Endoscopic Therapy of Early Cancer in Barretts Esophagus
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2005 |
| End Date: | June 2012 |
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.
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.
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.
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.
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.
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