Endoesophageal Cryotherapy For Ablating Barrett's Esophagus and Early Stage Esophageal Cancer

Status unconfirmed · Phase 4

Conditions studied: Barrett's Esophagus

In brief

In this prospective single center study, up to 25 patients with Barrett's esophagus with LGD or no dysplasia (Group 1), 25 patients with HGD/IMCA (Group 2), 25 patients with esophageal carcinoma confined to the esophageal wall (Group 3) and 25 patients with severe esophageal squamous dysplasia (Group 4) will be treated with endoscopic cryotherapy. This study is single arm and no blinding will be utilized. Interim analysis of the data will be reviewed with a DCI statistician after 14 patients in each group have been treated with cryotherapy and if safety and efficacy is documented to that point in time, we will request the ability to extend the enrollment to a maximum allowable amount of 25 patients per group. The proposed study duration is seven years, allowing two years for patient enrollment and 5 years for post treatment follow-up. Study duration per patient will total approximately six years. Patients with Barrett's esophagus with no dysplasia or low grade dysplasia (group 1) will be treated with cryotherapy at six week intervals until Barrett's mucosa is ablated or six treatments are administered. Patients with Barrett's HGD and IMCA or severe esophageal squamous dysplasia (groups 2 and 4) will be treated with cryotherapy at six-week intervals until Barrett's mucosa is ablated or six treatments are administered. More advanced mass lesions are typically more difficult to eradicate with ablative therapies and may progress faster than patients with IMCA, therefore, patients with more advanced cancer (group 3) will be treated every 2 weeks until the lesion is eradicated up to eight treatments. After cryotherapy treatment is complete (i.e. the esophagus has re-epithelialized with normal squamous epithelium for Groups 1, 2, 4 and the tumor is locally controlled/absent in Group 3), patients will be assessed by endoscopy and biopsy every three months for one year, every six months for two years, then annually for two years (flow sheet - appendix 1; study schedule - appendix 2).

Key facts

Study ID: NCT00628784
Run by: Walter Reed Army Medical Center
People needed: 100
Starts: 2007-03-01
Expected to finish: 2012-03-01
Last updated by the study team: 2008-07-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

** You must be eligible for care within the Department of Defense (DEERS eligible) to be enrolled into this protocol **
Per Groups 1,2,3,4 (above)
Specifically:
Diagnosis of specialized intestinal metaplasia (Barrett's esophagus) with either low grade, indeterminate or no dysplasia (Group 1)
high grade or intramucosal cancer and deemed inoperable based on co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention; CT scan and EUS demonstrating no evidence of trans-mural tumor or lymph node involvement; pathology review of esophageal biopsies by 2 independent reviewers to include 1 from the Walter Reed Army Medical Center Pathology Department; presentation at tumor board (Group 2)
T1smN0 or T2NO adenocarcinoma arising in Barrett's esophagus and all criteria as for group 2 (Group 3)
diagnosis of severe squamous dysplasia and all criteria as for group 2 (Group 4)

You may not qualify if…

Not eligible for care within the Department of Defense medical system
Age less than 18 years or greater then 85 years (at time of entry)
Co-morbid illness expected to cause death within 6 months
Pregnancy (as determined by urine HCG)
Medically unfit or other contraindications to tolerate upper endoscopy
Inability to tolerate therapy with a proton pump inhibitor
Refusal or inability to give consent

Where it is running

Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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