Lung Cancer Clinical Trial
Official title:
An Evaluation of the Effectiveness of Photodynamic Therapy (PDT) Compared to Surgical Resection in Early Stage Roentgenographically Occult Lung Cancer.
This study is being done to determine whether a substance called hematoporphyrin can be used to treat tumors in various locations in the body when used in association with a laser. Hematoporphyrin is a substance that is taken up by cancerous cells. When these cells are exposed to the energy emitted by a laser source, chemical reactions occur in the cell and cause the cells to die. It is hoped that this treatment method may be able to selectively destroy malignant cells without damaging surrounding healthy tissue.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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