Trial Using 125I Embedded Stent in Patients With Advanced Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Southeast University, China.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Southeast University, China
ClinicalTrials.gov Identifier:
NCT00826813
First received: January 21, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Esophageal Cancer
Device: Esophageal stent placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study of Self-Expandable Esophageal Stent Loaded With 125I Seeds: a Randomized Controlled Multiple Center Trial in Patients With Advanced Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Death of the patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Restenosis of the stent [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Dysphagia relief [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: January 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stenting
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
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.
Other Name: esophageal stent implantation

Detailed Description:

Esophageal cancer ranks as the fourth leading cause of death from cancer in China and sixth worldwide. Although the prognosis of surgical resection for esophageal cancer has been improved, more than 50% of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, brachytherapy has previously been utilized. Recently, stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures. 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 technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model. The following preliminary clinical study in a single institute has demonstrated longer survival time, better quality of life and less restenosis of the stent than whose with 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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826813

Locations
China, Jiangsu
#87 Dingjiaqiao Road
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Southeast University, China
Investigators
Principal Investigator: Gao-Jun Teng, MD, Ph.D Zhongda Hospital, Southeast University
  More Information

Publications:
Responsible Party: Xiao-Hui Chen, MD, Zhongda Hospital, Department of Radiology
ClinicalTrials.gov Identifier: NCT00826813     History of Changes
Other Study ID Numbers: 2009A123456, H200343
Study First Received: January 21, 2009
Last Updated: January 21, 2009
Health Authority: China: Ethics Committee

Keywords provided by Southeast University, China:
Dysphagia
esophageal cancer
stent
brachytherapy

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 22, 2014