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Non-Small Cell Lung CancerPET-BOOSTNCT02788461

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

A study testing Chemoradiotherapy and Chemoradiotherapy with Integrated Boost Dose in people with Non-Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 7 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Chemoradiotherapy and Chemoradiotherapy with Integrated Boost Dose
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
7 sitesCanada
Study dates
May 2016to Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • McGill University Health Centre, Glen site Cedars Cancer Center

    Montreal, Quebec, H4A 3J1

  • Stronach Regional Cancer Centre at Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

  • CHU de Quebec - L'Hôtel-Dieu de Québec

    Québec, Quebec, G2L 2Z3

  • CHUS - Hôpital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: 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

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.

Being tested
Chemoradiotherapy, Chemoradiotherapy with Integrated Boost Dose
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChemoradiotherapyRadiation

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

  • Chemoradiotherapy with Integrated Boost DoseRadiation

    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.

Study groups in NCT02788461
Study groupRoleWhat they receive
ChemoradiotherapyActive comparatorPatients randomized to the standard arm will receive radiotherapy (5x per week) of 60 gray (Gy) in 30 fractions with concurrent cisplatin and etoposide chemotherapy.
Receives: Radiation: Chemoradiotherapy
Chemoradiotherapy with Integrated Boost DoseExperimentalPatients 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.
Receives: Radiation: Chemoradiotherapy with Integrated Boost Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

Secondary outcomes (8)

  1. Progression-Free Survival

    Determine if dose escalation to metabolically active subvolumes will improve progression-free survival at 2 years

    Measured: 2 years

  2. Overall Survival

    Determine if dose escalation to metabolically active subvolumes will improve overall survival at 2 years

    Measured: 2 years

  3. Grade 3-5 Toxicity Rate

    Determine if dose escalation to metabolically active subvolumes will increase the rate of grade 3-5 toxicities

    Measured: 2 years

  4. Quality of Life FACT-L

    Compare the quality of life in the two arms using Functional Assessment of Cancer Therapy-Lung (FACT-L) instrument

    Measured: 2 years

  5. Quality of Life EQ-5D

    Compare the quality of life in the two arms using EuroQol Quality of Life-5 Dimensions (EQ-5D) instrument

    Measured: 2 years

  6. 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

    Measured: 2 years

  7. Dose Escalation Feasibility

    Explore the feasibility of adaptive dose escalation based on PET response at week 2

    Measured: 2 weeks

  8. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02788461
Sponsor's protocol ID
PET-BOOST NSCLC
Acronym
PET-BOOST
Status last verified
Sep 2025
First submitted
28 Apr 2016
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Chemoradiotherapy and Chemoradiotherapy with Integrated Boost Dose in people with Non-Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of local-regional failure rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02788461, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

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