CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
Endoscopic Mucosal Resection +1 moreprocedure
Likely dose
Porfimer sodium 2 mg/kgAI-extracted
Key inclusion· 7
  • Non-recurrent adenocarcinoma in Barrett's Esophagus confirmed by two experienced gastrointestinal pathologists
  • No evidence of submucosal invasion (T1a disease)
  • No evidence of metastatic disease in regional or distal lymph nodes or other organs
  • Pre-entry CT scans of upper abdomen and chest and Endoscopic Ultrasound (EUS) of tumor and regional lymph nodes required
Key exclusion· 4
  • Prior major esophageal surgery
  • Unable to tolerate endoscopic procedures
  • Uncontrolled diabetes, heart disease, or hypertension
  • Pregnant or lactating women, or men unable or unwilling to practice contraception

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00217087
NCT00217087Phase 2Completed

Endoscopic Therapy of Early Cancer in Barretts Esophagus

Mayo Clinic·interventional·Posted Sep 22, 2005·Updated Dec 24, 2015

In Brief

A Phase 2 clinical trial evaluating Endoscopic Mucosal Resection and Photodynamic Therapy for Early Stage Esophageal Adenocarcinoma and Barrett Esophagus. Completed, enrolled 73 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartSep 1, 2005
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 20.8 years ago

Interventions

Endoscopic Mucosal Resectionprocedure

Endoscopic mucosal resection at time of endoscopy if indicated.

Photodynamic Therapyprocedure

Porfimer sodium 2mg/kg