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

Non-Small Cell Lung Cancer Clinical Trial

— PROACTIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752126
• Other study ID #: PROACTIVE
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: September 1, 2020

Study information

• Verified date: February 2021
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Radiation:
• Conventional radiotherapy
Patients will receive standard palliative radiation in dose of 30Gy in 10 fractions, or 20Gy in 5 fractions.
• Esophageal-Sparing Intensity-Modulated Radiotherapy
Patients will receive esophageal-sparing intensity-modulated radiotherapy, of 30Gy in 10 fractions or 20Gy in 5 fractions.

Locations

Country	Name	City	State
Canada	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	ONT
Canada	McGill University Health Centre	Montréal	Quebec
Canada	Princess Margaret Hospital/ University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal Quality of Life	Esophageal quality of life will be measured by the ECS of the FACT-E, measured at 2 weeks.	2 weeks after completion of radiotherapy
Secondary	Survival	Survival	6 months after completion of radiotherapy
Secondary	Toxicity Rate Differences	Differences in rates of grade 2 or higher toxicity between groups will be tested using the Fisher's Exact test.	6 months after completion of radiotherapy
Secondary	Progression-Free Survival	Differences in local/regional progression-free survival will be tested using the stratified log-rank test	6 months after completion of radiotherapy
Secondary	Further Systemic Therapy	Differences in number of cycles of further systemic therapy will be tested using the student's t-test	6 months after completion of radiotherapy
Secondary	Cost-Effectiveness/Utility Analysis	European Quality of Life-5 Dimensions (EQ-5D) measurements will be converted into utilities to inform cost-effectiveness/utility analysis.	6 months after completion of radiotherapy
Secondary	Dosimetry Comparison - Gross Tumor Volume (GTV)	Dosimetric comparison of GTV will be compared using the student's t-test.	6 months after completion of radiotherapy
Secondary	Dosimetry Comparison - Planning Target Volume (PTV)	Dosimetric comparison of PTV will be compared using the student's t-test.	6 months after completion of radiotherapy
Secondary	Dosimetry Comparison - Pulmonary Metrics	Dosimetric comparison of standard pulmonary metrics will be compared using the student's t-test.	6 months after completion of radiotherapy
Secondary	Dosimetry Comparison - Esophageal Metrics	Dosimetric comparison of standard esophageal metrics will be compared using the student's t-test.	6 months after completion of radiotherapy