Back to resultsA Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus (PROACTIVE)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Conventional radiotherapy
Esophageal-Sparing Intensity-Modulated Radiotherapy
Sponsored by
About this trial
This is an interventional supportive care trial for Non-Small Cell Lung Cancer focused on measuring Esophageal sparing, Conventional radiotherapy, Palliative radiation, Central lung tumors
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)
Sites / Locations
- Cross Cancer Institute
- Atlantic Clinical Cancer Centre
- Grand River Regional Cancer Centre/Grand River Hospital
- London Regional Cancer Program
- Princess Margaret Hospital/ University Health Network
- Trillium Health Partners - Credit Valley Hospital
- McGill University Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Palliative Radiation
Esophageal Sparing IMRT
Arm Description
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.
Patients on the experimental arm will receive esophageal-sparing intensity-modulated radiotherapy, with the same dose(s) as in the standard arm.
Outcomes
Primary Outcome Measures
Esophageal Quality of Life
Esophageal quality of life will be measured by the ECS of the FACT-E, measured at 2 weeks.
Secondary Outcome Measures
Survival
Survival
Toxicity Rate Differences
Differences in rates of grade 2 or higher toxicity between groups will be tested using the Fisher's Exact test.
Progression-Free Survival
Differences in local/regional progression-free survival will be tested using the stratified log-rank test
Further Systemic Therapy
Differences in number of cycles of further systemic therapy will be tested using the student's t-test
Cost-Effectiveness/Utility Analysis
European Quality of Life-5 Dimensions (EQ-5D) measurements will be converted into utilities to inform cost-effectiveness/utility analysis.
Dosimetry Comparison - Gross Tumor Volume (GTV)
Dosimetric comparison of GTV will be compared using the student's t-test.
Dosimetry Comparison - Planning Target Volume (PTV)
Dosimetric comparison of PTV will be compared using the student's t-test.
Dosimetry Comparison - Pulmonary Metrics
Dosimetric comparison of standard pulmonary metrics will be compared using the student's t-test.
Dosimetry Comparison - Esophageal Metrics
Dosimetric comparison of standard esophageal metrics will be compared using the student's t-test.
Full Information
NCT ID
NCT02752126
First Posted
April 22, 2016
Last Updated
February 24, 2021
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02752126
Brief Title
A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus
Acronym
PROACTIVE
Official Title
A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Esophageal sparing, Conventional radiotherapy, Palliative radiation, Central lung tumors
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Palliative Radiation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Esophageal Sparing IMRT
Arm Type
Experimental
Arm Description
Patients on the experimental arm will receive esophageal-sparing intensity-modulated radiotherapy, with the same dose(s) as in the standard arm.
Intervention Type
Radiation
Intervention Name(s)
Conventional radiotherapy
Intervention Description
Patients will receive standard palliative radiation in dose of 30Gy in 10 fractions, or 20Gy in 5 fractions.
Intervention Type
Radiation
Intervention Name(s)
Esophageal-Sparing Intensity-Modulated Radiotherapy
Intervention Description
Patients will receive esophageal-sparing intensity-modulated radiotherapy, of 30Gy in 10 fractions or 20Gy in 5 fractions.
Primary Outcome Measure Information:
Title
Esophageal Quality of Life
Description
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
Secondary Outcome Measure Information:
Title
Survival
Description
Survival
Time Frame
6 months after completion of radiotherapy
Title
Toxicity Rate Differences
Description
Differences in rates of grade 2 or higher toxicity between groups will be tested using the Fisher's Exact test.
Time Frame
6 months after completion of radiotherapy
Title
Progression-Free Survival
Description
Differences in local/regional progression-free survival will be tested using the stratified log-rank test
Time Frame
6 months after completion of radiotherapy
Title
Further Systemic Therapy
Description
Differences in number of cycles of further systemic therapy will be tested using the student's t-test
Time Frame
6 months after completion of radiotherapy
Title
Cost-Effectiveness/Utility Analysis
Description
European Quality of Life-5 Dimensions (EQ-5D) measurements will be converted into utilities to inform cost-effectiveness/utility analysis.
Time Frame
6 months after completion of radiotherapy
Title
Dosimetry Comparison - Gross Tumor Volume (GTV)
Description
Dosimetric comparison of GTV will be compared using the student's t-test.
Time Frame
6 months after completion of radiotherapy
Title
Dosimetry Comparison - Planning Target Volume (PTV)
Description
Dosimetric comparison of PTV will be compared using the student's t-test.
Time Frame
6 months after completion of radiotherapy
Title
Dosimetry Comparison - Pulmonary Metrics
Description
Dosimetric comparison of standard pulmonary metrics will be compared using the student's t-test.
Time Frame
6 months after completion of radiotherapy
Title
Dosimetry Comparison - Esophageal Metrics
Description
Dosimetric comparison of standard esophageal metrics will be compared using the student's t-test.
Time Frame
6 months after completion of radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Atlantic Clinical Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Grand River Regional Cancer Centre/Grand River Hospital
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Hospital/ University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Trillium Health Partners - Credit Valley Hospital
City
Mississauga
State/Province
ONT
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3H 2R9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35201290
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.
Results Reference
derived
Learn more about this trial
A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus
We'll reach out to this number within 24 hrs