A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus (PROACTIVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02752126|
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : September 28, 2018
|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)|
|Estimated 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|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 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.
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
|Contact: Alexander Louie, MD, PhD, MSc, FRCPC||519-685-8500 ext email@example.com|
|Contact: Al Grattonfirstname.lastname@example.org|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Contact: Juliette Jordan 780-432-8992 Juliette.Jordan@albertahealthservices.ca|
|Sub-Investigator: Alysa Fairchild, FRCP|
|Sub-Investigator: Zsolt Gabos, FRCP|
|Canada, Nova Scotia|
|Atlantic Clinical Cancer Centre||Recruiting|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Contact: Jennifer MacVicar 902-473-7257 Jennifer.MacVicar@nshealth.ca|
|Sub-Investigator: Liam Mulroy, FRCP|
|Grand River Regional Cancer Centre/Grand River Hospital||Recruiting|
|Kitchener, Ontario, Canada, N2G 1G3|
|Contact: Darin Gopaul, FRCP 519-749-4380 email@example.com|
|Contact: Elyse Wellhauser : 519-749-4370 ext 2447 Elyse.Wellhauser@grhosp.on.ca|
|Principal Investigator: Darindra Gopaul, FRCP|
|London Regional Cancer Program||Recruiting|
|London, Ontario, Canada, N6A 4L6|
|Contact: Anne O'Connell 519-685-8618 firstname.lastname@example.org|
|Contact: Al Gratton 519-685-8618 email@example.com|
|Principal Investigator: Alexander Louie, MD, PhD, MSc, FRCPC|
|Princess Margaret Hospital/ University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Andrea Bezjak, Msc, MDCM, FRCPC (416) 946-2132 firstname.lastname@example.org|
|Trillium Health Partners - Credit Valley Hospital||Recruiting|
|Mississauga, ONT, Canada, L5M 2N1|
|Contact: Matthew D'Ascanio (905) 813 1100 ext 5057 Matthew.email@example.com|
|Principal Investigator: Anthony Blade, MD, CM, PhD, FRCPC|
|McGill University Health Centre||Recruiting|
|Montréal, Quebec, Canada, H3H 2R9|
|Contact: Marianna Perna 514-934-1934 ext 43191 firstname.lastname@example.org|
|Principal Investigator: Sergio Faria, PhD|