Lattice Radiotherapy for Adults With Large Tumors

NCT07647679 | Not Yet Recruiting

• 1 other identifier: Pro00120554
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Large Tumor; Palliative Radiotherapy

Keywords

palliative radiation therapy; large tumor; lattice radiation therapy (LRT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of Radiotherapy (RT) treatment-related, non-hematologic CTCAE v6.0 Grade ≥ 3 toxicity and Adverse Events of Special Interest (AESI) at 12 months

  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

Study Arms (1)

Lattice Radiation Therapy (LRT)

EXPERIMENTAL

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)

Interventions

Lattice Radiation Therapy (LRT) RADIATION

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.

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:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Trey Mullikin, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Franklin, RN BSN OCN

CONTACT

919-668-3726; heather.mccullough@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)