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

Not Applicable

Terminated

• Conditions: Non Small Cell Lung Cancer
• Interventions: Procedure: Photodynamic Therapy; Procedure: Argon Plasma Coagulation

• Registration Number: NCT03564054
• Lead Sponsor: 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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-20
• Study Start: 2018-10-11
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Written informed consent obtained from the subject 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, or lobar bronchus 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 2 weeks post-radiotherapy and must have recovered from all acute toxicities associated with such treatment.
• A predicted life expectancy of at least 90 days.

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Exclusion Criteria

• Prior treatment of non-small cell carcinoma with PDT or with APC in the last 3 months.
• 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 external beam radiation therapy.
• Radiation therapy within the previous two 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.
• Females who are pregnant.
• Individuals who cannot provide consent themselves.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photodynamic Therapy	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
Argon Plasma Coagulation	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.

Primary Outcome Measures

Name	Time	Method
Treatment time until failure	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

Name	Time	Method
Median survival time	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
Percent reduction in airway obstruction as measured by bronchoscopy at 30 and 90 days after the last PDT or APC treatment	30 days through 90 days	Percent reduction in airway obstruction will be calculated with the formula: \[(baseline obstruction percentage - residual obstruction percentage)/baseline obstruction percentage x 100%\].
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	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.
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	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.
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	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
Resolution of atelectasis, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment	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.
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)	30 days through 180 days
Proportion of patients experiencing treatment failure at 90 days	90 days	Treatment failure is defined as failure to improve airway patency, airway re-obstruction, need for additional airway intervention and/or worsening symptoms.
Resolution of post-obstructive pneumonia, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment	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.
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)	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).	30 days through 180 days

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States