MetastasesPhase 2NCT07594431
Trial Comparing LATTICE Radiotherapy vs Moderately Dose-escalated Palliative Radiation for Patients With Metastases.
A Phase 2 study testing LATTICE Radiotherapy and Standard radiotherapy in people with Metastases and Metastatic Cancer, run by Stanford University at 1 site in United States.
Trial summary
Unblinded, randomized study of 5-fraction LATTICE radiotherapy (20 Gy with an SIB to 66.7 Gy in 5 fractions) versus moderately dose-escalated palliative radiation (25 Gy in 5 fractions) Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Metastases, Metastatic Cancer
- What is being tested?
- LATTICE Radiotherapy and Standard radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2026to Aug 2028
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer
- One to two metastases in non-brain sites that are amenable to LATTICE radiotherapy: >2.5 cm in short axis (dimension on axial imaging that is perpendicular to the longest dimension); bone metastasis can be included if the extraosseous component is >2.5 cm in short axis
- Age ≥12
- ECOG Performance Status 0-2
- For patients age 12-16, Lansky Play-Performance score 50-100
- Negative serum or urine pregnancy test within 2 weeks prior to enrollment of people of childbearing potential
- All patients and/or their parents or legal guardians must sign a written informed consent. For any child less than 18 years of age, assent must also be obtained in addition to parental or legal guardian consent.
Who cannot join
- Prior radiation therapy to the tumor to be treated
- Active pregnancy
- Diseases that place the patient at high risk of radiation complications including lupus, scleroderma, Li Fraumeni syndrome
- The tumor to be treated is from a hematologic malignancy such as lymphoma or myeloma
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, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94304
Jamie Wong, 650-497-4354, jwang97@stanford.edu
Camellia Djebroun, 650-736-5564, cdjebrou@stanford.edu
About this study
Official title: A Randomized Phase II Trial Comparing LATTICE Radiotherapy vs Moderately Dose-escalated Palliative Radiation for Patients With Metastases.
Unblinded, randomized study of 5-fraction LATTICE radiotherapy (20 Gy with an SIB to 66.7 Gy in 5 fractions) versus moderately dose-escalated palliative radiation (25 Gy in 5 fractions)
- Conditions
- Metastases, Metastatic Cancer
- Being tested
- LATTICE Radiotherapy, Standard radiotherapy
- Keywords
- LATTICE Radiotherapy, Palliative Radiotherapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LATTICE RadiotherapyRadiation
5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
Standard radiotherapyRadiation
Standard radiotherapy delivered to 25 Gy in 5 fractions.
| Study group | Role | What they receive |
|---|---|---|
| LATTICE Radiotherapy | Experimental | Participants receive 5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. Receives: Radiation: LATTICE Radiotherapy |
| Standard Radiotherapy | Active comparator | Participants receive standard radiotherapy (25 Gy in 5 fractions) Receives: Radiation: Standard radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Tumor Volume Reduction Following Radiotherapy
Radiographic response defined as percent tumor volume reduction 90 +/- 20 days following radiotherapy
Measured: 90 +/- 20 days following radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start28 Aug 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetastasesStudies of the same condition, open and under way.
- More trials run by Stanford 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Gensheimer, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594431
- Sponsor's protocol ID
- IRB-86384
- Status last verified
- Sep 2026
- First submitted
- 12 May 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial Comparing LATTICE Radiotherapy vs Moderately Dose-escalated Palliative Radiation for Patients With Metastases.
- ClinicalTrials.gov ID
- NCT07594431
- Acronym / sponsor ID
- IRB-86384
- Conditions
- Metastases, Metastatic Cancer
- Keywords
- LATTICE Radiotherapy, Palliative Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 18 May 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.
Unblinded, randomized study of 5-fraction LATTICE radiotherapy (20 Gy with an SIB to 66.7 Gy in 5 fractions) versus moderately dose-escalated palliative radiation (25 Gy in 5 fractions)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LATTICE Radiotherapy | Experimental | Radiation: LATTICE RadiotherapyParticipants receive 5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. |
| Standard Radiotherapy | Active comparator | Radiation: Standard radiotherapyParticipants receive standard radiotherapy (25 Gy in 5 fractions) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer
- One to two metastases in non-brain sites that are amenable to LATTICE radiotherapy: >2.5 cm in short axis (dimension on axial imaging that is perpendicular to the longest dimension); bone metastasis can be included if the extraosseous component is >2.5 cm in short axis
- Age ≥12
- ECOG Performance Status 0-2
- For patients age 12-16, Lansky Play-Performance score 50-100
Key exclusion criteria (4 listed)
- Prior radiation therapy to the tumor to be treated
- Active pregnancy
- Diseases that place the patient at high risk of radiation complications including lupus, scleroderma, Li Fraumeni syndrome
- The tumor to be treated is from a hematologic malignancy such as lymphoma or myeloma
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 Radiotherapy5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | Radiation | LATTICE Radiotherapy |
| Standard radiotherapyStandard radiotherapy delivered to 25 Gy in 5 fractions. | Radiation | Standard Radiotherapy |
Primary outcome
Percent Tumor Volume Reduction Following Radiotherapy
Time frame: 90 +/- 20 days following radiotherapy
Radiographic response defined as percent tumor volume reduction 90 +/- 20 days following radiotherapy
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 9 Sep 2026.
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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.
Michael Gensheimer, MD principal investigator
Stanford University
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 Radiotherapy and Standard radiotherapy in people with Metastases and Metastatic Cancer, run by Stanford 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 4 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 9 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.
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 Jamie Wang (650-497-4354, jwang97@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Tumor Volume Reduction Following Radiotherapy (time frame: 90 +/- 20 days following radiotherapy). 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 9 Sep 2026.