Endoscopic Therapy of Early Cancer in Barretts Esophagus

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Early Stage Esophageal Adenocarcinoma; Barrett Esophagus

Treatments: Procedure: Photodynamic Therapy; Procedure: Endoscopic Mucosal Resection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00217087

1399-05

R01CA111603 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

73 participants in 2 patient groups

Endoscopic Mucosal Resection

Other group

Description:

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

Treatment:

Procedure: Endoscopic Mucosal Resection

Photodynamic Therapy

Other group

Description:

Patients will have endoscopic mucosal resection with photodynamic therapy.

Treatment:

Procedure: Endoscopic Mucosal Resection

Procedure: Photodynamic Therapy