Clinical trial NCT00984243: Photodynamic Therapy (PDT) in Lung Cancer
Official title: An Evaluation of the Effectiveness of Photodynamic Therapy (PDT) Compared to Surgical Resection in Early Stage Roentgenographically Occult Lung Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-09-25
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the impact of PDT on these patients by determining the percentage of patients who are spared surgery.
timeFrame: 3 years
Secondary outcomes:
measure: Morbidity,overall mortality and lung cancer mortality.
timeFrame: 3 years
measure: Rate of subsequent lung cancer.
timeFrame: 3 years
measure: Relative cost of PDT and surgery.
timeFrame: 3 years
measure: Change in pulmonary function over time.
timeFrame: 3 years
measure: Effect on quality of life.
timeFrame: 3 years
measure: Patient preferences for PDT and surgery.
timeFrame: 3 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Eric S. Edell, M.D.
role: PRINCIPAL_INVESTIGATOR
References: