A study testing a more precise type of radiotherapy for cancer to reduce pain or discomfort
| ISRCTN | ISRCTN73938525 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73938525 |
| Protocol serial number | 24-6019 |
| Sponsor | University Health Network |
| Funder | Investigator initiated and funded |
- Submission date
- 14/11/2025
- Registration date
- 18/11/2025
- Last edited
- 17/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
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.
Who can participate?
Patients aged 18 years and over diagnosed with solid tumour and requiring radiation to a lesion greater than 5 cm
What does the study involve?
Once enrolled in the study, the patients will be randomly allocated to one of two treatments: conventional radiotherapy or lattice radiotherapy. All patients will receive their dose in five fractions. At baseline, post-treatment and 1, 3, and 6 months follow-up visits, they will be asked about their pain level and which pain medication they are taking.
What are the possible benefits and risks of participating?
The benefits of participating may be that patients may have an improved pain response. However, it is not certain at the moment. The risks of participating are very similar to the risks of a person receiving conventional radiotherapy. This can include symptoms in correlation to the treatment area. Radiotherapy has a risk of tumor lysis syndrome (TLS), which may be elevated with lattice radiotherapy.
Where is the study run from?
Princess Margaret Cancer Centre (Canada)
When is the study starting and how long is it expected to run for?
November 2025 to January 2028
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Jelena Lukovic, jelena.lukovic@uhn.ca
Contact information
Public, Scientific, Principal investigator
700 University Avenue
Toronto
M5G 1Z5
Canada
| Phone | +1 (0)416 946 4483 |
|---|---|
| jelena.lukovic@uhn.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase III single-site two-arm interventional randomized trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Lattice Radiation Therapy versus Conventional Radiation Therapy for the Palliation of Large Tumors |
| Study acronym | LATTICE-PAL |
| Study objectives | Primary objective: determine if treatment with spatially fractionated radiation therapy (LRT) leads to a greater proportion of patients achieving a complete response in pain/discomfort at 30 days, measured with the international consensus pain response (ICPR), compared with standard conventional RT. Secondary objectives: 1. Pain response pattern at 1,3, and 6 months: complete, partial, stable or progressive pain 2. Re-irradiation rate within the 6-month follow-up period 3. Incidence of treatment-related toxicity rates > Grade 2 4. Imaging-based tumor response rates at 3 and 6 months post treatment 5. Local control, progression-free survival (PFS) and overall survival (OS) |
| Ethics approval(s) |
Approved 16/10/2025, University Health Network Research Ethics Board (700 University Ave. 4th Floor, Toronto, M5G 1Z5, Canada; +1 (0)416 581 7849; reb@uhnresearch.ca), ref: 24-6019 |
| Health condition(s) or problem(s) studied | Solid tumour |
| Intervention | Lattice Radiation Therapy: Spatially fractionated radiation therapy, via LATTICE Radiotherapy (LRT) in five fractions to discrete sub-volumes within a tumor Once enrolled in the study, the patients will be randomly allocated using REDCap to one of two treatments: conventional radiotherapy or lattice radiotherapy. All patients will receive their dose in five fractions. At baseline, post-treatment and 1, 3, and 6 months follow-up visits, they will be asked about their pain level and which pain medication they are taking. |
| Intervention type | Device |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Lattice radiation therapy and conventional radiation therapy |
| Primary outcome measure(s) |
Pain is measured using international consensus for pain response (ICPR) at baseline and 30 +/-7 days following treatment |
| Key secondary outcome measure(s) |
1. Pain response pattern measured using ICPRE at 1, 3, and 6 months post RT |
| Completion date | 01/01/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 148 |
| Key inclusion criteria | 1. Diagnosis of solid tumor by at least one criterion below: 1.1. 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 1.2. 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 2. Eastern Cooperative Oncology Group (ECOG) Status: 0-4 within 14 days of randomization 3. In the investigator’s opinion, patient requires palliative radiation therapy to a lesion >5 cm measured in one of the following ways: 3.1. Imaging performed within 90 days prior to randomization per Response Evaluation Criteria in Solid Tumors (RECIST) 3.2. CT simulation performed for radiation planning 4. Able to understand and provide written consent 5. Willing and have the ability to complete the baseline and post-treatment questionnaires (short form brief-pain inventory) and to maintain a pain diary 6. Patient is not pregnant, planning on becoming pregnant or planning on fathering a child in the next 90 days 7. 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 |
| Key exclusion criteria | 1. Prior radiotherapy that would result in substantial overlap of the irradiated volume thus precluding per protocol treatment 2. Requirement for urgent surgical intervention prior to radiation treatment 3. Confirmed pregnancy 4. Hematologic primary malignancy 5. Medical condition precluding the delivery of per protocol treatment (e.g. connective tissue disorder) 6. Tumors overlying critical CNS, heart or spinal cord compression |
| Date of first enrolment | 19/11/2025 |
| Date of final enrolment | 01/07/2027 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto
M5G 2C4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
17/11/2025: Study's existence confirmed by the University Health Network Research Ethics Board.
