Non-small-cell Lung CarcinomaPhase 3ELPETNCT00136890
PET Imaging in Potentially Surgically Resectable Non-small Cell Lung Cancers
A Phase 3 study testing PET Imaging in people with Non-small-cell Lung Carcinoma, run by Ontario Clinical Oncology Group (OCOG) at 8 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small-cell Lung Carcinoma
- What is being tested?
- PET Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 8 sitesCanada
- Study dates
- Jul 2004to Jan 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
London Health Sciences Centre
London, Ontario, N6A 4G5
Credit Valley
Mississauga, Ontario, L5M 2N1
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Scarborough Hospital
Scarborough Village, Ontario, M1P 2T7
Sunnybrook/TEGH
Toronto, Ontario, M4N 3M5
Toronto General Hospital
Toronto, Ontario, M5G 2C4
St. Joseph's Health Care
Toronto, Ontario, M6R 1B5
About this 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
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
- Being tested
- PET Imaging
- Keywords
- Positron-Emission Tomography, PET Scan, Lung Cancer, Thoracic Surgery, Diagnostic, Randomized Controlled Trial, Oncology
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET ImagingProcedure or surgery
Patients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI)
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Conventional Staging |
| 2 | Experimental | PET Imaging Receives: Procedure: PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients correctly upstaged by PET versus conventional staging
Measured: November 2007
Secondary outcomes (5)
Patients erroneously understaged by PET versus conventional staging
Measured: November 2008
Overall survival
Measured: August 2012
Prognostic ability of PET standard uptake value
Measured: August 2011
Sensitivity and specificity of PET in the mediastinum
Measured: November 2008
Cost-effectiveness of using PET versus conventional staging
Measured: August 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startJul 2004
- Primary completionNov 2008
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small-cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- Donna E Maziak, MD, Study chair, The Ottawa HospitalGail E Darling, MD, Study chair, Toronto General HospitalMark N Levine, MD, Principal investigator, Ontario Clinical Oncology Group (OCOG)William Evans, MD, Principal investigator, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136890
- Sponsor's protocol ID
- CTA-Control-088145
- Acronym
- ELPET
- Status last verified
- Jan 2013
- First submitted
- 25 Aug 2005
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19581636
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00136890
- Acronym / sponsor ID
- ELPET / CTA-Control-088145
- Conditions
- Non-small-cell Lung Carcinoma
- Keywords
- Positron-Emission Tomography, PET Scan, Lung Cancer, Thoracic Surgery, Diagnostic, Randomized Controlled Trial, Oncology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Jul 2004
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Conventional Staging |
| 2 | Experimental | Procedure: PET ImagingPET Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET ImagingPatients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI) | Procedure or surgery | 2 |
Primary outcome
Patients correctly upstaged by PET versus conventional staging
Time frame: November 2007
5 secondary outcomes
Patients erroneously understaged by PET versus conventional staging
Time frame: November 2008
Overall survival
Time frame: August 2012
Prognostic ability of PET standard uptake value
Time frame: August 2011
Sensitivity and specificity of PET in the mediastinum
Time frame: November 2008
Cost-effectiveness of using PET versus conventional staging
Time frame: August 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
- Derived from this study: PubMed 19581636Maziak 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.
Related trials for Non-small-cell Lung Carcinoma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
RecruitingObservational study
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
HER2-mutant Advanced Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna E Maziak, MD study chair
The Ottawa Hospital
Gail E Darling, MD study chair
Toronto General Hospital
Mark N Levine, MD principal investigator
Ontario Clinical Oncology Group (OCOG)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PET Imaging in people with Non-small-cell Lung Carcinoma, run by Ontario Clinical Oncology Group (OCOG) at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients correctly upstaged by PET versus conventional staging (time frame: November 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00136890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2013.