RECRUITING Phase 3 ClinicalTrials.gov

Lattice Radiation Therapy Versus Conventional Radiation Therapy for the Palliation of Large Tumors

Sponsor: University Health Network, Toronto • ClinicalTrials.gov ID: NCT07444775

Registry updated: 2026-09-16

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Description

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.

Interventions

Conventional Radiation Therapy (Radiation)
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 therapy (Radiation)
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.

Eligibility criteria

Inclusion Criteria: * 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 * Minimum worst pain score of 2/10 in the past 24 hours on the Brief Pain Inventory. Exclusion Criteria: * 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

Conditions

Histopathologically or Cytologically Confirmed Solid Tumor Who Require Palliation Radiation Therapy to a Lesion ≥5cm

Locations

Princess Margaret Cancer Center — Toronto, Ontario, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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