Active, not recruitingNCT02788461PET-BOOSTUpdated Sep 18, 2025

Assessing the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy

An interventional study of Chemoradiotherapy and Chemoradiotherapy with Integrated Boost Dose in Non-Small Cell Lung Cancer, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Active, not recruiting at 7 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as active, not recruiting.

Phase: Not applicable
Study type: Interventional
Enrollment: 78
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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.

Conditions studied

Non-Small Cell Lung Cancer

Browse trials for

Carcinoma, Non-Small-Cell Lung 6,488

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 78 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients who are at least 18 years old and are able to consent
Patients who will undergo Chemo-RT as primarily modality of treatment
Patients with a primary tumor or node measuring at least 10mm on CT scan
Patients with a PET avid tumor having Standardized Uptake Values (SUV) > 4
Patients with Eastern Cooperative Oncology Group (ECOG) status 0-2 within 4 weeks of randomization

Exclusion criteria

Exclusion Criteria:

Trimodality patients who have surgery as part of curative treatment
Previous radiotherapy to intended treatment volumes
Active invasive malignancy other than lung cancer
Active pregnancy
Poor respiratory function (Forced Expiratory Volume \< 1.0 or Diffusing Capacity \< 50% age-adjusted normal)
ECOG status > 2
Pre-treatment complete blood count/differential showing inadequate bone marrow reserve (absolute neutrophil count \< 1800 cells/mm3 or platelets \< 100 000 cells/mm3 or hemoglobin \< 90g/L), measured within 4 weeks of registration
AST, ALT or total bilirubin > 2.5 times the upper limit of normal, measured within 4 weeks of registration
Unintentional weight loss >10% over 3 months within 4 weeks of registration
Severe active co-morbidity defined by:
Significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction
Transmural myocardial infection requiring intravenous antibiotics at the time of registration
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization
Acquired immune deficiency syndrome (AIDS) based on the current Centre for Disease Control definition; note, however, that HIV testing is not required for entry into this protocol

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 78 participants (estimated)

Study arms

Active comparator
Chemoradiotherapy
Patients randomized to the standard arm will receive radiotherapy (5x per week) of 60 gray (Gy) in 30 fractions with concurrent cisplatin and etoposide chemotherapy.
Radiation: Chemoradiotherapy
Experimental
Chemoradiotherapy with Integrated Boost Dose
Patients randomized to the experimental arm will receive radiotherapy (5x per week) with an integrated boost dose of up to 85Gy in 30 fractions to tumor subvolumes, with concurrent cisplatin and etoposide chemotherapy.
Radiation: Chemoradiotherapy with Integrated Boost Dose

Interventions

RadiationChemoradiotherapy
Patients will receive radiotherapy of 60Gy in 30 fractions (5x per week) with concurrent cisplatin and etoposide chemotherapy.
RadiationChemoradiotherapy with Integrated Boost Dose
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.

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

7 sites

Kingston General Hospital
Kingston, Ontario K7L 2V7, Canada
London Regional Cancer Program
London, Ontario N6A 4L6, Canada
Stronach Regional Cancer Centre at Southlake Regional Health Centre
Newmarket, Ontario L3Y 2P9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9, Canada
McGill University Health Centre, Glen site Cedars Cancer Center
Montreal, Quebec H4A 3J1, Canada
CHU de Quebec - L'Hôtel-Dieu de Québec
Québec, Quebec G2L 2Z3, Canada
CHUS - Hôpital Fleurimont
Sherbrooke, Quebec J1H 5N4, Canada

References and documents

Publications

Raman S, Bissonnette JP, Warner A, Le L, Bratman S, Leighl N, Bezjak A, Palma D, Schellenberg D, Sun A. 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). Clin Lung Cancer. 2018 Sep;19(5):e699-e703. doi: 10.1016/j.cllc.2018.05.002. Epub 2018 May 16. PubMed 29903551 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02788461
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Responsible party: David Palma (Principal Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Principal investigator
First posted: Jun 2, 2016
Start date: May 2016
Primary completion: Apr 2026 (estimated)
Completion: Apr 2026 (estimated)
Last update: Sep 18, 2025

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma, Non-Small-Cell Lung→

Other studies from this sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Start the discussion