Clinical trial NCT00136890: PET Imaging in Potentially Surgically Resectable Non-small Cell Lung Cancers
Official title: The Impact of Positron Emission Tomography (PET) Imaging in Staging Potentially Surgically Resectable Non-small Cell Lung Cancers: A Prospective Multicentre Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small-cell Lung Carcinoma
Keywords: Positron-Emission Tomography
PET Scan
Lung Cancer
Thoracic Surgery
Diagnostic
Randomized Controlled Trial
Oncology
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2005-08-29
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Lung cancer remains the leading cause of cancer deaths in men and women. Although overall survival remains poor, early stage non-small cell lung cancer (NSCLC) is potentially curable. Improved staging has led to stage-specific therapies such that patients with early stage NSCLC are potential candidates for surgical resection, and those with more advanced disease are spared the morbidity and risk of mortality from thoracotomy and pulmonary resection. Despite contemporary staging techniques, 25-50% of patients who appear to have limited disease amenable to surgical resection go on to die from metastatic lung cancer. If occult micro-metastatic disease that becomes evident later could be detected reliably during the pre-operative assessment, patients harboring such disease could be spared a non-curative thoracotomy. PET imaging has the potential to detect mediastinal and extrathoracic metastatic disease not detected by conventional imaging modalities.

This prospective, multicenter trial will enroll patients with biopsy-proven clinical stage I-IIIA NSCLC who are considered to be candidates for surgical resection with curative intent. Preoperatively, patients will be randomized to conventional staging for metastatic disease (CT liver/adrenals, total body bone scan, and CT with contrast or MRI with gadolinium of the brain) versus whole body PET or PET-CT and brain CT or MRI with contrast/gadolinium.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological proof of NSCLC
* Stage I, II, or IIIA NSCLC based upon clinical staging
* The primary lesion appears technically appropriate for surgical resection, based on information from the chest x-ray (CXR) and CT thorax.
* Age over 18 years

Exclusion Criteria:

* Poor pulmonary function precluding radical surgery (inadequate pulmonary reserve for radical surgery) with predicted post-resection forced expiratory volume in 1 second (FEV1) \< 0.8 liter or \< 40% predicted, and diffusing capacity of the lung for carbon monoxide (DLCO) \< 40% predicted
* Poor performance status (Eastern Cooperative Oncology Group \[ECOG\] 3-4)
* Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease) making the patient unfit for surgery
* Pregnant or lactating females
* Unable to lie supine for imaging with PET
* Patients with previously treated cancer other than non-melanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater
* Patients who, at the time of the initial evaluation, have already undergone a whole body PET/PET-CT, CT brain, MRI brain, total body bone scan or mediastinoscopy within 8 weeks prior to randomization will be excluded. However, patients who have had a CT scan of the thorax with abdomen are not excluded.
* Failure to provide informed consent

Primary outcomes:
measure: Patients correctly upstaged by PET versus conventional staging
timeFrame: November 2007
Secondary outcomes:
measure: Patients erroneously understaged by PET versus conventional staging
timeFrame: November 2008
measure: Overall survival
timeFrame: August 2012
measure: Prognostic ability of PET standard uptake value
timeFrame: August 2011
measure: Sensitivity and specificity of PET in the mediastinum
timeFrame: November 2008
measure: Cost-effectiveness of using PET versus conventional staging
timeFrame: August 2012
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook/TEGH
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Donna E Maziak, MD
role: STUDY_CHAIR
affiliation: Toronto General Hospital
name: Gail E Darling, MD
role: STUDY_CHAIR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark N Levine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Juravinski Cancer Centre
name: William Evans, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maziak DE, Darling GE, Inculet RI, Gulenchyn KY, Driedger AA, Ung YC, Miller JD, Gu CS, Cline KJ, Evans WK, Levine MN. Positron emission tomography in staging early lung cancer: a randomized trial. Ann Intern Med. 2009 Aug 18;151(4):221-8, W-48. doi: 10.7326/0003-4819-151-4-200908180-00132. Epub 2009 Jul 6.