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

Non-small-cell Lung Carcinoma Clinical Trial

— ELPET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136890
• Other study ID #: CTA-Control-088145
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2005
• Last updated: January 14, 2013
• Start date: July 2004
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: January 2013
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Carcinoma

Intervention

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)

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Credit Valley	Mississauga	Ontario
Canada	The Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	Scarborough Hospital	Scarborough	Ontario
Canada	St. Joseph's Health Care	Toronto	Ontario
Canada	Sunnybrook/TEGH	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients correctly upstaged by PET versus conventional staging		November 2007	No
Secondary	Patients erroneously understaged by PET versus conventional staging		November 2008	No
Secondary	Overall survival		August 2012	No
Secondary	Prognostic ability of PET standard uptake value		August 2011	No
Secondary	Sensitivity and specificity of PET in the mediastinum		November 2008	No
Secondary	Cost-effectiveness of using PET versus conventional staging		August 2012	No