An Evaluation of the Effectiveness of Photodynamic Therapy (PDT) Compared to Surgical Resection in Early Stage Roentgenographically Occult Lung Cancer.
50 Years
75 Years
Both
Lung Cancer
Trial Information
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.
Inclusion Criteria:
- Patient less than 75 years of age.
- Squamous cell lung cancer proven by biopsy or repeated Brushings obtained from the
same location at separate bronchoscopies.
- Occult lung cancer by chest roentgenogram and CT scan If CT scan is abnormal,
mediastinoscopy is negative.
- Cancer is bronchoscopically superficial as defined in section IV, E.
- Estimated size less than 1 cm diameter on the surface of the bronchus with the
surface area of 0.7 to 1.0 cm2.
- Location in the trachea, main stem bronChi, lobar bronchi, segmental bronchi, or
subsegmental bronchi.
- Medical condition permits surgery: cardiovascular status is satisfactory for
operation and postoperative FEVl is predicted to be greater than 0.75 liter.
- Patients will complete quality of life questionnaire and a spirometry which will
include forced expiratory volume in 1 second (FEVl) and forced vital capacity (FVC).
- On bronchoscopic biopsy, the carcinoma is entirely in situ or shows no more than 2 mm
of microinvasion.
- The characteristics of the mucosa. may include paleness, opacity, loss of luster,
roughness, micro-granularity.
- The mucosal folds may demonstrate lack of clarity. thickening, disappearance.
- There may be small nodular protrusion of tumor into the lumen
- The peripheral extent of tumor invasion can be confirmed endoscopically.
Exclusion Criteria:
- A medical disease which excludes surgery as an option
- A postoperative FEVl predicted to be less than 0.75 liter
- A previous carcinoma or other malignancy not curatively treated
- The presence of simultaneous lung cancers
- CT scan of the chest shows thickening of the bronchial wall or extension beyond the
bronchial wall in the area of the cancer
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Evaluate the impact of PDT on these patients by determining the percentage of patients who are spared surgery.
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Eric S. Edell, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
281-92
NCT ID:
NCT00984243
Start Date:
February 1994
Completion Date:
October 2006
Related Keywords:
- Lung Cancer
- lung cancer
- Lung Neoplasms
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
