Clinical trial NCT02788461: Assessing the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction of local-regional failure rate
timeFrame: 2 years
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
measure: Grade 3-5 Toxicity Rate
timeFrame: 2 years
measure: Quality of Life FACT-L
timeFrame: 2 years
measure: Quality of Life EQ-5D
timeFrame: 2 years
measure: Dose-Response Characterization
timeFrame: 2 years
measure: Dose Escalation Feasibility
timeFrame: 2 weeks
measure: Imaging Use
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Newmarket,
country: Canada
facility: Stronach Regional Cancer Centre at Southlake Regional Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ont
city: Montreal,
country: Canada
facility: McGill University Health Centre, Glen site Cedars Cancer Center
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hôpital Fleurimont
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - L'Hôtel-Dieu de Québec
Study officials:
References:
citation: 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.