A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus (PROACTIVE)
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|ClinicalTrials.gov Identifier: NCT02752126|
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : February 25, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Radiation: Conventional radiotherapy Radiation: Esophageal-Sparing Intensity-Modulated Radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||August 1, 2020|
|Actual Study Completion Date :||September 1, 2020|
Active Comparator: Standard Palliative Radiation
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.
Radiation: Conventional radiotherapy
Patients will receive standard palliative radiation in dose of 30Gy in 10 fractions, or 20Gy in 5 fractions.
Experimental: Esophageal Sparing IMRT
Patients on the experimental arm will receive esophageal-sparing intensity-modulated radiotherapy, with the same dose(s) as in the standard arm.
Radiation: Esophageal-Sparing Intensity-Modulated Radiotherapy
Patients will receive esophageal-sparing intensity-modulated radiotherapy, of 30Gy in 10 fractions or 20Gy in 5 fractions.
- Esophageal Quality of Life [ Time Frame: 2 weeks after completion of radiotherapy ]Esophageal quality of life will be measured by the ECS of the FACT-E, measured at 2 weeks.
- Survival [ Time Frame: 6 months after completion of radiotherapy ]Survival
- Toxicity Rate Differences [ Time Frame: 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.
- Progression-Free Survival [ Time Frame: 6 months after completion of radiotherapy ]Differences in local/regional progression-free survival will be tested using the stratified log-rank test
- Further Systemic Therapy [ Time Frame: 6 months after completion of radiotherapy ]Differences in number of cycles of further systemic therapy will be tested using the student's t-test
- Cost-Effectiveness/Utility Analysis [ Time Frame: 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 - Gross Tumor Volume (GTV) [ Time Frame: 6 months after completion of radiotherapy ]Dosimetric comparison of GTV will be compared using the student's t-test.
- Dosimetry Comparison - Planning Target Volume (PTV) [ Time Frame: 6 months after completion of radiotherapy ]Dosimetric comparison of PTV will be compared using the student's t-test.
- Dosimetry Comparison - Pulmonary Metrics [ Time Frame: 6 months after completion of radiotherapy ]Dosimetric comparison of standard pulmonary metrics will be compared using the student's t-test.
- Dosimetry Comparison - Esophageal Metrics [ Time Frame: 6 months after completion of radiotherapy ]Dosimetric comparison of standard esophageal metrics will be compared using the student's t-test.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752126
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, Nova Scotia|
|Atlantic Clinical Cancer Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Grand River Regional Cancer Centre/Grand River Hospital|
|Kitchener, Ontario, Canada, N2G 1G3|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Princess Margaret Hospital/ University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|Trillium Health Partners - Credit Valley Hospital|
|Mississauga, ONT, Canada, L5M 2N1|
|McGill University Health Centre|
|Montréal, Quebec, Canada, H3H 2R9|
|Responsible Party:||Alexander Louie, Radiation Oncologist, Lawson Health Research Institute|
|Other Study ID Numbers:||
|First Posted:||April 26, 2016 Key Record Dates|
|Last Update Posted:||February 25, 2021|
|Last Verified:||February 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Central lung tumors
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases