Clinical trial NCT00217087: Endoscopic Therapy of Early Cancer in Barretts Esophagus
Official title: Endoscopic Therapy of Early Cancer in Barretts Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Early Stage Esophageal Adenocarcinoma
Barrett Esophagus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-22
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

* 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.

Primary outcomes:
measure: Level of Dysplasia on Histology at 12 Months
timeFrame: 12 months post therapy
measure: Fluorescence In Situ Hybridization (FISH) Markers at 12 Months.
timeFrame: 12 months post therapy
measure: Change in Quality of Life
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kenneth K. Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: