatment
To assess overall survival (OS) following lattice therapy. Overall survival will be assessed via review of medical and vital records.
12 months post treatment
Patient-reported Quality of Life
Time Frame: 60 days post treatment
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.
60 days post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Lattice Therapy on Systemic Immune Anti-tumor Responses via analysis of peripheral blood samples.
Time Frame: Up to 5 days post-treatment
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.
Up to 5 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCCC-RT-23-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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