Histopathologically or Cytologically Confirmed Solid Tumor Who Require Palliation Radiation Therapy to a Lesion ≥5cmPhase 3LATTICE-PALNCT07444775
Lattice Radiation Therapy Versus Conventional Radiation Therapy for the Palliation of Large Tumors
A Phase 3 study testing Conventional Radiation Therapy and Spatially fractionated radiation therapy in people with Histopathologically or Cytologically Confirmed Solid Tumor Who Require Palliation Radiation Therapy to a Lesion ≥5cm, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The goal of this randomized, phase III trial is to to determine if Spatially Fractionated Lattice Radiotherapy (SFRT) known as LATTICE therapy, leads to a greater reduction in pain or discomfort compared with conventional Radiation Therapy (RT) in patients with large tumours. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Histopathologically or Cytologically Confirmed Solid Tumor Who Require Palliation Radiation Therapy to a Lesion ≥5cm
- What is being tested?
- Conventional Radiation Therapy and Spatially fractionated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteCanada
- Study dates
- 18 Nov 2025to Jan 2028
- Phase
- Phase 3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of solid tumor by at least one criterion below:
- Pathologically or cytologically proven solid tumor greater than 5 cm (largest dimension) from a primary site or site of metastasis and unsuitable for surgical resection or definitive RT. b. HCC diagnosed by standard imaging criteria permitted: arterial enhancement and delayed washout on multiphasic computerized tomography (CT) or magnetic resonance imaging (MRI) in the setting of cirrhosis or chronic hepatitis B or C without cirrhosis
- Eastern Cooperative Oncology Group (ECOG) Status: 0-4 within 14 days of randomization
- In the investigator's opinion, patient requires palliative radiation therapy to a lesion >5 cm measured in one of the following ways:
- Imaging performed within 90 days prior to randomization per Response Evaluation Criteria in Solid Tumors (RECIST)
- CT simulation performed for radiation planning
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- Able to understand and provide written consent
- Willing and have the ability to complete the baseline and post-treatment questionnaires (short form brief-pain inventory) and to maintain a pain diary
- Patient is not pregnant, planning on becoming pregnant or planning on fathering a child in the next 90 days
- Patient must be accessible for treatment and follow-up. Investigators must ensure the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
- Minimum worst pain score of 2/10 in the past 24 hours on the Brief Pain Inventory.
Who cannot join
- Prior radiotherapy that would result in substantial overlap of the irradiated volume thus precluding per protocol treatment
- Requirement for urgent surgical intervention prior to radiation treatment
- Confirmed pregnancy
- Hematologic primary malignancy
- Medical condition precluding the delivery of per protocol treatment (e.g. connective tissue disorder)
- Tumors overlying critical CNS, heart or spinal cord compression
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Jelena Lukovic, MD FRCPC MPH MRMD
About this study
The goal of this randomized, phase III trial is to to determine if Spatially Fractionated Lattice Radiotherapy (SFRT) known as LATTICE therapy, leads to a greater reduction in pain or discomfort compared with conventional Radiation Therapy (RT) in patients with large tumours. This is evaluated by assessing if a greater proportion of patients who receive RT with SFRT will have an improvement in pain/discomfort at 30 days defined using the International Consensus Pain Response (ICPR) compared with those treated with conventional RT.
Read the detailed description
This study aims to compare the pain scores of patients receiving conventional radiotherapy and spatially fractionated lattice radiotherapy (SFRT). About half of all cancer patients will undergo palliative radiotherapy (RT) during their illness to manage distressing symptoms such as pain and bleeding. Great and more durable pain responses have been observed with higher dose RT, including stereotactic body radiation therapy (SBRT). Unfortunately, it is not possible to treat large tumors with SBRT for several reasons. SFRT is an innovative RT technique that addresses some of the limitations of SBRT. SFRT uses very high doses of radiation on specific spots inside the tumour, creating a lattice-like pattern. The outer edges of the tumor get a much lower dose, which helps protect nearby healthy organs from radiation. Early phase studies have shown excellent response rates in terms of pain as well as dramatic and rapid resolution of large tumours. Similar results with high responses and low toxicity have been reported in the setting of locally advanced and bulky lung cancer, head and neck cancer, and cervical cancer. This study determines if SFRT leads to a greater reduction in pain or discomfort compared with conventional radiation therapy (RT), defined using the International Consensus for Pain Response (ICPR) which includes the short form Brief Pain inventory questionnaire and self-reporting of opioid and/or co-analgesic use, measured at 30 +/- 7 days following treatment. Pain is defined by a worst pain score of 2 or greater at the target site on the short form Brief pain inventory, within 7 days prior to randomization. The primary endpoint of this study is improvement in pain response with secondary endpoints including treatment-related toxicity above grade 2, objective tumor response, survival, and health-economics endpoints.
