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| Sponsor: | Ontario Clinical Oncology Group (OCOG) |
|---|---|
| Collaborator: |
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 Imaging |
Phase III |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, 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 |
| Enrollment: | 337 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: No Intervention
Conventional Staging
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2: Experimental
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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| The Ottawa Hospital - General Campus | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4G5 | |
| St. Joseph's Healthcare Hamilton | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Sunnybrook/TEGH | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Scarborough Hospital | |
| Scarborough, Ontario, Canada, M1P 2T7 | |
| St. Joseph's Health Care | |
| Toronto, Ontario, Canada, M6R 1B5 | |
| Credit Valley | |
| Mississauga, Ontario, Canada, L5M 2N1 | |
| 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 |
| Principal Investigator: | William Evans, MD | Juravinski Cancer Centre |
More Information
| Responsible Party: | Ontario Clinical Oncology Group ( Dr. Mark Levine/Director OCOG ) |
| Study ID Numbers: | CTA-Control-088145 |
| Study First Received: | August 25, 2005 |
| Last Updated: | October 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00136890 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Positron-Emission Tomography PET Scan Lung Cancer Thoracic Surgery |
Diagnostic Randomized Controlled Trial Oncology |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |