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Endoscopic Therapy of Early Cancer in Barretts Esophagus

Primary Purpose

Early Stage Esophageal Adenocarcinoma, Barrett Esophagus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Mucosal Resection
Photodynamic Therapy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Stage Esophageal Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Endoscopic Mucosal Resection

Photodynamic Therapy

Arm Description

Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.

Patients will have endoscopic mucosal resection with photodynamic therapy.

Outcomes

Primary Outcome Measures

Level of Dysplasia on Histology at 12 Months
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.
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
Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36

Secondary Outcome Measures

Full Information

First Posted
September 20, 2005
Last Updated
November 23, 2015
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00217087
Brief Title
Endoscopic Therapy of Early Cancer in Barretts Esophagus
Official Title
Endoscopic Therapy of Early Cancer in Barretts Esophagus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Esophageal Adenocarcinoma, Barrett Esophagus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic Mucosal Resection
Arm Type
Other
Arm Description
Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
Arm Title
Photodynamic Therapy
Arm Type
Other
Arm Description
Patients will have endoscopic mucosal resection with photodynamic therapy.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Mucosal Resection
Intervention Description
Endoscopic mucosal resection at time of endoscopy if indicated.
Intervention Type
Procedure
Intervention Name(s)
Photodynamic Therapy
Other Intervention Name(s)
Photofrin
Intervention Description
Porfimer sodium 2mg/kg
Primary Outcome Measure Information:
Title
Level of Dysplasia on Histology at 12 Months
Description
All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus
Time Frame
12 months post therapy
Title
Fluorescence In Situ Hybridization (FISH) Markers at 12 Months.
Description
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.
Time Frame
12 months post therapy
Title
Change in Quality of Life
Description
Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36
Time Frame
end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth K. Wang, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Endoscopic Therapy of Early Cancer in Barretts Esophagus

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