NCT00826813

Brief Summary

More than half of patients with esophageal cancer are inoperable because of late stage cancer or metastasis and they have to undergo palliative treatments. Dysphagia is the major symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, stent placement has been widely accepted to be an option for palliation of the symptoms. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The preliminary clinical trial in a single institute has demonstrated better results than the conventional stent. This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 22, 2009

Status Verified

January 1, 2009

Enrollment Period

1.2 years

First QC Date

January 21, 2009

Last Update Submit

January 21, 2009

Conditions

Esophageal Cancer

Keywords

Dysphagiaesophageal cancerstentbrachytherapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Death of the patient

Secondary Outcomes (3)

  • Quality of life

    3, 6, 12 months

  • Restenosis of the stent

    3, 6, 12 months

  • Dysphagia relief

    3, 6, 12 months

Study Arms (1)

stenting

EXPERIMENTAL

The conventional esophageal stent or 125I radiation stent is placed in the patients with dysphagia who are enrolled to the study.

Device: Esophageal stent placement

Interventions

Esophageal stent placementDEVICE

The esophageal stent combined a self-expandable covered esophageal stent and 125I radioactive seeds. Sheathes were attached to the outer surface of the stent, containing 125I radioactive seeds of CIAE 6711. The seeds were loaded into the sheathes on the stent immediately before implantation of the stent. The numbers and dose of the radioactive stent seeds was determined by the treatment plan system based on the size of the individual tumor. To cover the entire lesion of the tumor by the sheaths containing 125I seeds, at least 2 cm exceeding the tumor margins was required. The distance between the two sheaths was 15mm. In the control group, conventional covered esophageal stents were used which provided by the same company as those attached with 125I seeds.

Also known as: esophageal stent implantation
stenting

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,
  • Without esophageal fistulas,
  • Must be an inpatient,
  • 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 after stenting:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

#87 Dingjiaqiao Road

Nanjing, Jiangsu, 210009, China

Location

Related Publications (2)

  • Guo JH, Teng GJ, Zhu GY, He SC, Fang W, Deng G, Li GZ. Self-expandable esophageal stent loaded with 125I seeds: initial experience in patients with advanced esophageal cancer. Radiology. 2008 May;247(2):574-81. doi: 10.1148/radiol.2472070999. Epub 2008 Mar 18.

    PMID: 18349316BACKGROUND

  • 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
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 22, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2011

Last Updated

January 22, 2009

Record last verified: 2009-01

Locations

CN(1)