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 (NCT)	NCT00136890
Protocol serial number	MCT-78777
Sponsor	McMaster University (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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

Ontario Clinical Oncology Group (OCOG)
711 Concession St
Hamilton, Ontario
L8V 1C3
Canada

Email	mlevine@mcmaster.ca

Study information

Primary study design	Interventional
Study design	Multicentre, two arm, randomised parallel trial exploring diagnostic strategy
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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