Lattice Radiotherapy for Adults With Large Tumors (LRT)

Pilot Study of Lattice Radiotherapy in Adults With Large Tumors

The purpose of this study is to ask whether using a specialized radiation therapy technique called Lattice Radiation Therapy (LRT) can shrink large tumors when given with palliative radiation therapy. The primary questions are:

• if LRT is safe and does not worsen existing side effects or cause new side effects
• if adding LRT to standard radiation therapy can improve tumor shrinkage. Participants will have one additional radiation treatment (LRT) prior to starting palliative radiation and then their progress will be followed for one year.

Study Overview

• Status: Not yet recruiting
• Conditions: Palliative Radiotherapy; Large Tumor
• Intervention / Treatment: Radiation: Lattice Radiation Therapy (LRT)

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Franklin, RN BSN OCN; Phone Number: 919-668-3726; Email: heather.mccullough@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Center
      • Principal Investigator: Trey Mullikin, MD
      • Contact: Duke Radiation Oncology Clinical Trials; Phone Number: 919-668-3726; Email: RadOnc-Clinical_Trials@dm.duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed malignancy diagnosis
• Radiographic evidence of large extracranial tumor (≥ 4.5 cm)
• Patients with primary or metastatic extracranial tumors may be included
• Planned to undergo palliative radiation treatment
• Life expectancy of at least 3 months
• ECOG performance status ≤ 3
• Patient must sign study-specific informed consent

Exclusion Criteria:

• Primary lesion with radiosensitive histology (i.e. germ cell tumors, lymphoma, leukemia, and multiple myeloma)
• Prior radiation treatment that overlaps with any planned site of protocol radiotherapy that would preclude further palliative RT.
• Receiving concurrent cytotoxic cancer therapy regimens or VEGF inhibitor that would overlap with LRT administration. Cytotoxic chemotherapy, targeted therapies, small molecule inhibitors, or sVEGF inhibitors prior to radiation treatment or planned after radiation delivery are allowed at the discretion of the treating radiation oncologist.

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); Participants will receive one additional dose of Intensity-Modulated Radiation Therapy (IMRT) called Lattice Radiation Therapy (LRT) prior to starting regular palliative radiation therapy.	Radiation: Lattice Radiation Therapy (LRT); Lattice Radiation Therapy (LRT) is a specialized form of Intensity-Modulated Radiation Therapy (IMRT) designed to provide focused radiation to the deepest part of large tumors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Radiotherapy (RT) treatment-related, non-hematologic CTCAE v6.0 Grade ≥ 3 toxicity and Adverse Events of Special Interest (AESI) at 90 days	Incidence reported as the number of events divided by the study population.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Radiotherapy (RT) treatment-related, non-hematologic CTCAE v6.0 Grade ≥ 3 toxicity and Adverse Events of Special Interest (AESI) at 12 months	Incidence reported as the number of events divided by the study population.	12 months
Tumor response as measured by change in volume		3 months, 6 months, 12 months
Tumor response as measured by change in largest dimension (maximal diameter)		3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Trey Mullikin, MD, Duke Health

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: large tumor; palliative radiation therapy; lattice radiation therapy (LRT)
• Other Study ID Numbers: Pro00120554

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