Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

NCT06416007 | Recruiting Phase 2 DMC

• 1 other identifier: UCCC-RT-23-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Metastatic Cancer; Locally Advanced; Locally Advanced Carcinoma; Locally Advanced Solid Tumor

Keywords

Radiation; Radiotherapy; Bulky; Spatial fractionation; Lattice therapy; Palliative; Palliation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Overall Survival

  12 months post treatment

• Patient-reported Quality of Life

  60 days post treatment

Other Outcomes (1)

• Impact of Lattice Therapy on Systemic Immune Anti-tumor Responses via analysis of peripheral blood samples.

  Up to 5 days post-treatment

Study Arms (1)

Lattice radiation therapy (LRT)

EXPERIMENTAL

Lattice radiation therapy (LRT) : 5 fractions

Radiation: Lattice therapy (LRT)

Interventions

Lattice therapy (LRT) RADIATION

5 Fractions LRT

Lattice radiation therapy (LRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

UCCC Clinical Trials Office

CONTACT

513-584-7698; cancer@uchealth.com

Andrew Frankart, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 16, 2024
• Study Start: August 2, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)