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

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (7)

Cross Cancer Institute

Edmonton, Alberta, Canada

Atlantic Clinical Cancer Centre

Halifax, Nova Scotia, Canada

Grand River Regional Cancer Centre/Grand River Hospital

Kitchener, Ontario, Canada

London Regional Cancer Program

London, Ontario, Canada

Trillium Health Partners - Credit Valley Hospital

Mississauga, Ontario, Canada

Princess Margaret Hospital/ University Health Network

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Esophageal Quality of Life

Esophageal quality of life will be measured by the ECS of the FACT-E, measured at 2 weeks.

Time frame: 2 weeks after completion of radiotherapy