Recruiting
Phase 3

SFRT vs. RT

Sponsor:

University Health Network, Toronto

Code:

NCT07444775

Conditions

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

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Conventional Radiation Therapy

Spatially fractionated radiation therapy

Study Details

Brief 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. 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.

Conditions

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

Study ID

NCT07444775

Start date

Nov 18, 2025

Status verified date

Feb, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

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

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A "Conventional Radiation Therapy"

Homogenous RT (20Gy to 35Gy in 5 fractions), planned using volumetric modulated arc therapy or 3D conformal radiotherapy (3DCRT)

experimental: Arm B "Lattice 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

Interventions

Conventional Radiation Therapy

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

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.

Primary outcome measure

  • Response in pain [ Time Frame: 30 +/- 7 days after treatment ]

Central Contacts and Locations

Central contacts

Jelena Lukovic, MD FRCPC MPH MRMD

416 946 4483Jelena.lukovic@uhn.ca

Locations

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Principal Investigator:

Jelena Lukovic, MD FRCPC MPH MRMD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Keywords

  • Lattice Radiation Therapy
  • Conventional Radiation Therapy
  • Spatially fractionated radiation therapy
  • SFRT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-03.