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Photodynamic Therapy (PDT) in Lung Cancer (PDT)

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ClinicalTrials.gov Identifier: NCT00984243
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : November 15, 2012
Sponsor:
Information provided by:
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE December 24, 2007
First Posted Date  ICMJE September 25, 2009
Last Update Posted Date November 15, 2012
Study Start Date  ICMJE February 1994
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2009)
Evaluate the impact of PDT on these patients by determining the percentage of patients who are spared surgery. [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00984243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2009)
  • Morbidity,overall mortality and lung cancer mortality. [ Time Frame: 3 years ]
  • Rate of subsequent lung cancer. [ Time Frame: 3 years ]
  • Relative cost of PDT and surgery. [ Time Frame: 3 years ]
  • Change in pulmonary function over time. [ Time Frame: 3 years ]
  • Effect on quality of life. [ Time Frame: 3 years ]
  • Patient preferences for PDT and surgery. [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photodynamic Therapy (PDT) in Lung Cancer
Official Title  ICMJE An Evaluation of the Effectiveness of Photodynamic Therapy (PDT) Compared to Surgical Resection in Early Stage Roentgenographically Occult Lung Cancer.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Lung Cancer
Intervention  ICMJE Procedure: PHOTODYNAMIC THERAPY (PDT)

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

Study Arms  ICMJE Experimental: Photodynamic Therapy
PHOTODYNAMIC THERAPY (PDT)
Intervention: Procedure: PHOTODYNAMIC THERAPY (PDT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2012)
35
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2009)
100
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00984243
Other Study ID Numbers  ICMJE 281-92
PulmMed 649
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric S. Edell, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric S. Edell, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP