An Evaluation of Dose-escalation for Intrathoracic Tumours

NCT ID: NCT06794125

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-03

Study Completion Date

2029-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Radiotherapy

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

Group Type ACTIVE_COMPARATOR

Radiation Therapy

Intervention Type RADIATION

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

Experimental Radiotherapy

35 Gray in 5 fractions

Group Type EXPERIMENTAL

Hypofractionated Radiation Therapy

Intervention Type RADIATION

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

Interventions

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Hypofractionated Radiation Therapy

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

Intervention Type RADIATION

Radiation Therapy

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chris Goodman

OTHER

Sponsor Role lead

Responsible Party

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Chris Goodman

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

London, Ontario, Canada

Site Status RECRUITING

Waterloo Regional Health Network

Waterloo, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Christopher Goodman, MD

Role: CONTACT

519-685-8650

David Palma, MD

Role: CONTACT

519-685-8650

Facility Contacts

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Chris Goodman, MD

Role: primary

519-685-8500 ext. 53286

David Palma, MD

Role: backup

519-685-8500 ext. 56859

Stephanie Nemirov

Role: primary

519-749-4300 ext. 2447

Sameen Saad

Role: backup

519-749-4300 ext. 2447

Other Identifiers

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PREVENT-LUNG

Identifier Type: -

Identifier Source: org_study_id

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