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PET Imaging in Potentially Surgically Resectable Non-small Cell Lung Cancers (ELPET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00136890
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : January 15, 2013
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Non-small-cell Lung Carcinoma Procedure: PET Imaging Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 337 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : July 2004
Actual Primary Completion Date : November 2008
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: 1
Conventional Staging
Experimental: 2
PET Imaging
 Procedure: PET Imaging
Patients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI)


Outcome Measures
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Primary Outcome Measures :
  1. Patients correctly upstaged by PET versus conventional staging [ Time Frame: November 2007 ]

Secondary Outcome Measures :
  1. Patients erroneously understaged by PET versus conventional staging [ Time Frame: November 2008 ]
  2. Overall survival [ Time Frame: August 2012 ]
  3. Prognostic ability of PET standard uptake value [ Time Frame: August 2011 ]
  4. Sensitivity and specificity of PET in the mediastinum [ Time Frame: November 2008 ]
  5. Cost-effectiveness of using PET versus conventional staging [ Time Frame: August 2012 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136890


Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Credit Valley
Mississauga, Ontario, Canada, L5M 2N1
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Scarborough Hospital
Scarborough, Ontario, Canada, M1P 2T7
Sunnybrook/TEGH
Toronto, Ontario, Canada, M4N 3M5
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
St. Joseph's Health Care
Toronto, Ontario, Canada, M6R 1B5
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Ontario Ministry of Health and Long Term Care
Investigators
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Study Chair: Donna E Maziak, MD The Ottawa Hospital
Study Chair: Gail E Darling, MD Toronto General Hospital
Principal Investigator: Mark N Levine, MD Ontario Clinical Oncology Group (OCOG)
Principal Investigator: William Evans, MD Juravinski Cancer Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00136890    
Other Study ID Numbers: CTA-Control-088145
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013
Keywords provided by Ontario Clinical Oncology Group (OCOG):
Positron-Emission Tomography
PET Scan
Lung Cancer
Thoracic Surgery
 Diagnostic
Randomized Controlled Trial
Oncology
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms