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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

141

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

September 3, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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