NCT00477841

Brief Summary

To determine the response to treatment with a novel esophageal stent loaded with 125I seeds for intraluminal brachytherapy versus a conventional covered stent in patients with advanced esophageal cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
Last Updated

April 18, 2008

Status Verified

May 1, 2007

First QC Date

May 22, 2007

Last Update Submit

April 17, 2008

Conditions

Esophageal Cancer

Keywords

esophageal CancerDysphagiaStentinterstitial brachytherapy

Outcome Measures

Primary Outcomes (1)

  • Relief of dysphagia measured by dysphagia scores, survival time from the interventional procedure to the last follow-up.

    Follow-up in intervals of 1, 3, 6 and 12 months after stent placement

Secondary Outcomes (1)

  • Successful rate of stent placement, Stent-related complications and morbidity, Overall rate of mortality

    Follow-up in intervals of 1, 3, 6, and 12 months after stent placement

Interventions

Esophageal stent placementPROCEDURE
dysphagia scoresPROCEDURE
complications of therapyPROCEDURE
survival time of therapyPROCEDURE

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed primary cancer of esophagus,
  • Must be dysphagia caused by esophageal cancer,
  • Surgically inoperable, but may be metastatic,
  • Without esophageal fistulas,
  • Must be an inpatient at Zhongda Hospital,
  • Life expectancy is over 6 months,

You may not qualify if:

  • Esophageal fistulas,
  • Tracheal compression with symptoms,
  • WBC \<2000/mm3 and Platelet count \<50,000/mm3,
  • Concurrent therapies:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

  • Guo JH, Teng GJ, Zhu GY, He SC, Deng G, He J. Self-expandable stent loaded with 125I seeds: feasibility and safety in a rabbit model. Eur J Radiol. 2007 Feb;61(2):356-61. doi: 10.1016/j.ejrad.2006.10.003. Epub 2006 Nov 7.

    PMID: 17085003BACKGROUND

MeSH Terms

Conditions

Esophageal NeoplasmsDeglutition Disorders

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Gao-Jun Teng, MD. Ph.D

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 22, 2007

First Posted

May 24, 2007

Study Start

April 1, 2004

Study Completion

December 1, 2006

Last Updated

April 18, 2008

Record last verified: 2007-05

Locations

CN(1)