Esophageal Cancer Clinical Trial
Official title:
A Phase II Study of the Safety and Efficacy of Photodynamic Therapy in Carcinoma in Situ of the Esophagus
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive
to light to kill tumor cells. This may be an effective treatment for esophageal cancer.
PURPOSE: Phase II trial to study the effectiveness of photodynamic therapy in treating
patients with Barrett's esophagus who have in situ esophageal cancer.
OBJECTIVES: I. Evaluate the efficacy of photodynamic therapy (PDT) using porfimer sodium
(Photofrin) and controlled uniform laser light in patients with carcinoma in situ in
Barrett's esophagus or severe dysplasia in Barrett's esophagus. II. Evaluate the safety of
the treatment on this patient.
OUTLINE: This is a noncomparative study. PDT consists of IV porfimer sodium followed 40-50
hours later by laser red light delivered by optic fibers passed through the biopsy channel
of an endoscope. Retreatment, if necessary, consists of up to 3 injections at least 30 days
apart and up to 6 laser light treatments, with a maximum of 2 following each injection.
Patients are followed monthly for 4 months, and then periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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