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

NCT ID: NCT00136890

Last Updated: 2013-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 337 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2013-01-31

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.

Conditions

Non-small-cell Lung Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Conventional Staging

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

PET Imaging

Group Type: EXPERIMENTAL

PET Imaging

Intervention Type: PROCEDURE

Patients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI)

Interventions

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)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role: collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donna E Maziak, MD

Role: STUDY_CHAIR

The Ottawa Hospital

Gail E Darling, MD

Role: STUDY_CHAIR

Toronto General Hospital

Mark N Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Ontario Clinical Oncology Group (OCOG)

William Evans, MD

Role: PRINCIPAL_INVESTIGATOR

Juravinski Cancer Centre

Locations

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 Village, Ontario, Canada

Sunnybrook/TEGH

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

St. Joseph's Health Care

Toronto, Ontario, Canada

Countries

Canada

References

Maziak DE, Darling GE, Inculet RI, Gulenchyn KY, Driedger AA, Ung YC, Miller JD, Gu CS, Cline KJ, Evans WK, Levine MN. Positron emission tomography in staging early lung cancer: a randomized trial. Ann Intern Med. 2009 Aug 18;151(4):221-8, W-48. doi: 10.7326/0003-4819-151-4-200908180-00132. Epub 2009 Jul 6.

Reference Type: DERIVED

PMID: 19581636 (View on PubMed)

Other Identifiers

CTA-Control-088145

Identifier Type: -

Identifier Source: org_study_id