Clinical trial NCT06794125: An Evaluation of Dose-escalation for Intrathoracic Tumours
Official title: A Phase II/III Randomized Evaluation of Dose-escalation With Esophageal-sparing for Palliation of Intrathoracic Tumours (PREVENT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancers
Keywords: lung cancer
radiation therapy
hypofractionated
esophageal-sparing
dose-escalated
intrathoracic
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: time to definitive quality of life deterioration or death
timeFrame: from enrollment until 36 months post radiotherapy
Secondary outcomes:
measure: Quality of Life - Patient Reported Outcomes
timeFrame: From enrollment until 36 months post radiotherapy
measure: Toxicity - Adverse Events that happen to a patient during the clinical trial
timeFrame: From enrollment until 36 months post radiotherapy
measure: Freedom from intrathoracic progression
timeFrame: From enrollment until 36 months post radiotherapy
measure: Overall Survival
timeFrame: From enrollment until 36 months post radiotherapy
Other outcomes:
Locations:
Study officials:
References: