Lung Cancers
Conditions
Keywords
lung cancer, radiation therapy, hypofractionated, esophageal-sparing, dose-escalated, intrathoracic
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.
Interventions
RADIATIONHypofractionated Radiation Therapy
Hypofractionated, dose-escalated, esophageal-sparing intensity modulated radiation therapy
RADIATIONRadiation Therapy
standard of care palliative thoracic radiotherapy using volumetric modulated arc therapy/intensity-modulating radiotherapy
Sponsors
Chris Goodman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to definitive quality of life deterioration or death | from enrollment until 36 months post radiotherapy | Defined as time from randomization to the first of: i. deterioration in Functional Assessment of Cancer Therapy: Lung Trial Outcome Index score by greater than or equal to 5 points compared to baseline score and with no subsequent improvement to within 5 points of baseline ii. death iii. last follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - Patient Reported Outcomes | From enrollment until 36 months post radiotherapy | Measured via Functional Assessment of Cancer Therapy: Lung and EuroQol 5-dimension 5-level |
| Toxicity - Adverse Events that happen to a patient during the clinical trial | From enrollment until 36 months post radiotherapy | Defined as incidence of Common Terminology Criteria for Adverse Events version 5 grade 2 and higher toxicity |
| Freedom from intrathoracic progression | From enrollment until 36 months post radiotherapy | Defined as time from randomization to disease progression within the thorax, or last follow-up, whichever occurs first |
| Overall Survival | From enrollment until 36 months post radiotherapy | Defined as time from randomization to death from any cause, or last follow-up, whichever occurs first |
Countries
Canada
Contacts
CONTACTChristopher Goodman, MD
CONTACTDavid Palma, MD
Outcome results
None listed