Endoscopic Therapy of Early Cancer in Barretts Esophagus

November 23, 2015 updated by: Kenneth K. Wang, Mayo Clinic
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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 Names:
  • Photofrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months post therapy
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.
12 months post therapy
Change in Quality of Life
Time Frame: end of study
Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36
end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kenneth K. Wang, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 24, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1399-05
  • R01CA111603 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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