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NCT Number: NCT02788461

Assessing 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kingston General Hospital, Kingston, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Chemoradiotherapy

Radiation

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

Chemoradiotherapy with Integrated Boost Dose

Radiation

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.

Primary outcomes

  1. Reduction of local-regional failure rate

    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

Secondary outcomes

  1. Progression-Free Survival

    Time frame: 2 years

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

  2. Overall Survival

    Time frame: 2 years

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

  3. Grade 3-5 Toxicity Rate

    Time frame: 2 years

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

  4. Quality of Life FACT-L

    Time frame: 2 years

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

  5. Quality of Life EQ-5D

    Time frame: 2 years

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

  6. Dose-Response Characterization

    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

  7. Dose Escalation Feasibility

    Time frame: 2 weeks

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

  8. Imaging Use

    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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Acronym: PET-BOOST

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2016
Registry last updated
Sep 18, 2025

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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