Recruiting

RT vs. HD-ES IMRT

Sponsor:

Chris Goodman

Code:

NCT06794125

Conditions

Lung Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypofractionated Radiation Therapy

Radiation Therapy

Study Details

Brief 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).

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

Study ID

NCT06794125

Start date

Sep 3, 2025

Status verified date

Jan, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

141 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Radiotherapy

20 Gray in 5 fractions or 30 Gray in 10 fractions.

experimental: Experimental Radiotherapy

35 Gray in 5 fractions

Interventions

Hypofractionated Radiation Therapy

Hypofractionated, dose-escalated, esophageal-sparing intensity modulated radiation therapy

Radiation Therapy

standard of care palliative thoracic radiotherapy using volumetric modulated arc therapy/intensity-modulating radiotherapy

Primary outcome measure

  • time to definitive quality of life deterioration or death [ Time Frame: from enrollment until 36 months post radiotherapy ]

Central Contacts and Locations

Central contacts

Christopher Goodman, MD

519-685-8650Chris.Goodman@lhsc.on.ca

David Palma, MD

519-685-8650David.Palma@lhsc.on.ca

Locations

British Columbia Cancer Agency Center for the Southern Interior

Recruiting

Kelowna, British Columbia, Canada, V1Y5L3

Contacts

Thomas Kennedy, MD

250-717-4272thomas.kennedy@bccancer.bc.ca

Jenny Petterson

250-717-4272jennifer.petterson@bccancer.bc.ca

Principal Investigator:

Thomas Kennedy, MD

London Health Sciences Center Research Institute (Formerly Lawson Research Institute)

Recruiting

London, Ontario, Canada, N6A 4L6

Contacts

Chris Goodman, MD

519-685-8500chris.Goodman@lhsc.on.ca

David Palma, MD

519-685-8500david.palma@lhsc.on.ca

Principal Investigator:

Chris Goodman, MD

Waterloo Regional Health Network

Recruiting

Waterloo, Ontario, Canada

Contacts

Stephanie Nemirov

519-749-4300stephanie.nemirov@wrhn.ca

Sameen Saad

519-749-4300sameen.saad@wrhn.ca

Principal Investigator:

Darin Gopaul, MD

More Information

Sponsor

Chris Goodman

Last update posted

Feb 4, 2026

Last verified

Jan, 2026

Keywords

  • lung cancer
  • radiation therapy
  • hypofractionated
  • esophageal-sparing
  • dose-escalated
  • intrathoracic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Chris Goodman on 2026-02-04.