A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumours With Intentional Avoidance of the Esophagus

Official Title

A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumours With Intentional Avoidance of the Esophagus

Summary:

A randomized phase II study of palliative radiation of advanced central lung tumours 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. Radiation Therapy 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).

Trial Description

Primary Outcome:

  • Esophageal Quality of Life
Secondary Outcome:
  • Survival
  • Toxicity Rate Differences
  • Progression-Free Survival
  • Further Systemic Therapy
  • Cost-Effectiveness/Utility Analysis
  • Dosimetry Comparison - Gross Tumour Volume (GTV)
  • Dosimetry Comparison - Planning Target Volume (PTV)
  • Dosimetry Comparison - Pulmonary Metrics
  • Dosimetry Comparison - Esophageal Metrics

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society