Case Analysis on Real Life Incidence of Photodynamic Therapy (PDT) Safety Outcomes

NCT01203163 | Withdrawn

• 1 other identifier: MA-PO-PHORC07-01
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Three main adverse reactions, namely photosensitivity (reaction that is similar to sunburn), oesophageal stenosis (narrowing or closure of the food pipe), perforation of the treated area (a tear or puncture of the tissue), have been identified in research studies evaluating photodynamic therapy (PDT) with porfimer sodium. Because of the low incidence of the disease or the variation in the occurrence of these adverse reactions among different indications, it is difficult to determine the occurrence and frequency of these safety issues in routine clinical practice. This post-marketing safety surveillance registry is set-up to evaluate the safety of PDT using porfimer sodium. A registry allows the collection of data to evaluate real-world results in the practice of medicine. The registry will monitor the patient's health and any events, with a main focus on photosensitivity, oesophageal stenosis, and perforation of the treated area. This registry will involve 500 patients, across 20 to 36 hospitals in the US and Europe, scheduled to receive an injection of porfimer sodium with PDT for the treatment of lung cancer, esophageal \[food pipe\] cancer, or high-grade dysplasia (HGD) (precancerous change in the food pipe tissue) in Barrett's esophagus.

Conditions

Esophageal Cancer; Lung Cancer; Barrett's Esophagus

Keywords

PDT; porfimer sodium; esophageal cancer; NSCLC; HGD in BE

Outcome Measures

Primary Outcomes (1)

• Proportion of patients experiencing Adverse Reactions of Special Interest

  Proportion of patients experiencing photosensitivity reaction, oesophageal stenosis, and/or perforation at the site of laser light application after PDT.

  3 months

Secondary Outcomes (3)

• Incidence of the photosensitivity reaction in patients with liver insufficiency (disease)

  3 months

• Relationships between photosensitivity reaction and skin color

  3 months

• Overall safety in patients with renal insufficiency (disease)

  3 months

Study Arms (1)

PDT with porfimer sodium

Eligibility Criteria

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

Study Population

Patients suffering from esophageal cancer, lung cancer, or HGD in Barrett's esophagus and scheduled to undergo PDT with porfimer sodium

You may qualify if:

• Patients scheduled to undergo PDT with Photofrin
• Patients must have the mental, literate, and legal ability to give a written informed consent, which must comply with the International Conference on Harmonization (ICH) guidelines and local requirements.

You may not qualify if:

• Patients treated with Photosan®
• Patients being treated with any investigational drug or participating in any interventional studies, with the exception of investigational photoprotection measures.
• Patients who are unable or unwilling to complete the follow-up evaluations required for the registry.

Sponsors & Collaborators

• Pinnacle Biologics Inc.: lead

MeSH Terms

Conditions

Esophageal Neoplasms; Lung Neoplasms; Barrett Esophagus

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Precancerous Conditions

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Last Updated: May 9, 2012

Record last verified: 2012-05