Endoscopic Therapy of Early Cancer in Barretts Esophagus
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Early Stage Esophageal Adenocarcinoma
- Sponsor
- Mayo Clinic
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Level of Dysplasia on Histology at 12 Months
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Kenneth K. Wang
Professor of Medicine
Mayo Clinic
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:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Level of Dysplasia on Histology at 12 Months
Time Frame: 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
Time Frame: 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.
Time Frame: 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.