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NCT Number: NCT07647679

Lattice Radiotherapy for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location contact

Duke Radiation Oncology Clinical Trials

CONTACT

[email protected]

919-668-3726

Trey Mullikin, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Eastern Cooperative Oncology Group (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 Vascular Endothelial Growth Factor (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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Radiotherapy (RT) treatment-related, non-hematologic Common Terminology Criteria for Adverse Events (CTCAE) v6.0 Grade ≥ 3 toxicity and Adverse Events of Special Interest (AESI) at 90 days

    Time frame: 90 days

    Incidence reported as the number of events divided by the study population.

Secondary outcomes

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

    Time frame: 12 months

    Incidence reported as the number of events divided by the study population.

  2. Tumor response as measured by change in volume

    Time frame: 3 months, 6 months, 12 months

  3. Tumor response as measured by change in largest dimension (maximal diameter)

    Time frame: 3 months, 6 months, 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Franklin, RN BSN OCN

CONTACT

[email protected]

919-668-3726

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Pilot Study of Lattice Radiotherapy in Adults With Large Tumors

Acronym: LRT

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 15, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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