An interventional study of Photodynamic Therapy and Argon Plasma Coagulation in Non Small Cell Lung Cancer, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
The purpose of the study is to assess the efficacy of photodynamic therapy (PDT) in relieving airway obstruction in subjects with lung cancer compared to treatment with argon plasma coagulation (APC).
This is a multi-center, randomized study that will compare the efficacy of photodynamic therapy (PDT) and argon plasma coagulation (APC) in the treatment of airway obstruction caused by non small cell lung cancer. Participants will be randomized in a 1:1 ratio to receive treatment with one of these two treatment modalities.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 3 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
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Exclusion Criteria:
Photodynamic therapy (PDT) uses activation of a photosensitizer by light of a specific wavelength to generate reactive oxygen species and singlet oxygen that causes direct cell damage and death, apoptosis, tumor vasculature damage and thrombosis, and inflammation leading to an immunological response.Following randomization, subjects will undergo treatment with either PDT or APC. Subjects will then have six additional study visits at 30, 45, 60, 90, and 180 days after their last PDT or APC treatment
Procedure: Photodynamic Therapy
Argon plasma coagulation (APC) is a noncontact form of electrocautery. Following randomization, subjects will undergo treatment with either DPT or APC. Subjects will then have six additional study visits at 30, 45, 60, 90, and 180 days after their last PDT or APC treatment.
Procedure: Argon Plasma Coagulation
Participants on this arm will be treated with photodynamic therapy. PDT is a two-stage process. The first stage of PDT is the intravenous injection of porfimer sodium (Photofrin) administered as a single slow intravenous injection over 3 to 5 minutes. The second stage involves the application of laser light to the tumor by bronchoscopy.
Participants on this arm will be treated with argon plasma coagulation. A flexible probe housing a wire delivers high-frequency, high-voltage electric current to a monopolar tungsten electrode present at the tip of the probe. Argon gas flows through the probe, and is charged or ionized to produce "plasma" as it flows around the tungsten electrode. Electric current flows through the plasma to the nearest tissue, and heat is produced as it passes through the tissue. Increased resistance created by coagulated tissue impairs the flow of electric current, and keeps the ablation depth to 1 to 2 mm.
Treatment time until failure
Measure the time until treatment failure. Treatment failure is defined in this study as the occurrence of any of the following: failure to improve airway patency, airway-re-obstruction, need for additional airway intervention, and/or worsening symptoms at 90 days after the last PDT or APC treatment .
Time frame: 90 days
Change in mean score of quality of life using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer Module (EORTC QLQ-LC13) at 30, 90 and 180 days after the last PDT or APC
QLQ-LC13 incorporates one multi-item scale to assess dyspnoea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and haemoptysis. All of the scales and single-item measures range in score from 0 to 100. A high score for the scales and single items represents a high level of symptomatology or problems.
Time frame: 30 days through 180 days
Need for additional bronchoscopic therapies for either endobronchial obstruction at the treated site or for recurrent obstruction with no additional therapies offered at 30, 90, and 180 days following the last PDT or APC treatment
This will be assessed as Yes/No at each of the time points as to whether additional bronchoscopic therapies are needed, in the opinion of the treating investigator
Time frame: 30 days through 180 days
Median survival time
The median survival time for each treatment cohort will be estimated in days after the last PDT or APC treatment using a Kaplan-Meier survival curve
Time frame: 6 months
Percent reduction in airway obstruction as measured by bronchoscopy at 30 and 90 days after the last PDT or APC treatment
Percent reduction in airway obstruction will be calculated with the formula: \[(baseline obstruction percentage - residual obstruction percentage)/baseline obstruction percentage x 100%\].
Time frame: 30 days through 90 days
Resolution of atelectasis, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment
This will be assessed by examining subject chest x-rays and/or chest CT scans at each of these time points for the presence or absence of atelectasis.
Time frame: 30 days through 180 days
Resolution of post-obstructive pneumonia, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment
This will be assessed by examining subject chest x-rays and/or chest CT scan for the presence or absence of post-obstructive pneumonia, as well as the physical examination of subjects for post-obstructive pneumonia symptoms (such as fever, pleuritic chest pain, and productive cough) at each of these time points.
Time frame: 30 days through 180 days
Change in dyspnea (as measured by the transitional dyspnea index (TDI), using the score obtained from the Baseline Dyspnea Index (BDI) as the baseline comparator) at 30, 60, 90, and 180 days after the last PDT or APC treatment
The Baseline Dyspnea Index measures the severity of dyspnea at baseline using the sum of the scores for three items that assess functional impairment and magnitude of effort required for daily activities. Total possible score ranges from 0 to 12. A lower total score indicates more severe dyspnea. The Transitional Dyspnea Index evaluates change in dyspnea as compared to the score obtained by the Baseline Dyspnea Index using a scale of -9 to +9. A negative score (-1 to -9) indicates worsening dyspnea as compared to baseline, a positive score (+1 to +9) indicates improvement in dyspnea as compared to baseline, and a score of 0 indicates no change in dyspnea as compared to baseline.
Time frame: 30 days through 180 days
Change in hemoptysis, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment using categorical measures (worsened, unchanged, improved, resolved)
Time frame: 30 days through 180 days
Change in cough, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment using categorical measures (worsened, unchanged, improved, resolved)
Time frame: 30 days through 180 days
Change in Karnofsky performance status, if present, at 30, 60, 90, and 180 days after the last PDT or APC treatment using categorical measures (worsened, unchanged, improved, resolved).
Time frame: 30 days through 180 days
Proportion of patients experiencing treatment failure at 90 days
Treatment failure is defined as failure to improve airway patency, airway re-obstruction, need for additional airway intervention and/or worsening symptoms.
Time frame: 90 days
This study is terminated, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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