An Evaluation of the Effectiveness of Photodynamic Therapy (PDT) Compared to Surgical Resection in Early Stage Roentgenographically Occult Lung Cancer.
Lung cancer is currently the leading cause of death in both women and men in the United
States and continues to be a major problem in several other countries in the world.
Detection, localization, and surgical treatment at an early stage, provides the best
opportunity for long-term survival for patients with non-sma11 cell lung cancer at this
time. Studies examining the utility of screening patients at high risk for lung cancer with
sputum cytology and chest roentgenograms showed that, despite a higher frequency of
detecting and resecting early cancers in the screened group, there was no difference between
the screened group and the control group in overall cancer mortality.
The purpose of this study is to determine if photodynamic therapy (PDT) is an alternative to
surgical resection in patients with early stage) roentgenographically occult squamous cell
carcinoma of the lung who are candidates for surgery. If PDT is successful, it would remove
the indication for surgery and eliminate the need for an operation. The specific goals are
to evaluate the impact of PDT on these patients by determining the percentage of patients
who are spared surgery as wel1 as the following: morbidity, overall mortality, lung cancer
mortality, the rate of subsequent lung cancer, the relative cost of PDT and surgery, the
change in pulmonary function over time, the effect on quality of life, and the patient
preferences for PDT and surgery.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Evaluate the impact of PDT on these patients by determining the percentage of patients who are spared surgery.
Eric S. Edell, M.D.
United States: Food and Drug Administration
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