Non-Small Cell Lung Cancer
Conditions
Keywords
Esophageal sparing, Conventional radiotherapy, Palliative radiation, Central lung tumors
Brief summary
A randomized phase II study of palliative radiation of advanced central lung tumors with intentional avoidance of the esophagus. Patients will be randomized between standard of care palliative thoracic radiation and esophageal-sparing intensity-modulated radiation therapy (ES-IMRT) in a 1:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 1 year after completion of their radiation therapy. The primary endpoint is esophageal quality of life as measured by the Esophageal Cancer Subscore (ECS) of the Functional Assessment of Cancer Therapy-Esophagus (FACT-E).
Interventions
RADIATIONConventional radiotherapy
Patients will receive standard palliative radiation in dose of 30Gy in 10 fractions, or 20Gy in 5 fractions.
RADIATIONEsophageal-Sparing Intensity-Modulated Radiotherapy
Patients will receive esophageal-sparing intensity-modulated radiotherapy, of 30Gy in 10 fractions or 20Gy in 5 fractions.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Joint Committee on Cancer (AJCC) 7th edition stage IV NSCLC or stage III not eligible for curative intent treatment * Intended to receive palliative radiotherapy to the thorax, to a dose of 30Gy in 10 fractions or 20Gy in 5 fractions. In either treatment arm at least 5cm of the esophagus should be in the intended treatment field. * Willingness and ability to provide informed consent * Eastern Cooperative Oncology Group (ECOG) performance status 0-3 * Age 18 years or older * Prior or planned systemic therapy (chemotherapy, immunotherapy, targeted agents) is permissible at the discretion of the treating medical oncologist, provided that no systemic treatment is given within 2 weeks prior to RT, concurrent with RT or within a 2-week period post RT. * Concurrent palliative RT to other metastatic sites is permissible * Life expectancy \> 3 months
Exclusion criteria
* Prior thoracic RT * Serious medical comorbidities precluding RT * Pregnant or lactating women * Inability to attend the full course of RT or planned follow-up visits * Planned concurrent palliative RT to the stomach and/or liver * Congenital abnormalities of the esophagus or severe disorders of the esophagus (e.g. achalasia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal Quality of Life | 2 weeks after completion of radiotherapy | Esophageal quality of life will be measured by the ECS of the FACT-E, measured at 2 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity Rate Differences | 6 months after completion of radiotherapy | Differences in rates of grade 2 or higher toxicity between groups will be tested using the Fisher's Exact test. |
| Progression-Free Survival | 6 months after completion of radiotherapy | Differences in local/regional progression-free survival will be tested using the stratified log-rank test |
| Further Systemic Therapy | 6 months after completion of radiotherapy | Differences in number of cycles of further systemic therapy will be tested using the student's t-test |
| Cost-Effectiveness/Utility Analysis | 6 months after completion of radiotherapy | European Quality of Life-5 Dimensions (EQ-5D) measurements will be converted into utilities to inform cost-effectiveness/utility analysis. |
| Survival | 6 months after completion of radiotherapy | Survival |
| Dosimetry Comparison - Planning Target Volume (PTV) | 6 months after completion of radiotherapy | Dosimetric comparison of PTV will be compared using the student's t-test. |
| Dosimetry Comparison - Pulmonary Metrics | 6 months after completion of radiotherapy | Dosimetric comparison of standard pulmonary metrics will be compared using the student's t-test. |
| Dosimetry Comparison - Esophageal Metrics | 6 months after completion of radiotherapy | Dosimetric comparison of standard esophageal metrics will be compared using the student's t-test. |
| Dosimetry Comparison - Gross Tumor Volume (GTV) | 6 months after completion of radiotherapy | Dosimetric comparison of GTV will be compared using the student's t-test. |
Countries
Canada
Outcome results
None listed