Clinical Trial: PET Imaging in Potentially Surgically Resectable Non-Small Cell Lung Cancers (ELPET Trial)

This study is currently recruiting patients.
Verified by Ontario Clinical Oncology Group (OCOG) August 2005

Sponsors and Collaborators: Ontario Clinical Oncology Group (OCOG)
Ontario Ministry of Health and Long Term Care
Information provided by: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00136890

Purpose

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 Intervention Phase
Non-Small-Cell Lung Carcinoma
 Procedure: PET Diagnostic Imaging
Phase III

MedlinePlus related topics:  Cancer;   Lung Cancer

Study Type: Interventional
Study Design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: Patients correctly upstaged by PET vs Conventional Staging
Secondary Outcomes: Pts erroneously understaged by PET vs Conventional Staging; Overall survival; Prognostic ability of PET Standard Uptake Value; Sensitivity & specificity of PET in the mediastinum; Cost-effectiveness of using PET vs Conventional Staging
Expected Total Enrollment:  322

Study start: July 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  1. Histological or cytological proof of NSCLC
  2. Stage I, II, or IIIA NSCLC based upon clinical staging
  3. The primary lesion appears technically appropriate for surgical resection, based on information from the CXR and CT thorax
  4. Age over 18 years

Exclusion Criteria:

  1. Poor pulmonary function precluding radical surgery (inadequate pulmonary reserve for radical surgery) with predicted post-resection FEV1 < 0.8 liter or < 40% predicted, and DLCO < 40 % predicted
  2. Poor performance status (ECOG 3-4)
  3. Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease) making the patient unfit for surgery
  4. Pregnant or lactating females
  5. Unable to lie supine for imaging with PET
  6. 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
  7. 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.
  8. Failure to provide informed consent

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00136890

Andrea Ling, B.Sc.      905-527-2299  Ext. 42650    linga@mcmaster.ca
Laura Bonilla, M.Sc.      905-527-2299  Ext. 42610    bonilla@mcmaster.ca

Canada, Ontario
      Toronto General Hospital, Toronto,  Ontario,  M5G 2C4,  Canada; Recruiting
Gail E Darling, MD  416-340-3121    gail.darling@uhn.on.ca 
Gail E Darling, MD,  Principal Investigator

      The Ottawa Hospital - General Campus, Ottawa,  Ontario,  K1H 8L6,  Canada; Recruiting
Donna E Maziak, MD  613-737-8899  Ext. 74035    dmaziak.ohri.ca 
Donna E Maziak, MD,  Principal Investigator

      London Health Sciences Centre, London,  Ontario,  N6A 4G5,  Canada; Recruiting
Richard I Inculet, MD  519-667-6679    rinculet@lhsc.on.ca 
Richard I Inculet, MD,  Principal Investigator

      St. Joseph''''s Healthcare Hamilton, Hamilton,  Ontario,  L8N 4A6,  Canada; Recruiting
John Miller, MD  905-522-1155  Ext. 6126    jmiller@mcmaster.ca 
John Miller, MD,  Principal Investigator

Study chairs or principal investigators

Donna E Maziak, MD,  Study Chair,  The Ottawa Hospital   
Gail E Darling, MD,  Study Chair,  Toronto General Hospital   
Mark N Levine, MD,  Principal Investigator,  Ontario Clinical Oncology Group   
William Evans, MD,  Principal Investigator,  Juravinski Cancer Centre   

More Information

Study ID Numbers:  CTA-Control-088145
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00136890
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-30

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