NCT02752126CompletedNot Applicable
A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus
Lawson Health Research Institute14 sites in 1 country90 target enrollmentStarted: June 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 14
- Primary Endpoint
- Esophageal Quality of Life
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
Esophageal Quality of Life
Time Frame: 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 Outcomes
- Further Systemic Therapy(6 months after completion of radiotherapy)
- Dosimetry Comparison - Gross Tumor Volume (GTV)(6 months after completion of radiotherapy)
- Survival(6 months after completion of radiotherapy)
- Dosimetry Comparison - Pulmonary Metrics(6 months after completion of radiotherapy)
- Toxicity Rate Differences(6 months after completion of radiotherapy)
- Dosimetry Comparison - Esophageal Metrics(6 months after completion of radiotherapy)
- Progression-Free Survival(6 months after completion of radiotherapy)
- Cost-Effectiveness/Utility Analysis(6 months after completion of radiotherapy)
- Dosimetry Comparison - Planning Target Volume (PTV)(6 months after completion of radiotherapy)
Investigators
Alexander Louie
Radiation Oncologist
Lawson Health Research Institute
Study Sites (14)
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