Higher-dose, short-course chest radiation that spares the esophagus
A Phase II/III Randomized Evaluation of Dose-escalation With Esophageal-sparing for Palliation of Intrathoracic Tumours (PREVENT)
NA · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · NCT06794125
This trial will try a five-session, higher-dose, esophagus-sparing radiation schedule for adults with intrathoracic tumors who need palliative chest radiation, compared with standard palliative radiation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 141 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 3 sites (Kelowna, British Columbia and 2 other locations) |
| Trial ID | NCT06794125 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with intrathoracic tumors needing palliative thoracic radiation, ECOG performance status 0–3, life expectancy over 3 months, and no prior thoracic radiation that prevents further safe treatment are ideal candidates.
Not a fit: Patients with prior thoracic radiation that precludes additional treatment, life expectancy under three months, or inability to attend a participating center are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could prolong symptom control and high-quality survival while reducing esophageal side effects compared with conventional palliative radiation.
How similar studies have performed: Advanced IMRT planning and hypofractionation have been used successfully in other thoracic settings, but randomized data for this specific dose-escalated, esophagus-sparing palliative approach are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kelowna, British Columbia and 2 other locations
- British Columbia Cancer Agency Center for the Southern Interior — Kelowna, British Columbia, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Cancers, lung cancer, radiation therapy, hypofractionated, esophageal-sparing, dose-escalated, intrathoracic