An Evaluation of Dose-escalation for Intrathoracic Tumours (PREVENT-LUNG)

September 10, 2026 updated by: Chris Goodman

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y5L3
        • Recruiting
        • British Columbia Cancer Agency Center for the Southern Interior
        • Sub-Investigator:
          • David Petrik, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Kennedy, MD
        • Sub-Investigator:
          • Angela Lin, MD
        • Sub-Investigator:
          • Benjamin Mou, MD
        • Sub-Investigator:
          • Siavash Atrchian, MD
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Recruiting
        • Horizon Health New Brunswick
        • Principal Investigator:
          • Robert Thompson, MD
        • Sub-Investigator:
          • Farah Naz, MD
        • Sub-Investigator:
          • Arpita Sengupta, MD
        • Sub-Investigator:
          • Marissa Sherwood, MD
        • Contact:
        • Sub-Investigator:
          • Holly Campbell, MD
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Recruiting
        • London Health Sciences Center Research Institute (Formerly Lawson Research Institute)
        • Sub-Investigator:
          • David Palma, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chris Goodman, MD
        • Sub-Investigator:
          • Joanna Laba, MD
        • Sub-Investigator:
          • Pencilla Lang, MD
        • Sub-Investigator:
          • George Rodrigues, MD
        • Sub-Investigator:
          • Melody Qu, MD
        • Sub-Investigator:
          • Brian Yaremko, MD
      • Waterloo, Ontario, Canada
        • Recruiting
        • Waterloo Regional Health Network
        • Principal Investigator:
          • Darin Gopaul, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Daniel Glick, MD
        • Sub-Investigator:
          • Joda Kuk, MD
        • Sub-Investigator:
          • Mario Valdes, MD
        • Sub-Investigator:
          • Nadia Califaretti, MD
        • Sub-Investigator:
          • Stacey Hubay, MD
        • Sub-Investigator:
          • Shelley Kuang, MD
        • Sub-Investigator:
          • Sundeep Shahi, MD
        • Sub-Investigator:
          • Andrea Molchovsky, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Radiotherapy
20 Gray in 5 fractions or 30 Gray in 10 fractions.
Radiation: Radiation Therapy
standard of care palliative thoracic radiotherapy using volumetric modulated arc therapy/intensity-modulating radiotherapy
Experimental: Experimental Radiotherapy
35 Gray in 5 fractions
Radiation: Hypofractionated Radiation Therapy
Hypofractionated, dose-escalated, esophageal-sparing intensity modulated radiation therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
from enrollment until 36 months post radiotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Freedom from intrathoracic progression
Time Frame: From enrollment until 36 months post radiotherapy
Defined as time from randomization to disease progression within the thorax, or last follow-up, whichever occurs first
From enrollment until 36 months post radiotherapy
Overall Survival
Time Frame: From enrollment until 36 months post radiotherapy
Defined as time from randomization to death from any cause, or last follow-up, whichever occurs first
From enrollment until 36 months post radiotherapy
Quality of Life - Patient Reported Outcomes
Time Frame: From enrollment until 36 months post radiotherapy
Measured via Functional Assessment of Cancer Therapy: Lung and EuroQol 5-dimension 5-level
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
Defined as incidence of Common Terminology Criteria for Adverse Events version 5 grade 2 and higher toxicity
From enrollment until 36 months post radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chris Goodman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PREVENT-LUNG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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