a Multicentric Randomized Controlled Trial of Self-Expandable Esophageal Radiation Stent

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Southeast University, China.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Gao-Jun Teng, Southeast University, China
ClinicalTrials.gov Identifier:
NCT01054274
First received: January 21, 2010
Last updated: March 30, 2012
Last verified: December 2009
  Purpose

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. Brachytherapy and esophageal self-expanding stent insertion have longer benefit. Stent insertion provides fastest improvement of dysphagia.However, recurrence of the neoplastic stricture remains a challenge after stent placement, complications in later setting occur and require further endoscopic treatment. Brachytherapy has slower onset of benefit but has fewer complications and longer benefit.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. And a small-sample and unicentric prior clinical trial in the authors' institute certificated the novel esophageal stent can relieve the dysphagia caused by advanced esophageal cancer rapidly and improve the quality of life markedly. This current multicentric randomized clinical trial is further studying the novel esophageal stent loaded with 125I seeds to see how well they work compared with a conventional covered stent in patients with malignant dysphagia caused by advanced esophageal cancer.


Condition Intervention Phase
Esophageal Cancer
Device: novel stent
Device: conventional covered stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Self-Expandable Esophageal Radiation Stent:a Multicentric Randomized Controlled 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 and Median Survival [ Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ECOG performance status],Dysphagia grade [STOOLER stand],Change of the oesophageal cancer [ RECIST standard],Restenosis degree[esophagus visualization] [ Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ] [ Designated as safety issue: Yes ]
  • Pathologic change of the cancer [ Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ] [ Designated as safety issue: Yes ]
  • Successful rate of stent placement [ Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: December 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: novel stent
Patients undergo placement of a novel esophageal stent loaded with 125I seeds on day 1.
Device: novel stent
Patients undergo placement of a novel esophageal stent loaded with 125I seeds on day 1.
Other Name: self-expandable esophageal radiation stent
Experimental: conventional covered stent
Patients undergo placement of a conventional covered stent on day 1.
Device: conventional covered stent
Patients undergo placement of a conventional covered stent on day 1.
Other Name: conventional stent

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Endoscopically and histologically confirmed cancer of esophagus
  • Progressive dysphagia caused by esophageal cancer, and the dysphagia grade of level Ⅲ or level Ⅳ[STOOLER stand]
  • In barium meal of esophagus, severe stricture of the cancer make the barium difficult to pass through and the superior normal esophagus broaden
  • The bulk and shape of the oesophageal cancer displayed by CT three-dimensional reconstruction
  • Patients with clear consciousness,Cooperation,ECOG performance status of 0,1 and 3
  • Informed consent: authorization and signature

Exclusion Criteria:

  • Poor general status,ECOG performance status of 4,
  • Dysphagia not caused by esophageal cancer,
  • Noncooperation or no authorization and signature.
  • The superior border of cancer higher than the seventh cervical vertebrae
  • Ulcerative esophageal carcinoma
  • Esophageal fistulas,
  • WBC less than 3000/mm3

    • Severe hepatic inadequacy or renal inadequacy,
  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: NCT01054274

Contacts
Contact: Gao-Jun Teng, MD +86 25 83272121 gjteng@vip.sina.com

Locations
China, Jiangsu
Zhongda Hospital, Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Southeast University, China
Investigators
Principal Investigator: Gao-Jun Teng, MD Medical School,Southeast University
  More Information

Publications:
Responsible Party: Gao-Jun Teng, Director, Southeast University, China
ClinicalTrials.gov Identifier: NCT01054274     History of Changes
Other Study ID Numbers: 320924197612177170
Study First Received: January 21, 2010
Last Updated: March 30, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Southeast University, China:
esophageal cancer
dysphagia
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 October 19, 2014