Lung CancersPREVENT-LUNGNCT06794125
An Evaluation of Dose-escalation for Intrathoracic Tumours
A study testing Hypofractionated Radiation Therapy and Radiation Therapy in people with Lung Cancers, run by Chris Goodman at 4 sites in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancers
- What is being tested?
- Hypofractionated Radiation Therapy and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 4 sitesCanada
- Study dates
- 3 Sep 2025to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 investigator)
- Willingness and ability to provide informed consent
- Eastern Cooperative Oncology Group performance status 0-3
- Age 18 years or older
- 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.
- Life expectancy greater than 3 months
Who cannot join
- 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 protocol specified radiotherapy.
- Serious medical comorbidities which, in the opinion of the treating radiation oncologist, preclude the delivery of radiotherapy. This includes interstitial lung disease.
- Pregnant or lactating women
- Inability to attend the full course of radiotherapy or planned follow-up visits
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
British Columbia Cancer Agency Center for the Southern Interior
Kelowna, British Columbia, V1Y5L3
Thomas Kennedy, MD, 250-717-4272 ext. 250-717-4272, thomas.kennedy@bccancer.bc.ca
Jenny Petterson, 250-717-4272, jennifer.petterson@bccancer.bc.ca
- Recruiting
London Health Sciences Center Research Institute (Formerly Lawson Research Institute)
London, Ontario, N6A 4L6
Chris Goodman, MD, 519-685-8500 ext. 53286, chris.Goodman@lhsc.on.ca
David Palma, MD, 519-685-8500 ext. 56859, david.palma@lhsc.on.ca
- Recruiting
Horizon Health New Brunswick
Saint John, New Brunswick
Carrie Folkins, 506-648-6890, Carrie.Folkins@HorizonNB.ca
Robert Thompson, MD
- Recruiting
Waterloo Regional Health Network
Waterloo, Ontario
Stephanie Nemirov, 519-749-4300 ext. 2447, stephanie.nemirov@wrhn.ca
Sameen Saad, 519-749-4300 ext. 2447, sameen.saad@wrhn.ca
About this study
Official title: A Phase II/III Randomized Evaluation of Dose-escalation With Esophageal-sparing for Palliation of Intrathoracic Tumours (PREVENT)
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.
- Conditions
- Lung Cancers
- Being tested
- Hypofractionated Radiation Therapy, Radiation Therapy
- Keywords
- lung cancer, radiation therapy, hypofractionated, esophageal-sparing, dose-escalated, intrathoracic
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Radiation TherapyRadiation
Hypofractionated, dose-escalated, esophageal-sparing intensity modulated radiation therapy
Radiation TherapyRadiation
standard of care palliative thoracic radiotherapy using volumetric modulated arc therapy/intensity-modulating radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Standard Radiotherapy | Active comparator | 20 Gray in 5 fractions or 30 Gray in 10 fractions. Receives: Radiation: Radiation Therapy |
| Experimental Radiotherapy | Experimental | 35 Gray in 5 fractions Receives: Radiation: Hypofractionated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to definitive quality of life deterioration or death
Defined as time from randomization to the first of:
- deterioration in Functional Assessment of Cancer Therapy: Lung Trial Outcome Index score by greater than or equal to 5 points compared to baseline score and with no subsequent improvement to within 5 points of baseline ii. death iii. last follow-up
Measured: from enrollment until 36 months post radiotherapy
Secondary outcomes (4)
Quality of Life - Patient Reported Outcomes
Measured via Functional Assessment of Cancer Therapy: Lung and EuroQol 5-dimension 5-level
Measured: From enrollment until 36 months post radiotherapy
Toxicity - Adverse Events that happen to a patient during the clinical trial
Defined as incidence of Common Terminology Criteria for Adverse Events version 5 grade 2 and higher toxicity
Measured: From enrollment until 36 months post radiotherapy
Freedom from intrathoracic progression
Defined as time from randomization to disease progression within the thorax, or last follow-up, whichever occurs first
Measured: From enrollment until 36 months post radiotherapy
Overall Survival
Defined as time from randomization to death from any cause, or last follow-up, whichever occurs first
Measured: From enrollment until 36 months post radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start3 Sep 2025
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chris Goodman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chris Goodman, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794125
- Sponsor's protocol ID
- PREVENT-LUNG
- Acronym
- PREVENT-LUNG
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Randomized Evaluation of Dose-escalation With Esophageal-sparing for Palliation of Intrathoracic Tumours (PREVENT)
- ClinicalTrials.gov ID
- NCT06794125
- Acronym / sponsor ID
- PREVENT-LUNG / PREVENT-LUNG
- Conditions
- Lung Cancers
- Keywords
- lung cancer, radiation therapy, hypofractionated, esophageal-sparing, dose-escalated, intrathoracic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Chris GoodmanUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Radiotherapy | Active comparator | Radiation: Radiation Therapy20 Gray in 5 fractions or 30 Gray in 10 fractions. |
| Experimental Radiotherapy | Experimental | Radiation: Hypofractionated Radiation Therapy35 Gray in 5 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 investigator)
- Willingness and ability to provide informed consent
- Eastern Cooperative Oncology Group performance status 0-3
- Age 18 years or older
- Prior or planned systemic treatment (chemotherapy, immunotherapy, targeted agents) is permissible at the discretion of the treating medical oncologist
Key exclusion criteria (4 listed)
- 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 protocol specified radiotherapy.
- Serious medical comorbidities which, in the opinion of the treating radiation oncologist, preclude the delivery of radiotherapy. This includes interstitial lung disease.
- Pregnant or lactating women
- Inability to attend the full course of radiotherapy or planned follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated Radiation TherapyHypofractionated, dose-escalated, esophageal-sparing intensity modulated radiation therapy | Radiation | Experimental Radiotherapy |
| Radiation Therapystandard of care palliative thoracic radiotherapy using volumetric modulated arc therapy/intensity-modulating radiotherapy | Radiation | Standard Radiotherapy |
Primary outcome
time to definitive quality of life deterioration or death
Time frame: from enrollment until 36 months post radiotherapy
Defined as time from randomization to the first of: i. deterioration in Functional Assessment of Cancer Therapy: Lung Trial Outcome Index score by greater than or equal to 5 points compared to baseline score and with no subsequent improvement to within 5 points of baseline ii. death iii. last follow-up
4 secondary outcomes
Quality of Life - Patient Reported Outcomes
Time frame: From enrollment until 36 months post radiotherapy
Toxicity - Adverse Events that happen to a patient during the clinical trial
Time frame: From enrollment until 36 months post radiotherapy
Freedom from intrathoracic progression
Time frame: From enrollment until 36 months post radiotherapy
Overall Survival
Time frame: From enrollment until 36 months post radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiation Therapy and Radiation Therapy in people with Lung Cancers, run by Chris Goodman at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Goodman, MD (519-685-8650, Chris.Goodman@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to definitive quality of life deterioration or death (time frame: from enrollment until 36 months post radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.