Lattice Radiation Therapy Versus Conventional Radiation Therapy for the Palliation of Large Tumors
Recruiting now · Phase 3
Conditions studied: Histopathologically or Cytologically Confirmed Solid Tumor Who Require Palliation Radiation Therapy to a Lesion ≥5cm
In brief
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.
Key facts
- Study ID
- NCT07444775
- Run by
- University Health Network, Toronto
- People needed
- 148
- Starts
- 2025-11-18
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of solid tumor by at least one criterion below:
- a. 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
- 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
You may not qualify if…
- 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
Where it is running
- Princess Margaret Cancer Center — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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