Large TumorLRTNCT07647679
Lattice Radiotherapy for Adults With Large Tumors
A study testing Lattice Radiation Therapy (LRT) in people with Large Tumor and Palliative Radiotherapy, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Tumor, Palliative Radiotherapy
- What is being tested?
- Lattice Radiation Therapy (LRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke Cancer Center
Durham, North Carolina, 27710
Duke Radiation Oncology Clinical Trials, 919-668-3726, RadOnc-Clinical_Trials@dm.duke.edu
Trey Mullikin, MD
About this study
Official title: 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.
- Conditions
- Large Tumor, Palliative Radiotherapy
- Being tested
- Lattice Radiation Therapy (LRT)
- Keywords
- palliative radiation therapy, large tumor, lattice radiation therapy (LRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Lattice Radiation Therapy (LRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Incidence reported as the number of events divided by the study population.
Measured: 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
Incidence reported as the number of events divided by the study population.
Measured: 12 months
Tumor response as measured by change in volume
Measured: 3 months, 6 months, 12 months
Tumor response as measured by change in largest dimension (maximal diameter)
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large TumorStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trey Mullikin, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647679
- Sponsor's protocol ID
- Pro00120554
- Acronym
- LRT
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Lattice Radiotherapy in Adults With Large Tumors
- ClinicalTrials.gov ID
- NCT07647679
- Acronym / sponsor ID
- LRT / Pro00120554
- Conditions
- Large Tumor, Palliative Radiotherapy
- Keywords
- palliative radiation therapy, large tumor, lattice radiation therapy (LRT)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lattice Radiation Therapy (LRT) | Experimental | Radiation: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Lattice Radiation Therapy (LRT) |
Primary outcome
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.
3 secondary outcomes
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
Tumor response as measured by change in volume
Time frame: 3 months, 6 months, 12 months
Tumor response as measured by change in largest dimension (maximal diameter)
Time frame: 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trey Mullikin, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lattice Radiation Therapy (LRT) in people with Large Tumor and Palliative Radiotherapy, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Franklin, RN BSN OCN (919-668-3726, heather.mccullough@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.