The impact of Positron Emission Tomography (PET) imaging in staging potentially surgically resectable non-small cell lung cancers: a prospective, multicentre randomised clinical trial

Completed

• Conditions: Stage I, II, IIIA Non-small Cell Lung Cancer; Cancer; Malignant neoplasm of lung

• Registration Number: ISRCTN67987497
• Lead Sponsor: McMaster University (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 322

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.