Endoscopic Therapy of Early Cancer in Barretts Esophagus

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
First received: September 20, 2005
Last updated: August 26, 2015
Last verified: April 2015

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.

Condition Intervention Phase
Early Stage Esophageal Adenocarcinoma
Barrett Esophagus
Procedure: Endoscopic Mucosal Resection
Procedure: Photodynamic Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Therapy of Early Cancer in Barretts Esophagus

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Level of Dysplasia on Histology at 12 Months [ Time Frame: 12 months post therapy ] [ Designated as safety issue: No ]
    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) Makers at 12 Months. [ Time Frame: 12 months post therapy ] [ Designated as safety issue: No ]
    Whether or not positive fish markers measured by polysomy were associated with outcomes.

  • Change in Quality of Life [ Time Frame: end of study ] [ Designated as safety issue: No ]
    Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36

Enrollment: 73
Study Start Date: September 2005
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Endoscopic Mucosal Resection
Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
Procedure: Endoscopic Mucosal Resection
Endoscopic mucosal resection at time of endoscopy if indicated.
Photodynamic Therapy
Patients will have endoscopic mucosal resection with photodynamic therapy.
Procedure: Endoscopic Mucosal Resection
Endoscopic mucosal resection at time of endoscopy if indicated.
Procedure: Photodynamic Therapy
Porfimer sodium 2mg/kg
Other Name: Photofrin

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00217087

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Kenneth K. Wang, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Kenneth K. Wang, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00217087     History of Changes
Other Study ID Numbers: 1399-05, R01CA111603
Study First Received: September 20, 2005
Results First Received: March 2, 2015
Last Updated: August 26, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Barrett Esophagus
Esophageal Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 09, 2015