- Being tested
- Conventional Radiation Therapy, Spatially fractionated radiation therapy
- Keywords
- Lattice Radiation Therapy, Conventional Radiation Therapy, Spatially fractionated radiation therapy, SFRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Radiation TherapyRadiation
Delivered using simple techniques and includes dose prescriptions of: 8Gy in 1 fraction, 20Gy in 5 fractions, and 30Gy in 10 fractions
Spatially fractionated radiation therapyRadiation
Also called LATTICE, LRT, SFRT
LRT delivers ablative doses to discrete vertices within a tumor, forming a "lattice" while restricting the periphery of the tumor to a safe, low dose thereby minimizing radiation exposure to nearby OAR.
| Study group | Role | What they receive |
|---|---|---|
| Arm A "Conventional Radiation Therapy" | Experimental | Homogenous RT (20Gy to 35Gy in 5 fractions), planned using volumetric modulated arc therapy or 3D conformal radiotherapy (3DCRT) Receives: Radiation: Conventional Radiation Therapy |
| Arm B "Lattice Radiation Therapy" | Experimental | Spatially fractionated radiation therapy, via LATTICE Radiotherapy (LRT), 20Gy in 5 fractions with boost of 67Gy in 5 fractions with boost of 67Gy in 5 fractions to discrete sub-volumes within a tumour Receives: Radiation: Spatially fractionated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response in pain
The primary outcome measure is the proportion of patients achieving a complete response in pain per the ICPR at 30 +/- 7 days after treatment.
Measured: 30 +/- 7 days after treatment
Secondary outcomes (6)
Pain response pattern
Measured using ICPRE
Measured: 1, 3, and 6 months post RT
Reirradiation rate
Measured by counting the number of patients receiving reirradiation
Measured: 6 months following radiotherapy
Treatment-related toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v5
Measured: at baseline, after treatment, and at 1, 3 and 6 months after treatment
Objective tumour response
Measured using RECIST with the CT scans
Measured: Baseline and at 3 and 6 months post-treatment
Overall survival
Overall survival (OS): time alive following treatment
Measured: Measured from randomization to date of death or last follow up (6 months post RT)
Progressive-free survival (PFS)
Progressive-free survival (PFS): time to progression or death
Measured: measured from randomization to progression at any site (until 6 month follow up post RT) or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start18 Nov 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histopathologically or Cytologically Confirmed Solid Tumor Who Require Palliation Radiation Therapy to a Lesion ≥5cmStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444775
- Sponsor's protocol ID
- 24-6019
- Acronym
- LATTICE-PAL
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lattice Radiation Therapy Versus Conventional Radiation Therapy for the Palliation of Large Tumors
- ClinicalTrials.gov ID
- NCT07444775
- Acronym / sponsor ID
- LATTICE-PAL / 24-6019
- Keywords
- Lattice Radiation Therapy, Conventional Radiation Therapy, Spatially fractionated radiation therapy, SFRT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 3 Mar 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 goal of this randomized, phase III trial is to to determine if Spatially Fractionated Lattice Radiotherapy (SFRT) known as LATTICE therapy, leads to a greater reduction in pain or discomfort compared with conventional Radiation Therapy (RT) in patients with large tumours. This is evaluated by assessing if a greater proportion of patients who receive RT with SFRT will have an improvement in pain/discomfort at 30 days defined using the International Consensus Pain Response (ICPR) compared with those treated with conventional RT.
