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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Radiotherapy | Active Comparator | 20 Gray in 5 fractions or 30 Gray in 10 fractions. |
|
| Experimental Radiotherapy | Experimental | 35 Gray in 5 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | Hypofractionated, dose-escalated, esophageal-sparing intensity modulated radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to definitive quality of life deterioration or death | 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 | from enrollment until 36 months post radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life - Patient Reported Outcomes | Measured via Functional Assessment of Cancer Therapy: Lung and EuroQol 5-dimension 5-level | From enrollment until 36 months post radiotherapy |
| Toxicity - Adverse Events that happen to a patient during the clinical trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Goodman, MD | Contact | 519-685-8650 | Chris.Goodman@lhsc.on.ca | |
| David Palma, MD | Contact | 519-685-8650 | David.Palma@lhsc.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British Columbia Cancer Agency Center for the Southern Interior | Recruiting | Kelowna | British Columbia | V1Y5L3 | Canada |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Radiation Therapy | Radiation | standard of care palliative thoracic radiotherapy using volumetric modulated arc therapy/intensity-modulating radiotherapy |
|
Defined as incidence of Common Terminology Criteria for Adverse Events version 5 grade 2 and higher toxicity |
| From enrollment until 36 months post radiotherapy |
| Freedom from intrathoracic progression | Defined as time from randomization to disease progression within the thorax, or last follow-up, whichever occurs first | From enrollment until 36 months post radiotherapy |
| Overall Survival | Defined as time from randomization to death from any cause, or last follow-up, whichever occurs first | From enrollment until 36 months post radiotherapy |
| London Health Sciences Center Research Institute (Formerly Lawson Research Institute) | Recruiting | London | Ontario | N6A 4L6 | Canada |
|
| Waterloo Regional Health Network | Recruiting | Waterloo | Ontario | Canada |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |