Endoscopic Therapy of Early Cancer in Barretts Esophagus

Phase 2

Completed

Interventions: Procedure: Endoscopic Mucosal Resection
Procedure: Photodynamic Therapy

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Photodynamic Therapy	Endoscopic Mucosal Resection	Patients will have endoscopic mucosal resection with photodynamic therapy.
Endoscopic Mucosal Resection	Endoscopic Mucosal Resection	Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
Photodynamic Therapy	Photodynamic Therapy	Patients will have endoscopic mucosal resection with photodynamic therapy.

Primary Outcome Measures

Name	Time	Method
Level of Dysplasia on Histology at 12 Months	12 months post therapy	All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus
Change in Quality of Life	end of study	Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36
Fluorescence In Situ Hybridization (FISH) Markers at 12 Months.	12 months post therapy	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.