A randomized phase II trial to assess the efficacy and safety of selective metabolically adaptive radiation dose escalation in locally advanced non-small cell lung cancer receiving definitive chemoradiotherapy. Eligible and consenting patients will be randomized to receive conventional chemoradiotherapy or chemoradiotherapy with a radiation (RT) integrated boost. All patients will receive a fludeoxyglucose-positron emission tomography (FDG-PET) scan within two weeks prior to starting treatment. The primary outcome is to determine if dose escalation to metabolically active tumor subvolumes will reduce local-regional failure rate at 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Patients will receive radiotherapy of 60Gy in 30 fractions (5x per week) with concurrent cisplatin and etoposide chemotherapy.
Patients will receive an RT integrated boost to tumor subvolumes (max boost dose of 85Gy) in 30 fractions (5x per week) with concurrent cisplatin and etoposide chemotherapy.
Kingston General Hospital
Kingston, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Stronach Regional Cancer Centre at Southlake Regional Health Centre
Newmarket, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre, Glen site Cedars Cancer Center
Montreal, Quebec, Canada
CHU de Quebec - L'Hôtel-Dieu de Québec
Québec, Quebec, Canada
CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, Canada
Reduction of local-regional failure rate
Primary outcome of the trial is to determine if dose escalation to metabolically active subvolumes will reduce local-regional failure rate
Time frame: 2 years
Progression-Free Survival
Determine if dose escalation to metabolically active subvolumes will improve progression-free survival at 2 years
Time frame: 2 years
Overall Survival
Determine if dose escalation to metabolically active subvolumes will improve overall survival at 2 years
Time frame: 2 years
Grade 3-5 Toxicity Rate
Determine if dose escalation to metabolically active subvolumes will increase the rate of grade 3-5 toxicities
Time frame: 2 years
Quality of Life FACT-L
Compare the quality of life in the two arms using Functional Assessment of Cancer Therapy-Lung (FACT-L) instrument
Time frame: 2 years
Quality of Life EQ-5D
Compare the quality of life in the two arms using EuroQol Quality of Life-5 Dimensions (EQ-5D) instrument
Time frame: 2 years
Dose-Response Characterization
Characterize the tumor dose-response relationship in the experimental arm and create a tumor control probability model for local-regional failure at 2 years
Time frame: 2 years
Dose Escalation Feasibility
Explore the feasibility of adaptive dose escalation based on PET response at week 2
Time frame: 2 weeks
Imaging Use
Explore the use of Week 0 and Week 2 PET images for prognostication and response assessment for local-regional failure at 2 years
Time frame: 2 years
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