Condition category
Cancer
Date applied
05/11/2007
Date assigned
05/11/2007
Last edited
13/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mark N. Levine

ORCID ID

Contact details

Ontario Clinical Oncology Group (OCOG)
711 Concession St
Hamilton
Ontario
L8V 1C3
Canada
mlevine@mcmaster.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00136890

Protocol/serial number

MCT-78777

Study information

Scientific title

Acronym

ELPET Trial

Study hypothesis

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

Research Ethics Board of University Health Networks, Toronto, Ontario, Canada approved on the 12th March 2004 (ref: 04-0006-C).

Study design

Multicentre, two arm, randomised parallel trial exploring diagnostic strategy

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Stage I, II, IIIA Non-small Cell Lung Cancer

Intervention

PET Imaging versus Conventional Staging.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/07/2004

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

322

Participant 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

Recruitment start date

01/07/2004

Recruitment end date

31/07/2011

Locations

Countries of recruitment

Canada

Trial participating centre

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

Sponsor information

Organisation

McMaster University (Canada)

Sponsor details

c/o Ms Debbie Billings
Department of Clinical Epidemiology and Biostatistics
HSC 2C4
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 525 9140 ext. 22665
billings@mcmaster.ca

Sponsor type

University/education

Website

http://www.mcmaster.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-78777)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19581636

Publication citations

  1. Results

    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, 151, 4, 221-8, W-48.

Additional files

Editorial Notes