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NCT02788461Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
78 (estimated)
First submitted
28 Apr 2016
Start date
May 2016
Primary completion date
Apr 2026
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Diseases
Lung cancer
NCT number
NCT02788461

What you commit to

  • Study type: Interventional
  • Planned participants: 78
  • From May 2016 to the primary completion date, Apr 2026
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Trimodality patients who have surgery as part of curative treatment
  • Previous radiotherapy to intended treatment volumes
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization

Other illness

  • Active invasive malignancy other than lung cancer
  • Transmural myocardial infection requiring intravenous antibiotics at the time of registration
  • 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

Lab values

  • 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
  • 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

Age

  • Poor respiratory function (Forced Expiratory Volume \< 1.0 or Diffusing Capacity \< 50% age-adjusted normal)

Other

  • Active pregnancy
  • ECOG status \> 2
  • Unintentional weight loss \>10% over 3 months within 4 weeks of registration
  • Severe active co-morbidity defined by:

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kingston General Hospital
Coordinator of this site? Confirm its status
KingstonCanadaUnknown status
London Regional Cancer Program
Coordinator of this site? Confirm its status
LondonCanadaUnknown status
McGill University Health Centre, Glen site Cedars Cancer Center
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Stronach Regional Cancer Centre at Southlake Regional Health Centre
Coordinator of this site? Confirm its status
NewmarketCanadaUnknown status
CHU de Quebec - L'Hôtel-Dieu de Québec
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
CHUS - Hôpital Fleurimont
Coordinator of this site? Confirm its status
SherbrookeCanadaUnknown status
Princess Margaret Cancer Centre
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.