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

NCT07444775 | Recruiting Phase 3

• 1 other identifier: 24-6019
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  30 +/- 7 days after treatment

Secondary Outcomes (6)

• Pain response pattern

  1, 3, and 6 months post RT

• Reirradiation rate

  6 months following radiotherapy

• Treatment-related toxicity

  at baseline, after treatment, and at 1, 3 and 6 months after treatment

• Objective tumour response

  Baseline and at 3 and 6 months post-treatment

• Overall survival

  Measured from randomization to date of death or last follow up (6 months post RT)

Study Arms (2)

Arm A "Conventional Radiation Therapy"

EXPERIMENTAL

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

Radiation: Conventional Radiation Therapy

Arm B "Lattice Radiation Therapy"

EXPERIMENTAL

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

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

Arm A "Conventional Radiation Therapy"

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.

Also known as: LATTICE, LRT, SFRT

Arm B "Lattice Radiation Therapy"

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Interventions

GRL1 protein, Tetrahymena thermophila

Central Study Contacts

Jelena Lukovic, MD FRCPC MPH MRMD

CONTACT

416 946 4483; Jelena.lukovic@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: March 3, 2026
• Study Start: November 18, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CA (1)