Randomized Study of Positron Emission Tomography - Computed Tomography (PET/CT) in Pre-Operative Staging of Lung Cancer
Patients with possible operable non-small cell lung cancer are randomised to conventional staging, or conventional staging and PET/CT. According to, patients with operable tumor will be referred to surgery, and the number of thoracotomies and futile thoracotomies wil be compared with the two groups in order to asses the possible benefit of PET/CT.
Non-Small Cell Lung Cancer
|Study Design:||Time Perspective: Prospective|
|Official Title:||Randomized Study of PET/CT in Pre-Operative Staging of Lung Cancer|
- Number of futile thoracotomies [ Time Frame: Within 1 year ] [ Designated as safety issue: Yes ]
- Number of thoracotomies and survival [ Time Frame: Within 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2002|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
Staging with CT, mediastinoscopy and bronchoscopy
Conventional staging and PET/CT
Staging with CT, mediastinoscopy and bronchoscopy, and PET/CT performed prior to mediastinoscopy
Patients with possible operable NSCLC after staging with CT are randomised to PET-CT with FDG or not, prior to mediastinoscopy. All patients are referred to mediastinoscopy unless a positive FDG uptake results in a positive biopsy suggesting stage IV disease.
Biopsies are performed according to the following criteria:
- Lymph nodes are numbered according the Mountain classification, and abnormal lesions must be confirmed histologically, by mediastinoscopy or thoracotomy.
- PET-positive lesions in the liver must be biopsied unless ultrasound or MRI unequivocally indicate the lesions are benign cysts or haemangioma.
- PET-negative adrenal lesions are accepted without biopsy if CT scan indicate the lesion is a benign adenoma.
- PET-positive bone lesions must be evaluated by plain x-ray, CT, MRI, or bone scintigraphy. In case of equivocal findings a biopsy must be performed.
- PET-positive brain lesions must be confirmed by CT or MRI.
Number of patients:
Patients with clinically operable NSCLC after CT-staging are included. All patients must have mediastinoscopy performed.
All patients referred to mediastinoscopy can be randomised after informed consent. A total of 430 consecutive, non-selected patients are planned. It is anticipated that approximately 60% of the referred patients with clinical stage I-IIIa NSCLC will undergo thoracotomy, and a risk of type I and II error of 5% and 10%, respectively, is accepted. Thus a total of 215 patients are randomised in each arm in order to observe an absolute difference of 15% in the number of thoracotomies. This number seems to be sufficient to evaluate differences in the secondary endpoints.
After inclusion of a total of 220 patients, corresponding to 110 PET-scans, an interim analyses are performed. In case of a highly significant difference in the number of thoracotomies (p < 0,001) the study will be closed.