NCT07444775 Lattice Radiation Therapy Versus Conventional Radiation Therapy for the Palliation of Large Tumors
| NCT ID | NCT07444775 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Health Network, Toronto |
| Condition | Histopathologically or Cytologically Confirmed Solid Tumor Who Require Palliation Radiation Therapy to a Lesion ≥5cm |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2025-11-18 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 148 participants in total. It began in 2025-11-18 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07444775 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Histopathologically or Cytologically Confirmed Solid Tumor Who Require Palliation Radiation Therapy to a Lesion ≥5cm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07444775 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 148 participants.
Is NCT07444775 currently recruiting?
Yes, NCT07444775 is actively recruiting participants. Contact the research team at Jelena.lukovic@uhn.ca for enrollment information.
Where is the NCT07444775 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07444775 clinical trial?
NCT07444775 is sponsored by University Health Network, Toronto. The trial plans to enroll 148 participants.