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Trial of Photodynamic Therapy Versus Argon Plasma Coagulation for Lung Cancer With Endobronchial Obstruction

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ClinicalTrials.gov Identifier: NCT03564054
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Concordia Laboratories Inc.
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Procedure: Photodynamic Therapy Procedure: Argon Plasma Coagulation Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Center, Randomized Trial of Photodynamic Therapy Versus Argon Plasma Coagulation for Lung Cancer With Endobronchial Obstruction
Actual Study Start Date : August 3, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Photodynamic Therapy
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
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.

Experimental: Argon Plasma Coagulation
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 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.




Primary Outcome Measures :
  1. Treatment time until failure [ Time Frame: 90 days ]
    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 .


Secondary Outcome Measures :
  1. 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 [ Time Frame: 30 days through 180 days ]
    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.

  2. 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 [ Time Frame: 30 days through 180 days ]
    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

  3. Median survival time [ Time Frame: 6 months ]
    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

  4. Percent reduction in airway obstruction as measured by bronchoscopy at 30 and 90 days after the last PDT or APC treatment [ Time Frame: 30 days through 90 days ]
    Percent reduction in airway obstruction will be calculated with the formula: [(baseline obstruction percentage - residual obstruction percentage)/baseline obstruction percentage x 100%].

  5. Resolution of atelectasis, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment [ Time Frame: 30 days through 180 days ]
    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.

  6. Resolution of post-obstructive pneumonia, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment [ Time Frame: 30 days through 180 days ]
    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.

  7. 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 [ Time Frame: 30 days through 180 days ]
    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.

  8. 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 ]
  9. 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 ]
  10. 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 ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent obtained from the subject or the subject's legal representative and the ability for the subject to comply with all the study-related procedures.
  • Subjects must have a biopsy proven for non-small cell lung cancer with obstructing or partially obstructing endobronchial tumor involving the main stem bronchus or bronchus intermedius, with or without extrabronchial tumor.
  • Both males and females ≥ eighteen years of age
  • Subject must demonstrate at least a 50% airway stenosis due to endobronchial tumor.
  • Subject must demonstrate symptoms of cough, hemoptysis, dyspnea etc. attributable to partially or completely occluding endobronchial tumor.
  • Subject is able to tolerate multiple bronchoscopies.
  • Subjects who were previously treated with chemotherapy or radiotherapy are eligible for study entry. Such subjects must be at least 3 weeks post-chemotherapy and/or radiotherapy and must have recovered from all acute toxicities associated with such treatment.
  • A predicted life expectancy of at least 90 days.

Exclusion Criteria:

  • Prior treatment of bronchogenic carcinoma with PDT or with APC.
  • Subjects with tracheal lesions or carinal lesions that compromise both main stem bronchi.
  • Subjects who have undergone pneumonectomy.
  • Tumor involving or eroding into major blood vessels.
  • Presence of a tracheoesophageal or bronchoesophageal fistula.
  • Subjects receiving concurrent systemic chemotherapy (excluding targeted therapies) and/or concurrent external beam radiation therapy.
  • Chemotherapy and/or radiation therapy within the previous three weeks.
  • Inability to adhere to sunlight precautions.
  • Severe hepatic impairment.
  • Severe renal impairment.
  • Porphyria or hypersensitivity to porphyrins.
  • Subjects requiring supplemental O2 with a flow of greater than 3 lpm to keep resting oxygen saturations greater than 90%.
  • History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
  • Subjects demonstrating an inability to comply with the study and/or follow-up procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564054


Contacts
Contact: Alisha Daniels, MD (352) 294-8568 alisha.daniels@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Erin Silverman, PhD         
Principal Investigator: Hiren Mehta, MD         
Sponsors and Collaborators
University of Florida
Concordia Laboratories Inc.
Investigators
Principal Investigator: Michael Jantz, MD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03564054     History of Changes
Other Study ID Numbers: UF-THO-001
RGA030 ( Other Grant/Funding Number: Concordia Laboratories, Inc. )
UF-PDO-THO-1001 ( Other Identifier: University of Florida Cancer Center )
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Florida:
non small cell lung cancer
photodynamic therapy
argon plasma coagulation
endobronchial obstruction

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms