Know Cancer

forgot password

Phase 2
20 Years
80 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

Esophageal cancer is common in some areas , ranking 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 current study is
designed to demonstrate the preliminary results with this irradiation stent in patients with
inoperable esophageal cancer compared to those using a conventional covered stent.

Inclusion Criteria:

- 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,

Exclusion Criteria:

- Esophageal fistulas,

- Tracheal compression with symptoms,

- WBC <2000/mm3 and Platelet count <50,000/mm3,

- Concurrent therapies:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Principal Investigator

Gao-Jun Teng, MD. Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhongda Hospital, Southeast University


China: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

December 2006

Related Keywords:

  • Esophageal Cancer
  • esophageal Cancer
  • Dysphagia
  • Stent
  • interstitial brachytherapy
  • Esophageal Diseases
  • Esophageal Neoplasms