Clinical trial NCT03564054: Trial of Photodynamic Therapy Versus Argon Plasma Coagulation for Lung Cancer With Endobronchial Obstruction
Official title: Multi-Center, Randomized Trial of Photodynamic Therapy Versus Argon Plasma Coagulation for Lung Cancer With Endobronchial Obstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: non small cell lung cancer
photodynamic therapy
argon plasma coagulation
endobronchial obstruction
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Concordia Laboratories Inc.
First posted: 2018-06-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Treatment time until failure
timeFrame: 90 days
Secondary outcomes:
measure: 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
timeFrame: 30 days through 180 days
measure: 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
timeFrame: 30 days through 180 days
measure: Median survival time
timeFrame: 6 months
measure: Percent reduction in airway obstruction as measured by bronchoscopy at 30 and 90 days after the last PDT or APC treatment
timeFrame: 30 days through 90 days
measure: Resolution of atelectasis, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment
timeFrame: 30 days through 180 days
measure: Resolution of post-obstructive pneumonia, if present, at 30, 45, 60, 75, 90, and 180 days after the last PDT or APC treatment
timeFrame: 30 days through 180 days
measure: 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
timeFrame: 30 days through 180 days
measure: 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)
timeFrame: 30 days through 180 days
measure: 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)
timeFrame: 30 days through 180 days
measure: 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).
timeFrame: 30 days through 180 days
measure: Proportion of patients experiencing treatment failure at 90 days
timeFrame: 90 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Michael Jantz, MD
role: PRINCIPAL_INVESTIGATOR
References: