Higher-dose, short-course chest radiation that spares the esophagus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized pragmatic trial compares standard palliative thoracic radiation with a hypofractionated, dose-escalated, esophageal-sparing (HD-ES) IMRT regimen delivered in five fractions. The approach uses advanced IMRT planning to limit dose to the esophagus while modestly escalating the biologically effective dose to intrathoracic tumors. Eligible adults with lung cancer or other intrathoracic malignancies who require palliative chest radiotherapy and have ECOG 0–3 are randomized and treated at participating Canadian centers. The trial aims to see if the HD-ES schedule improves high-quality survival and toxicity outcomes versus conventional palliative schedules.

Why it matters

Who can join: the full rules

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

Where it's running

• British Columbia Cancer Agency Center for the Southern Interior
  Kelowna, British Columbia, Canada Recruiting
• Horizon Health New Brunswick
  Saint John, New Brunswick, Canada Recruiting
• London Health Sciences Center Research Institute (Formerly Lawson Research Institute)
  London, Ontario, Canada Recruiting
• Waterloo Regional Health Network
  Waterloo, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Christopher Goodman, MD
• Email: Chris.Goodman@lhsc.on.ca
• Phone: 519-685-8650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.