Diagnosis and Treatment Planning in Patients Suspected of Having Lung Cancer
RATIONALE: Diagnostic procedures and treatment-planning systems may affect outcome in patients suspected of having lung cancer.
PURPOSE: Randomized diagnostic trial to compare the effectiveness of two types of diagnostic and treatment-planning systems in patients who are suspected of having lung cancer.
Procedure: computed tomography
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Primary Purpose: Diagnostic
|Official Title:||A Pilot Study Leading to a Randomized Trial Comparing Outcomes in Patients With Suspected Lung Cancer Investigated in the Conventional Locally (LO) Based (BA) Chest Clinic Compared With a Centralized 2 Stop Pathway (LOBA 2STOP)|
|Study Start Date:||October 1998|
OBJECTIVES: I. Compare the survival rate of patients with suspected lung cancer when diagnosed and managed using the conventional locally based approach versus a new centralized system using a 2 stop diagnosis. II. Compare the resection rate in both diagnostic arms. III. Assess the quality of service given in both diagnostic arms.
OUTLINE: This is a randomized study. Patients present to a general practitioner where they are referred to the local chest clinic. Patients are seen by the chest physician and, if deemed eligible, are randomized between 2 diagnostic arms. Arm I (Conventional Locally Based Diagnosis): Patients undergo bronchoscopy and CT scan as appropriate, and then are discussed or referred by individual chest physicians, as is the current practice. The optimal period for diagnosis and discussion of management plans is 6 weeks. Arm II (Centralized 2 Stop Diagnosis): Patients undergo CT scan the following Monday morning. The consultant radiologist advises the most appropriate diagnostic test (e.g., bronchoscopy or percutaneous needle biopsy) to be done that same Monday. A tissue diagnosis is available Thursday morning for the multidisciplinary meeting attended by the chest physician, medical and clinical oncologists, and a surgeon, and the patient treatment plan is decided. Quality of life is assessed at baseline and at 6 weeks. Patients are followed for 2 years.
PROJECTED ACCRUAL: A total of 252-315 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005071
|Royal Marsden Hospital|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Mary O'Brien, MD||Royal Marsden NHS Foundation Trust|