CancerPhase 2NCT06416007
Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
A Phase 2 study testing Lattice therapy (LRT) in people with Cancer and Metastatic Cancer, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Metastatic Cancer, Locally Advanced
- What is being tested?
- Lattice therapy (LRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2024to 1 Jun 2027
- Phase
- Phase 2
- 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
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andrew Frankart, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Andrew Frankart, MD
About this study
Official title: A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
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.
Read the detailed description
This will be a single-institution, single-arm Phase II trial with an anticipated total of 37 patients enrolled. Treatment will consist of 5 fractions of lattice radiation therapy delivered every other day. The primary endpoints will include the efficacy of lattice therapy as evaluated by ORR (CR or PR per RECIST criteria) at 60 days (2 months) post-treatment and safety. Toxicity will be evaluated at day 5 (+/- 2 days), day 15 (+/- 5 days), day 30 (+/- 5 days), and day 60 (+/- 7 days) post-completion of lattice therapy. This study will also include a translational analysis of the impact of lattice therapy on systemic immune responses.
- Conditions
- Cancer, Metastatic Cancer, Locally Advanced, Locally Advanced Solid Tumor, Locally Advanced Carcinoma
- Being tested
- Lattice therapy (LRT)
- Keywords
- Radiation, Radiotherapy, Bulky, Spatial fractionation, Lattice therapy, Palliative, Palliation
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lattice therapy (LRT)Radiation
5 Fractions LRT
| Study group | Role | What they receive |
|---|---|---|
| Lattice radiation therapy (LRT) | Experimental | Lattice radiation therapy (LRT) : 5 fractions Receives: Radiation: Lattice therapy (LRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days post treatment
Adverse Events
To characterize the safety profile and adverse events (AEs) of lattice therapy.
Measured: Up to 60 days post-treatment
Secondary outcomes (2)
Overall Survival
To assess overall survival (OS) following lattice therapy. Overall survival will be assessed via review of medical and vital records.
Measured: 12 months post treatment
Patient-reported Quality of Life
To determine patient-reported quality of life outcomes after lattice therapy via the Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7) tool as a measure of global quality of life. This is measured on 5 point Likert-type scale ranging from 0-4. Higher scores reflect better QOL.
Measured: 60 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start2 Aug 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Frankart, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416007
- Sponsor's protocol ID
- UCCC-RT-23-01
- Status last verified
- Apr 2026
- First submitted
- 6 May 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
- ClinicalTrials.gov ID
- NCT06416007
- Acronym / sponsor ID
- UCCC-RT-23-01
- Conditions
- Cancer, Metastatic Cancer, Locally Advanced, Locally Advanced Solid Tumor, Locally Advanced Carcinoma
- Keywords
- Radiation, Radiotherapy, Bulky, Spatial fractionation, Lattice therapy, Palliative, Palliation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 16 May 2024 (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 research study is to determine if lattice radiation therapy (LRT) will provide better treatment for bulky (large) tumors than current standard of care radiotherapy.
Detailed description
This will be a single-institution, single-arm Phase II trial with an anticipated total of 37 patients enrolled. Treatment will consist of 5 fractions of lattice radiation therapy delivered every other day. The primary endpoints will include the efficacy of lattice therapy as evaluated by ORR (CR or PR per RECIST criteria) at 60 days (2 months) post-treatment and safety. Toxicity will be evaluated at day 5 (+/- 2 days), day 15 (+/- 5 days), day 30 (+/- 5 days), and day 60 (+/- 7 days) post-completion of lattice therapy. This study will also include a translational analysis of the impact of lattice therapy on systemic immune responses.
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 therapy (LRT)Lattice radiation therapy (LRT) : 5 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 therapy (LRT)5 Fractions LRT | Radiation | Lattice radiation therapy (LRT) |
Primary outcome
Overall Response Rate
Time frame: 60 days post treatment
To evaluate the efficacy of lattice therapy in patients with bulky tumors, as measured by objective response rate (ORR) at 60 days post-treatment.
Adverse Events
Time frame: Up to 60 days post-treatment
To characterize the safety profile and adverse events (AEs) of lattice therapy.
2 secondary outcomes
Overall Survival
Time frame: 12 months post treatment
Patient-reported Quality of Life
Time frame: 60 days post treatment
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 4 May 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.
Andrew Frankart, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lattice therapy (LRT) in people with Cancer and Metastatic Cancer, run by University of Cincinnati 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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 May 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 UCCC Clinical Trials Office (513-584-7698, cancer@uchealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: 60 days post treatment). The study lists 2 primary outcomes in all. 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 4 May 2026.