Endoscopic Therapy of Early Cancer in Barretts Esophagus

Barrett Esophagus Clinical Trial

Official title:

Endoscopic Therapy of Early Cancer in Barretts Esophagus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217087
• Other study ID #: 1399-05
• Secondary ID: R01CA111603
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: November 23, 2015
• Start date: September 2005
• Est. completion date: June 2012

Study information

• Verified date: November 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Early Stage Esophageal Adenocarcinoma
• Esophageal Neoplasms

Intervention

Procedure:
• Endoscopic Mucosal Resection
Endoscopic mucosal resection at time of endoscopy if indicated.
• Photodynamic Therapy
Porfimer sodium 2mg/kg

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months post therapy	No
Primary	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.	12 months post therapy	No
Primary	Change in Quality of Life	Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36	end of study	No