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

NCT00136890 | Completed Phase 3 DMC

• 1 other identifier: CTA-Control-088145
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 8

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

Keywords

Positron-Emission Tomography; PET Scan; Lung Cancer; Thoracic Surgery; Diagnostic; Randomized Controlled Trial; Oncology

Outcome Measures

Primary Outcomes (1)

• Patients correctly upstaged by PET versus conventional staging

  November 2007

Secondary Outcomes (5)

• 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

Study Arms (2)

1

NO INTERVENTION

Conventional Staging

2

EXPERIMENTAL

PET Imaging

Procedure: PET Imaging

Interventions

PET Imaging PROCEDURE

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (8)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Credit Valley

Mississauga, Ontario, L5M 2N1, Canada

Location

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Scarborough Hospital

Scarborough Village, Ontario, M1P 2T7, Canada

Location

Sunnybrook/TEGH

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

St. Joseph's Health Care

Toronto, Ontario, M6R 1B5, Canada

Location

Related Publications (1)

• 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.

  PMID: 19581636 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Disease; Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Donna E Maziak, MD

  The Ottawa Hospital

  STUDY CHAIR

• Gail E Darling, MD

  Toronto General Hospital

  STUDY CHAIR

• Mark N Levine, MD

  Ontario Clinical Oncology Group (OCOG)

  PRINCIPAL INVESTIGATOR

• William Evans, MD

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 29, 2005
• Study Start: July 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: January 1, 2013
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

CA (8)