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

Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - 99
Start Date:October 11, 2018
End Date:September 2021
Contact:Meghan Vazquez, RN, BSN
Phone:(352) 273-6843

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Multi-Center, Randomized Trial of Photodynamic Therapy Versus Argon Plasma Coagulation for Lung Cancer With Endobronchial Obstruction

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.

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

- 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

- 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

- 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
We found this trial at
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Jason Akulian, MD, MPH
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
Chapel Hill, NC
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Hiren Mehta, MD
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
Gainesville, FL
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171 Ashley Avenue
Charleston, South Carolina 29425
Principal Investigator: Nicholas Pastis, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
Charleston, SC
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Elk Grove Village, Illinois 60007
Principal Investigator: Neeraj Desai, MD
Elk Grove Village, IL
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