The impact of Positron Emission Tomography (PET) imaging in staging potentially surgically resectable non-small cell lung cancers: a prospective, multicentre randomised clinical trial
| ISRCTN | ISRCTN67987497 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67987497 |
| ClinicalTrials.gov number | NCT00136890 |
| Secondary identifying numbers | MCT-78777 |
- Submission date
- 05/11/2007
- Registration date
- 05/11/2007
- Last edited
- 13/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mark N. Levine
Scientific
Scientific
Ontario Clinical Oncology Group (OCOG)
711 Concession St
Hamilton, Ontario
L8V 1C3
Canada
| mlevine@mcmaster.ca |
Study information
| Study design | Multicentre, two arm, randomised parallel trial exploring diagnostic strategy |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | |
| Study acronym | ELPET Trial |
| Study objectives | In patients with clinical stage I - IIIA Non-Small Cell Lung Cancer (NSCLC) who are potential candidates for surgery with curative intent, to determine whether preoperative whole body PET or PET-Computed Tomography (CT) in conjunction with cranial imaging identifies more precisely those patients with occult mediastinal or extrathoracic metastatic disease, thereby sparing them from undergoing stage-inappropriate therapies, when compared to conventional preoperative staging (CT liver/adrenals, total body bone scan, CT with contrast or Magnetic Resonance Imaging [MRI] with gadolinium of the brain). |
| Ethics approval(s) | Research Ethics Board of University Health Networks, Toronto, Ontario, Canada approved on the 12th March 2004 (ref: 04-0006-C). |
| Health condition(s) or problem(s) studied | Stage I, II, IIIA Non-small Cell Lung Cancer |
| Intervention | PET Imaging versus Conventional Staging. |
| Intervention type | Other |
| Primary outcome measure | The proportion of patients in the whole body PET/PET-CT plus brain CT/MRI arm versus the conventional staging arm who are correctly upstaged to stage IIIB or IV disease prior to planned treatment, thereby sparing patients from stage-inappropriate therapy (true positives), to be measured at any time during the first 2 years of the study. |
| Secondary outcome measures | To be measured any time during the first 2 years of the study: 1. The proportion of patients in each investigational arm that were erroneously understaged and were thereby subject to potentially stage-inappropriate therapy (false negatives), either because they were eventually shown to have pathologic stage III (A or B) disease at mediastinoscopy prior to planned thoracotomy or on lymph node sampling at thoracotomy, or because they developed local recurrence or distant metastases within two years of thoracotomy (pathologic stage IV) 2. For each investigational arm, the overall survival in patients with Stage I-IIIA NSCLC who undergo surgery with curative intent 3. The prognostic ability of the PET Standard Uptake Value (SUV) to predict overall survival in patients with clinical stage I-IIIA NSCLC 4. The sensitivity and specificity of PET/PET-CT in the staging of the mediastinum, when compared to lymph node sampling at thoracotomy 5. The cost-effectiveness of staging with PET versus conventional staging |
| Overall study start date | 01/07/2004 |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 322 |
| Key inclusion criteria | 1. Histological or cytological proof of NSCLC 2. Stage I, II, or IIIA NSCLC based upon clinical staging 3. The primary lesion appears technically appropriate for surgical resection, based on information from the Chest X-Ray (CXR) and CT thorax 4. Male or female NSCLC patients, 18 years and older |
| Key exclusion criteria | 1. Poor pulmonary function precluding radical surgery (inadequate pulmonary reserve for radical surgery) with predicted post-resection Forced Exipiratory Volume in One second (FEV1) less than 0.8 l or less than 40% predicted, and Diffusing capacity of the Lung for Carbon Monoxide (DLCO) less than 40 % predicted 2. Poor performance status (Eastern Cooperative Oncology Group [ECOG] grade 3 - 4) 3. Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease) making the patient unfit for surgery 4. Pregnant or lactating females 5. Unable to lie supine for imaging with PET 6. Patients with previously treated cancer other than nonmelanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater 7. 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 randomisation will be excluded. However, patients who have had a CT scan of the thorax with abdomen are not excluded 8. Failure to provide informed consent |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- Canada
Study participating centre
Ontario Clinical Oncology Group (OCOG)
Hamilton, Ontario
L8V 1C3
Canada
L8V 1C3
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
c/o Ms Debbie Billings
Department of Clinical Epidemiology and Biostatistics, HSC 2C4
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
| Phone | +1 905 525 9140 ext. 22665 |
|---|---|
| billings@mcmaster.ca | |
| Website | http://www.mcmaster.ca/ |
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-78777)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/08/2009 | Yes | No |
