Comparing Conventional Radiation Therapy with Spatially fractionated radiation therapy for histopathologically or cytologically confirmed solid tumor
Official title: Lattice Radiation Therapy Versus Conventional Radiation Therapy for the Palliation of Large Tumors
- Phase 3
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Radiation therapy
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
- Radiation therapy
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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Princess Margaret Cancer Center
Toronto, Ontario
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Eastern Cooperative Oncology Group (ECOG) Status: 0-4 within 14 days of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- +a. Pathologically or cytologically proven solid tumor greater than 5 cm (largest dimension) from a primary siteTrial siteA hospital or clinic where a study is actually run.Read more → or site of metastasis and unsuitable for surgical resection or definitive RT. b. HCC diagnosed by standard imaging criteria permitted: arterial enhancement and delayed washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → on multiphasic computerized tomography (CT) or magnetic resonance imaging (MRI) in the setting of cirrhosis or chronic hepatitis B or C without cirrhosis
- +Diagnosis of solid tumor by at least one criterion below:
- +Imaging performed within 90 days prior to randomization per Response Evaluation Criteria in Solid Tumors (RECIST)
- +Able to understand and provide written consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Willing and have the ability to complete the baselineBaselineYour starting measurements, taken before treatment begins.Read more → and post-treatment questionnaires (short form brief-pain inventory) and to maintain a pain diary
- +Patient must be accessible for treatment and follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →. Investigators must ensure the patients randomized on this trial will be available for complete documentation of the treatment, adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →, and follow-up
- +Patient is not pregnant, planning on becoming pregnant or planning on fathering a child in the next 90 days
- +In the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, patient requires palliative radiation therapy to a lesion \>5 cm measured in one of the following ways:
- +CT simulation performed for radiation planning
Exclusion
- −Prior radiotherapy that would result in substantial overlap of the irradiated volume thus precluding per protocolProtocolThe detailed plan a study must follow.Read more → treatment
- −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
- −Confirmed pregnancy
- −Requirement for urgent surgical intervention prior to radiation treatment
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Conventional Radiation Therapy.
Registry label: A: Arm A "Conventional Radiation Therapy"
Group B receives Spatially fractionated radiation therapy.
Registry label: B: Arm B "Lattice Radiation Therapy"
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 99 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 148 people.
The study is currently expected to finish around January 2028.
The main measurement is taken over: 30 +/- 7 days after treatment.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Response in pain — measured over 30 +/- 7 days after treatment.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07444775 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Conventional Radiation TherapyRadiation
Delivered using simple techniques and includes dose prescriptions of: 8Gy in 1 fraction, 20Gy in 5 fractions, and 30Gy in 10 fractions
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About Spatially fractionated radiation therapyRadiation
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.
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 99 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 99 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 30 +/- 7 days after treatment.
The study as a whole is currently expected to finish around 2028-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 148 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.