Detailed description
This study aims to compare the pain scores of patients receiving conventional radiotherapy and spatially fractionated lattice radiotherapy (SFRT). About half of all cancer patients will undergo palliative radiotherapy (RT) during their illness to manage distressing symptoms such as pain and bleeding. Great and more durable pain responses have been observed with higher dose RT, including stereotactic body radiation therapy (SBRT). Unfortunately, it is not possible to treat large tumors with SBRT for several reasons. SFRT is an innovative RT technique that addresses some of the limitations of SBRT. SFRT uses very high doses of radiation on specific spots inside the tumour, creating a lattice-like pattern. The outer edges of the tumor get a much lower dose, which helps protect nearby healthy organs from radiation. Early phase studies have shown excellent response rates in terms of pain as well as dramatic and rapid resolution of large tumours. Similar results with high responses and low toxicity have been reported in the setting of locally advanced and bulky lung cancer, head and neck cancer, and cervical cancer. This study determines if SFRT leads to a greater reduction in pain or discomfort compared with conventional radiation therapy (RT), defined using the International Consensus for Pain Response (ICPR) which includes the short form Brief Pain inventory questionnaire and self-reporting of opioid and/or co-analgesic use, measured at 30 +/- 7 days following treatment. Pain is defined by a worst pain score of 2 or greater at the target site on the short form Brief pain inventory, within 7 days prior to randomization. The primary endpoint of this study is improvement in pain response with secondary endpoints including treatment-related toxicity above grade 2, objective tumor response, survival, and health-economics endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A "Conventional Radiation Therapy" | Experimental | Radiation: Conventional Radiation TherapyHomogenous RT (20Gy to 35Gy in 5 fractions), planned using volumetric modulated arc therapy or 3D conformal radiotherapy (3DCRT) |
| Arm B "Lattice Radiation Therapy" | Experimental | Radiation: Spatially fractionated radiation therapySpatially fractionated radiation therapy, via LATTICE Radiotherapy (LRT), 20Gy in 5 fractions with boost of 67Gy in 5 fractions with boost of 67Gy in 5 fractions to discrete sub-volumes within a tumour |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of solid tumor by at least one criterion below:
- Eastern Cooperative Oncology Group (ECOG) Status: 0-4 within 14 days of randomization
- In the investigator's opinion, patient requires palliative radiation therapy to a lesion >5 cm measured in one of the following ways:
- Imaging performed within 90 days prior to randomization per Response Evaluation Criteria in Solid Tumors (RECIST)
- CT simulation performed for radiation planning
Key exclusion criteria (6 listed)
- Prior radiotherapy that would result in substantial overlap of the irradiated volume thus precluding per protocol treatment
- Requirement for urgent surgical intervention prior to radiation treatment
- Confirmed pregnancy
- Hematologic primary malignancy
- Medical condition precluding the delivery of per protocol treatment (e.g. connective tissue disorder)
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 |
|---|---|---|
| Conventional Radiation TherapyDelivered using simple techniques and includes dose prescriptions of: 8Gy in 1 fraction, 20Gy in 5 fractions, and 30Gy in 10 fractions | Radiation | Arm A "Conventional Radiation Therapy" |
| Spatially fractionated radiation therapyAlso: LATTICE, LRT, SFRTLRT delivers ablative doses to discrete vertices within a tumor, forming a "lattice" while restricting the periphery of the tumor to a safe, low dose thereby minimizing radiation exposure to nearby OAR. | Radiation | Arm B "Lattice Radiation Therapy" |
Primary outcome
Response in pain
Time frame: 30 +/- 7 days after treatment
The primary outcome measure is the proportion of patients achieving a complete response in pain per the ICPR at 30 +/- 7 days after treatment.
6 secondary outcomes
Pain response pattern
Time frame: 1, 3, and 6 months post RT
Reirradiation rate
Time frame: 6 months following radiotherapy
Treatment-related toxicity
Time frame: at baseline, after treatment, and at 1, 3 and 6 months after treatment
Objective tumour response
Time frame: Baseline and at 3 and 6 months post-treatment
Overall survival
Time frame: Measured from randomization to date of death or last follow up (6 months post RT)
Progressive-free survival (PFS)
Time frame: measured from randomization to progression at any site (until 6 month follow up post RT) or death
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 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional Radiation Therapy and Spatially fractionated radiation therapy in people with Histopathologically or Cytologically Confirmed Solid Tumor Who Require Palliation Radiation Therapy to a Lesion ≥5cm, run by University Health Network, Toronto at 1 site in Canada.
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 11 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 16 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jelena Lukovic, MD FRCPC MPH MRMD (416 946 4483, Jelena.lukovic@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response in pain (time frame: 30 +/- 7 days after treatment). 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 16 Sep 2026.