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Endoscopic Therapy of Early Cancer in Barretts Esophagus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00217087
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : September 25, 2015
Last Update Posted : December 24, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Therapy of Early Cancer in Barretts Esophagus
Study Start Date : September 2005
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217087


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kenneth K. Wang, M.D. Mayo Clinic
More Information
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Responsible Party: Kenneth K. Wang, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00217087    
Other Study ID Numbers: 1399-05
R01CA111603 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Results First Posted: September 25, 2015
Last Update Posted: December 24, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Barrett Esophagus
Neoplasms
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Dihematoporphyrin Ether
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents