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

NCT03564054 | Terminated DMC

• 4 other identifiers: UF-THO-001RGA030UF-PDO-THO-1001OCR17811
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Non Small Cell Lung Cancer

Keywords

non small cell lung cancer; photodynamic therapy; argon plasma coagulation; endobronchial obstruction

Outcome Measures

Primary Outcomes (1)

• 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 .

  90 days

Secondary Outcomes (11)

• 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

• 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

• Median survival time

  6 months

• 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

• 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

Study Arms (2)

Photodynamic Therapy

EXPERIMENTAL

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

EXPERIMENTAL

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

Interventions

Photodynamic Therapy PROCEDURE

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.

Photodynamic Therapy

Argon Plasma Coagulation PROCEDURE

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.

Argon Plasma Coagulation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Concordia Laboratories Inc.: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Photochemotherapy; Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Electrocoagulation; Cautery; Hemostatic Techniques; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical

Study Officials

• Michael Jantz, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 20, 2018
• Study Start: October 11, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

US (1)