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)
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
Allocation: Randomized, Primary Purpose: Diagnostic
Mary O'Brien, MD
Royal Marsden NHS Foundation Trust
United States: Federal Government