Back to results

Photodynamic Therapy (PDT) in Lung Cancer (PDT)

Primary Purpose

Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PHOTODYNAMIC THERAPY (PDT)

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring lung cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Photodynamic Therapy

Arm Description

PHOTODYNAMIC THERAPY (PDT)

Outcomes

Primary Outcome Measures

Evaluate the impact of PDT on these patients by determining the percentage of patients who are spared surgery.

Secondary Outcome Measures

Morbidity,overall mortality and lung cancer mortality.

Rate of subsequent lung cancer.

Relative cost of PDT and surgery.

Change in pulmonary function over time.

Effect on quality of life.

Patient preferences for PDT and surgery.

Full Information

NCT ID

NCT00984243

First Posted

December 24, 2007

Last Updated

November 13, 2012

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00984243

Brief Title

Photodynamic Therapy (PDT) in Lung Cancer

Acronym

PDT

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

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

February 1994 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

lung cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Photodynamic Therapy

Arm Type

Experimental

Arm Description

PHOTODYNAMIC THERAPY (PDT)

Intervention Type

Procedure

Intervention Name(s)

PHOTODYNAMIC THERAPY (PDT)

Intervention Description

Photodynamic Procedure: 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 Energy density: Argon-dye laser: 200-300 Joules/cm^2 Excimer-dye laser: 100-200 Joules/cm^2

Primary Outcome Measure Information:

Title

Evaluate the impact of PDT on these patients by determining the percentage of patients who are spared surgery.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Morbidity,overall mortality and lung cancer mortality.

Time Frame

3 years

Title

Rate of subsequent lung cancer.

Time Frame

3 years

Title

Relative cost of PDT and surgery.

Time Frame

3 years

Title

Change in pulmonary function over time.

Time Frame

3 years

Title

Effect on quality of life.

Time Frame

3 years

Title

Patient preferences for PDT and surgery.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric S. Edell, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Links:

URL

http://clinicaltrials.mayo.edu

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Photodynamic Therapy (PDT) in Lung Cancer

We'll reach out to this number within 24 hrs