Endoscopic Therapy of Early Cancer in Barretts Esophagus

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2012

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.

Interventions

  • Procedure: Endoscopic Mucosal Resection
    • Endoscopic mucosal resection at time of endoscopy if indicated.
  • Procedure: Photodynamic Therapy
    • Porfimer sodium 2mg/kg

Arms, Groups and Cohorts

  • Other: Endoscopic Mucosal Resection
    • Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
  • Other: Photodynamic Therapy
    • Patients will have endoscopic mucosal resection with photodynamic therapy.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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.
  • Change in Quality of Life
    • Time Frame: end of study
    • Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kenneth K. Wang, Professor of Medicine – Mayo Clinic
  • Overall Official(s)
    • Kenneth K. Wang, M.D., Principal Investigator, Mayo Clinic

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