Chemoradiotherapy
RadiationPatients will receive radiotherapy of 60Gy in 30 fractions (5x per week) with concurrent cisplatin and etoposide chemotherapy.
NCT Number: NCT02788461
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Kingston General Hospital, Kingston, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2 years
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
Determine if dose escalation to metabolically active subvolumes will improve progression-free survival at 2 years
Time frame: 2 years
Determine if dose escalation to metabolically active subvolumes will improve overall survival at 2 years
Time frame: 2 years
Determine if dose escalation to metabolically active subvolumes will increase the rate of grade 3-5 toxicities
Time frame: 2 years
Compare the quality of life in the two arms using Functional Assessment of Cancer Therapy-Lung (FACT-L) instrument
Time frame: 2 years
Compare the quality of life in the two arms using EuroQol Quality of Life-5 Dimensions (EQ-5D) instrument
Time frame: 2 years
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 weeks
Explore the feasibility of adaptive dose escalation based on PET response at week 2
Time frame: 2 years
Explore the use of Week 0 and Week 2 PET images for prognostication and response assessment for local-regional failure at 2 years
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Other
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
Acronym: PET-BOOST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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