Clinical trial NCT02752126: A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus
Official title: A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: Esophageal sparing
Conventional radiotherapy
Palliative radiation
Central lung tumors
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Esophageal Quality of Life
timeFrame: 2 weeks after completion of radiotherapy
Secondary outcomes:
measure: Survival
timeFrame: 6 months after completion of radiotherapy
measure: Toxicity Rate Differences
timeFrame: 6 months after completion of radiotherapy
measure: Progression-Free Survival
timeFrame: 6 months after completion of radiotherapy
measure: Further Systemic Therapy
timeFrame: 6 months after completion of radiotherapy
measure: Cost-Effectiveness/Utility Analysis
timeFrame: 6 months after completion of radiotherapy
measure: Dosimetry Comparison - Gross Tumor Volume (GTV)
timeFrame: 6 months after completion of radiotherapy
measure: Dosimetry Comparison - Planning Target Volume (PTV)
timeFrame: 6 months after completion of radiotherapy
measure: Dosimetry Comparison - Pulmonary Metrics
timeFrame: 6 months after completion of radiotherapy
measure: Dosimetry Comparison - Esophageal Metrics
timeFrame: 6 months after completion of radiotherapy
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Halifax
country: Canada
facility: Atlantic Clinical Cancer Centre
state: Nova Scotia
city: Kitchener
country: Canada
facility: Grand River Regional Cancer Centre/Grand River Hospital
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital/ University Health Network
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners - Credit Valley Hospital
state: ONT
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References:
citation: Louie AV, Granton PV, Fairchild A, Bezjak A, Gopaul D, Mulroy L, Brade A, Warner A, Debenham B, Bowes D, Kuk J, Sun A, Hoover D, Rodrigues GB, Palma DA. Palliative Radiation for Advanced Central Lung Tumors With Intentional Avoidance of the Esophagus (PROACTIVE): A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):1-7. doi: 10.1001/jamaoncol.2021.7664.