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

Not Applicable

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Radiation: Conventional radiotherapy; Radiation: Esophageal-Sparing Intensity-Modulated Radiotherapy

• Registration Number: NCT02752126
• Lead Sponsor: Lawson Health Research Institute

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-26
• Study Start: 2016-06
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Palliative Radiation	Conventional radiotherapy	Patients in the standard arm will receive a conventional radiotherapy dose will be either 30 gray (Gy) in 10 fraction or 20Gy in 5 fractions. Patients will be stratified by intended dose prior to randomization. Radiation for patients in the standard arm should adhere to the principles of palliative radiation, with goals of alleviating symptoms or preventing potential complications.
Esophageal Sparing IMRT	Esophageal-Sparing Intensity-Modulated Radiotherapy	Patients on the experimental arm will receive esophageal-sparing intensity-modulated radiotherapy, with the same dose(s) as in the standard arm.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
Survival	6 months after completion of radiotherapy	Survival
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.
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.
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.
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
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.
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.

Trial Locations

Locations (7)

Trillium Health Partners - Credit Valley Hospital; 🇨🇦 Mississauga, ONT, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

Grand River Regional Cancer Centre/Grand River Hospital; 🇨🇦 Kitchener, Ontario, Canada

Atlantic Clinical Cancer Centre; 🇨🇦 Halifax, Nova Scotia, Canada

London Regional Cancer Program; 🇨🇦 London, Ontario, Canada

Princess Margaret Hospital/ University Health Network; 🇨🇦 Toronto, Ontario, Canada

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada