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
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kingston General Hospital Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| London Regional Cancer Program Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| McGill University Health Centre, Glen site Cedars Cancer Center Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Stronach Regional Cancer Centre at Southlake Regional Health Centre Coordinator of this site? Confirm its status | Newmarket | Canada | Unknown status |
| CHU de Quebec - L'Hôtel-Dieu de Québec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| CHUS - Hôpital Fleurimont Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.