Randomized Study of Positron Emission Tomography - Computed Tomography (PET/CT) in Pre-Operative Staging of Lung Cancer
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867412
|PET & Cyclotron Unit, Rigshospitalet,|
|Copenhagen, Denmark, 2100|