Endoscopic Therapy of Early Cancer in Barretts Esophagus
Completed · Phase 2
Conditions studied: Early Stage Esophageal Adenocarcinoma, Barrett Esophagus
In brief
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.
Key facts
- Study ID
- NCT00217087
- Run by
- Mayo Clinic
- People needed
- 73
- Starts
- 2005-09-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2015-12-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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