A Phase 3 interventional study of Conventional Radiation Therapy and Spatially fractionated radiation therapy in Histopathologically or Cytologically Confirmed Solid Tumor Who Require Palliation Radiation Therapy to a Lesion ≥5cm, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by University Health Network, Toronto · Phase 3, Interventional, and Treatment
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.
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.
University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Homogenous RT (20Gy to 35Gy in 5 fractions), planned using volumetric modulated arc therapy or 3D conformal radiotherapy (3DCRT)
Radiation: Conventional Radiation Therapy
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
Radiation: Spatially fractionated radiation therapy
Delivered using simple techniques and includes dose prescriptions of: 8Gy in 1 fraction, 20Gy in 5 fractions, and 30Gy in 10 fractions
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.
Also known as: LATTICE, LRT, SFRT
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.
Time frame: 30 +/- 7 days after treatment
Pain response pattern
Measured using ICPRE
Time frame: 1, 3, and 6 months post RT
Reirradiation rate
Measured by counting the number of patients receiving reirradiation
Time frame: 6 months following radiotherapy
Treatment-related toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v5
Time frame: at baseline, after treatment, and at 1, 3 and 6 months after treatment
Objective tumour response
Measured using RECIST with the CT scans
Time frame: Baseline and at 3 and 6 months post-treatment
Overall survival
Overall survival (OS): time alive following treatment
Time frame: 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
Time frame: measured from randomization to progression at any site (until 6 month follow up post RT) or death
Plan to share: Undecided
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University Health Network, Toronto