Comparing Radiation Therapy with Hypofractionated Radiation Therapy for lung cancers
Official title: An Evaluation of Dose-escalation for Intrathoracic Tumours
A Phase II/III Randomized Evaluation of Dose-escalation With Esophageal-sparing for Palliation of Intrathoracic Tumours (PREVENT)
- 2 groups
- Sites in Kelowna, London and 1 more city
- Recruiting
Interventions
- Radiation therapy
Hypofractionated Radiation Therapy
Hypofractionated, dose-escalated, esophageal-sparing intensity modulated radiation therapy
- Radiation therapy
Radiation Therapy
standard of care palliative thoracic radiotherapy using volumetric modulated arc therapy/intensity-modulating radiotherapy
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
British Columbia Cancer Agency Center for the Southern Interior
Kelowna, British Columbia
- Recruiting
London Health Sciences Center Research Institute (Formerly Lawson Research Institute)
London, Ontario
- Recruiting
Waterloo Regional Health Network
Waterloo, Ontario
Eligibility Criteria
See who this study is looking for11 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 performance status 0-3
- +Willingness and ability to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Age 18 years or older
- +Life expectancy greater than 3 months
- +Intrathoracic tumour requiring palliative radiation, either for palliation of symptoms or prevention of progression that is expected to cause symptoms in the next 6 months (in the judgement of the enrolling investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →)
- +Prior or planned systemic treatment (chemotherapy, immunotherapy, targeted agents) is permissible at the discretion of the treating medical oncologist
- +Concurrent palliative radiotherapy to other metastatic sites is permissible at the discretion of the treating radiation oncologist.
Exclusion
- −Inability to attend the full course of radiotherapy or planned follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → visits
- −Pregnant or lactating women
- −Prior thoracic radiotherapy which, in the opinion of the treating of radiation oncologist, precludes the delivery of further thoracic radiotherapy. If there has been prior thoracic radiotherapy, a composite of all RT plans must be created, and the dose constraints herein must still be met. An allowance for 10 percent repair is permitted if at least 12 months have passed between the prior radiotherapy and the trial protocolProtocolThe detailed plan a study must follow.Read more → specified radiotherapy.
- −Serious medical comorbidities which, in the opinion of the treating radiation oncologist, preclude the delivery of radiotherapy. This includes interstitial lung disease.
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.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
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, the comparison group, receives Radiation Therapy.
Registry label: A: Standard Radiotherapy
Group B receives Hypofractionated Radiation Therapy.
Registry label: B: Experimental Radiotherapy
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.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
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.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 141 people.
The study is currently expected to finish around March 2029.
The main measurement is taken over: from enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → until 36 months post radiotherapy.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
time to definitive quality of life deterioration or death — measured over from enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → until 36 months post radiotherapy.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06794125 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 Hypofractionated Radiation TherapyRadiation
Hypofractionated, dose-escalated, esophageal-sparing intensity modulated radiation therapy
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 Radiation TherapyRadiation
standard of care palliative thoracic radiotherapy using volumetric modulated arc therapy/intensity-modulating radiotherapy
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: a minimum age of 18 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.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
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 a minimum age of 18 years, with no upper limit given.
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.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: from enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → until 36 months post radiotherapy.
The study as a whole is currently expected to finish around 2029-03-01.
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 141 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Kelowna, British Columbia, Canada; London, Ontario, Canada; Waterloo, 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
This is a pragmatic trial with patients randomized between standard of care palliative thoracic radiation therapy (RT) vs. hypofractionated, dose-escalated, esophageal-sparing (HD-ES) intensity modulated radiation therapy (IMRT). The investigators hypothesize that the use of advanced radiation planning techniques to optimize dose to esophagus will permit the safe delivery of a modestly dose-escalated five-fraction course of palliative radiation to intrathoracic malignancies. This approach aims to deliver higher biologically effective doses while improving toxicity when compared to conventional approaches with the goal of prolonging high-quality overall survival.
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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.