Endoscopic Therapy of Early Cancer in Barretts Esophagus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Level of Dysplasia on Histology at 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Level of Dysplasia on Histology at 12 Months
时间窗: 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
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Kenneth K. Wang
Professor of Medicine
Mayo Clinic