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Endoscopic Therapy of Early Cancer in Barretts Esophagus

NCT ID: NCT00217087

Last Updated: 2015-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Early Stage Esophageal Adenocarcinoma Barrett Esophagus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic Mucosal Resection

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

Group Type OTHER

Endoscopic Mucosal Resection

Intervention Type PROCEDURE

Endoscopic mucosal resection at time of endoscopy if indicated.

Photodynamic Therapy

Patients will have endoscopic mucosal resection with photodynamic therapy.

Group Type OTHER

Endoscopic Mucosal Resection

Intervention Type PROCEDURE

Endoscopic mucosal resection at time of endoscopy if indicated.

Photodynamic Therapy

Intervention Type PROCEDURE

Porfimer sodium 2mg/kg

Interventions

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Endoscopic Mucosal Resection

Endoscopic mucosal resection at time of endoscopy if indicated.

Intervention Type PROCEDURE

Photodynamic Therapy

Porfimer sodium 2mg/kg

Intervention Type PROCEDURE

Other Intervention Names

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Photofrin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kenneth K. Wang

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth K. Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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R01CA111603

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1399-05

Identifier Type: -

Identifier Source: org_study_id