Endoscopic Therapy of Early Cancer in Barretts Esophagus

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00217087

First received: September 20, 2005

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 20, 2005

Last Updated Date

February 26, 2013

Start Date ^ICMJE

September 2005

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To examine whether photodynamic therapy in addition to endoscopic mucosal resection will decrease cancer recurrence in early esophageal adenocarcinoma [ Time Frame: end of study ] [ Designated as safety issue: No ]
To identify biomarkers which identify patients who will respond to endoscopic therapy [ Time Frame: end of study ] [ Designated as safety issue: No ]
Evaluate the health related quality of life in patients undergoing endoscopic mucosal resection with and without photodynamic therapy [ Time Frame: end of study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To examine whether photodynamic therapy in addition to endoscopic mucosal resection will decrease cancer recurrence in early esophageal adenocarcinoma
To identify biomarkers which identify patients who will respond to endoscopic therapy
Evaluate the health related quality of life in patients undergoing endoscopic mucosal resection with and without photodynamic therapy

Change History

Complete list of historical versions of study NCT00217087 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess biomarkers in the Barretts esophagus using cytology [ Time Frame: end of study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To assess biomarkers in the Barretts esophagus using cytology

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endoscopic Therapy of Early Cancer in Barretts Esophagus

Official Title ^ICMJE

Endoscopic Therapy of Early Cancer in Barretts Esophagus

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Early Stage Esophageal Adenocarcinoma
Barrett Esophagus

Intervention ^ICMJE

Procedure: Endoscopic Mucosal Resection
Endoscopic Mucosal resection at time of endoscopy if indicated
Procedure: photodynamic therapy
porfimer sodium 2mg/kg

Study Arm (s)

endoscopic mucosl resection
patients will undergo endoscopic mucosal resection at time of endoscopy if indicated

Intervention: Procedure: Endoscopic Mucosal Resection
photodynamic therapy
patients will have endoscopic mucosal resection with photodynamic therapy

Intervention: Procedure: photodynamic therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Early esophageal cancer in Barrett's Esophagus in patients not eligible for surgical or radiological therapy. Participants must be have oral intake of greater than 1700 calories a day. No history of prior cancer within the past 5 years. And have no history of extensive prior esophageal surgery (example: esophagectomy)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00217087

Other Study ID Numbers ^ICMJE

1399-05, CA111603-01A1

Has Data Monitoring Committee

Yes

Responsible Party

Kenneth K Wang MD, Mayo Clinic

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Kenneth K. Wang, M.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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