Endoscopic Therapy of Early Cancer in Barretts Esophagus
Early Stage Esophageal Adenocarcinoma, Barrett Esophagus
About this trial
This is an interventional treatment trial for Early Stage Esophageal Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: Non-recurrent adenocarcinoma in Barrett's Esophagus confirmed by two experienced gastrointestinal pathologists No evidence of submucosal invasion No evidence of metastatic disease in either regional or distal lymph nodes, or other organs Pre-entry CT scans of the upper abdomen and chest and Endoscopic Ultrasound (EUS) of the tumor and regional lymph nodes are required. Fusion PET scans are suggested for any indeterminate lesions Zubrod Performance Status 0-1 Participants must be have oral intake of greater than 1700 calories a day Patient must not have had a second malignancy, other than curable non-melanoma skin cancer or cervical cancer in situ, unless disease free for greater than or equal to 3 years and deemed cured by their hematologist and/or oncologist Staging procedures should be performed prior to study entry All patients or legally authorized representative must sign a study-specific informed consent prior to randomization. Exclusion criteria: Prior major esophageal surgery Patients who are unable to tolerate endoscopic procedures Due to the possible toxic effects of photodynamic therapy and endoscopic sedation to embryos, pregnant or lactating women or men unable or unwilling to practice contraception are excluded Patients with an uncontrolled diabetes, heart disease, or hypertension Patient and/or legally authorized representative who are unable to comprehend the study requirements or who are not likely to comply with the study parameters.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Other
Other
Endoscopic Mucosal Resection
Photodynamic Therapy
Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
Patients will have endoscopic mucosal resection with photodynamic therapy.