Study Summary
This trial is testing whether a higher dose of radiation to areas of the tumor that are more active will reduce the rate of the cancer coming back in 2 years.
Eligible Conditions
- Non-Small Cell Lung Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: 2 years
2 weeks
Dose Escalation Feasibility
2 years
Dose-Response Characterization
Grade 3-5 Toxicity Rate
Imaging Use
Overall Survival
Progression-Free Survival
Quality of Life EQ-5D
Quality of Life FACT-L
Reduction of local-regional failure rate
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Chemoradiotherapy
1 of 2
Chemoradiotherapy with Integrated Boost Dose
1 of 2
Active Control
Experimental Treatment
78 Total Participants · 2 Treatment Groups
Primary Treatment: Chemoradiotherapy with Integrated Boost Dose · No Placebo Group · N/A
Chemoradiotherapy with Integrated Boost Dose
Radiation
Experimental Group · 1 Intervention: Chemoradiotherapy with Integrated Boost Dose · Intervention Types: RadiationChemoradiotherapy
Radiation
ActiveComparator Group · 1 Intervention: Chemoradiotherapy · Intervention Types: RadiationTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
614 Previous Clinical Trials
402,093 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:are candidates for whole brain radiation therapy (WBRT)
Patients with a tumor or node measuring at least 10mm on a CT scan are candidates for whole brain radiation therapy.
will be allowed to enroll
People who are in good health and have a score of 0-2 on the Eastern Cooperative Oncology Group scale within 4 weeks of being randomized will be allowed to enroll in the study.
at our center
Patients who will undergo radiation therapy as their primary mode of treatment at our center.
were found to have improved OS
Patients with a PET avid tumor having Standardized Uptake Values (SUV) greater than 4 were found to have improved OS.
References
- Raman, Srinivas, Jean-Pierre Bissonnette, Andrew Warner, Lisa Le, Scott Bratman, Natasha Leighl, Andrea Bezjak, David Palma, Devin Schellenberg, and Alexander Sun. 2018. “Rationale and Protocol for a Canadian Multicenter Phase II Randomized Trial Assessing Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non–small-cell Lung Cancer (NCT02788461)”. Clinical Lung Cancer. Elsevier BV. doi:10.1016/j.cllc.2018.05.002.
- David Palma 2016. "Assessing the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02788461.
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Conditions
Cancer Related
Treatments