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

Phase 3

Completed

• Conditions: Non-small-cell Lung Carcinoma
• Interventions: Procedure: PET Imaging

• Registration Number: NCT00136890
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-29
• Primary Completion: 2008-11
• Status Verified: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	PET Imaging	PET Imaging

Primary Outcome Measures

Name	Time	Method
Patients correctly upstaged by PET versus conventional staging	November 2007

Secondary Outcome Measures

Name	Time	Method
Patients erroneously understaged by PET versus conventional staging	November 2008
Overall survival	August 2012
Prognostic ability of PET standard uptake value	August 2011
Sensitivity and specificity of PET in the mediastinum	November 2008
Cost-effectiveness of using PET versus conventional staging	August 2012

Trial Locations

Locations (8)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook/TEGH; 🇨🇦 Toronto, Ontario, Canada

The Ottawa Hospital - General Campus; 🇨🇦 Ottawa, Ontario, Canada

St. Joseph's Health Care; 🇨🇦 Toronto, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Credit Valley; 🇨🇦 Mississauga, Ontario, Canada

Scarborough Hospital; 🇨🇦 Scarborough, Ontario, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada