Endoscopic Therapy of Early Cancer in Barretts Esophagus

NCT00217087 | Completed Phase 2 Results DMC

• 2 other identifiers: 1399-05R01CA111603
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Stage Esophageal Adenocarcinoma; Barrett Esophagus

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Change in Quality of Life

  Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36

  end of study

Study Arms (2)

Endoscopic Mucosal Resection

OTHER

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

Procedure: Endoscopic Mucosal Resection

Photodynamic Therapy

OTHER

Patients will have endoscopic mucosal resection with photodynamic therapy.

Procedure: Endoscopic Mucosal Resection; Procedure: Photodynamic Therapy

Interventions

Endoscopic Mucosal Resection PROCEDURE

Endoscopic mucosal resection at time of endoscopy if indicated.

Endoscopic Mucosal Resection; Photodynamic Therapy

Photodynamic Therapy PROCEDURE

Porfimer sodium 2mg/kg

Also known as: Photofrin

Photodynamic Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Endoscopic Mucosal Resection; Photochemotherapy; Dihematoporphyrin Ether

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Kenneth Wang MD
• Organization: Mayo Clinic

wang.kenneth@mayo.edu

507-255-7495

Study Officials

• Kenneth K. Wang, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2005
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 24, 2015
• Results First Posted: September 25, 2015

Record last verified: 2015-11

Locations

US (1)