This study is being done to see if treatment for esophageal cancer can be done using endoscopy for patients ineligible for surgical or radiological therapy. The standard method of treating this type of cancer is surgical removal of the esophagus. The study will determine if removing just the cancer with endoscopy is enough treatment or if the addition of another treatment called photodynamic therapy (treatment with a red light and a drug called sodium porfimer) is needed.
Participant visit requirements: Screening visit which will last 1 - 2 days, if assigned to photodynamic therapy, there will be a 3 day visit for treatment. Participants must return for a 1 day visit every three months for one year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Endoscopic mucosal resection at time of endoscopy if indicated.
Porfimer sodium 2mg/kg
Mayo Clinic
Rochester, Minnesota, United States
Level of Dysplasia on Histology at 12 Months
All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus
Time frame: 12 months post therapy
Fluorescence In Situ Hybridization (FISH) Markers at 12 Months.
Whether or not positive fish markers measured by polysomy were associated with outcomes. Markers in this study include: 9q21 /017q (her2) / 8q24/ 20q / CEP17 / 17p. Polysomy and Trisomy were documented.
Time frame: 12 months post therapy
Change in Quality of Life
Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36
Time frame: end of study
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