Status:
COMPLETED
PET Imaging in Potentially Surgically Resectable Non-small Cell Lung Cancers
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Ontario Ministry of Health and Long Term Care
Conditions:
Non-small-cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT00136890
Start Date
July 1 2004
End Date
January 1 2013
Last Update
January 15 2013
Active Locations (8)
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1
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
2
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
3
Credit Valley
Mississauga, Ontario, Canada, L5M 2N1
4
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6