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OpenTrials
Completed

NCT Number: NCT00217087

Endoscopic Therapy of Early Cancer in Barretts Esophagus

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic mucosal resection

Procedure

Endoscopic mucosal resection at time of endoscopy if indicated.

Photodynamic Therapy

Procedure

Porfimer sodium 2mg/kg

Other names: Photofrin

Primary outcomes

  1. Level of Dysplasia on Histology at 12 Months

    Time frame: 12 months post therapy

    All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus

  2. Fluorescence In Situ Hybridization (FISH) Markers at 12 Months.

    Time frame: 12 months post therapy

    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.

  3. Change in Quality of Life

    Time frame: end of study

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2005
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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