Photodynamic Therapy (PDT) in 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||An Evaluation of the Effectiveness of Photodynamic Therapy (PDT) Compared to Surgical Resection in Early Stage Roentgenographically Occult Lung Cancer.|
- Evaluate the impact of PDT on these patients by determining the percentage of patients who are spared surgery. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Morbidity,overall mortality and lung cancer mortality. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Rate of subsequent lung cancer. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Relative cost of PDT and surgery. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Change in pulmonary function over time. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Effect on quality of life. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Patient preferences for PDT and surgery. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 1994|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Experimental: Photodynamic Therapy
PHOTODYNAMIC THERAPY (PDT)
Procedure: PHOTODYNAMIC THERAPY (PDT)
Photofrin II will be injected at a dosage of 2 mm/Kg intravenously. Laser treatment will take place 40-50 hours later. An argon-dye or an excimer-dye laser tuned to 620-630 nm will be used.
It is anticipated that a microlens fiber will be used in almost all cases, but a cylinder-diffusing fiber can be used to treat lesions in segmental bronchi if needed.
Argon-dye laser: Power settings 200 milliwatt (mW) microlens and 400 mW for cylinder Excimer laser: 4 milliJoules (mJoules)/pulse at 30 hertz for the microlens
Argon-dye laser: 200-300 Joules/cm^2 Excimer-dye laser: 100-200 Joules/cm^2
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984243
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Eric S. Edell, M.D.||Mayo Clinic|