Endoscopic Therapy of Early Cancer in Barretts Esophagus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Endoscopic Therapy of Early Cancer in Barretts Esophagus

Conditions
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Early Stage Esophageal Adenocarcinoma, Barrett Esophagus

Intervention / Treatment
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* Procedure: Endoscopic Mucosal Resection
* Procedure: Photodynamic Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Endoscopic Mucosal Resection<br>Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated. | Procedure: Endoscopic Mucosal Resection<br>* Endoscopic mucosal resection at time of endoscopy if indicated.<br>|
| Other: Photodynamic Therapy<br>Patients will have endoscopic mucosal resection with photodynamic therapy. | Procedure: Endoscopic Mucosal Resection<br>* Endoscopic mucosal resection at time of endoscopy if indicated.<br>Procedure: Photodynamic Therapy<br>* Porfimer sodium 2mg/kg<br>* Other names: Photofrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 12 months post therapy | 
| Change in Quality of Life | Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36 | end of study |