Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

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: Not yet recruiting
• Conditions: Cancer; Metastatic Cancer; Locally Advanced Solid Tumor; Locally Advanced; Locally Advanced Carcinoma
• Intervention / Treatment: Radiation: Lattice therapy (LRT)

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

• Study Contact: Name: UCCC Clinical Trials Office; Phone Number: 513-584-7698; Email: cancer@uchealth.com
• Study Contact Backup: Name: Andrew Frankart, MD

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	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	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.	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

• Sponsor: University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 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 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; Radiation; Palliative; Palliation; Bulky; Spatial fractionation; Lattice therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• 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