Endoscopic Therapy of Early Cancer in Barretts Esophagus

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00217087
First received: September 20, 2005
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Early Stage Esophageal Adenocarcinoma
Barrett Esophagus
Procedure: Endoscopic Mucosal Resection
Procedure: photodynamic therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Therapy of Early Cancer in Barretts Esophagus

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 88
Study Start Date: September 2005
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
endoscopic mucosl 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: photodynamic therapy
porfimer sodium 2mg/kg

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217087

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kenneth K. Wang, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Kenneth K Wang MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00217087     History of Changes
Other Study ID Numbers: 1399-05, CA111603-01A1
Study First Received: September 20, 2005
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Barrett Esophagus
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014